An interventional study of Remote Ischemic Conditioning and Sham Remote Ischemic Conditioning in Stroke, Acute, Ischemic Stroke and Hemorrhagic Stroke, sponsored by Grethe Andersen. Completed at 4 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-27.
Sponsored by Grethe Andersen · Not applicable, Interventional, and Treatment
Among 161 studies in Stroke with a site in Denmark — 29 open to participants now, 45 under way, 4 of them phase 3. Stroke · Denmark.
Among the 161 studies in Stroke with a site in Denmark, this one is the 35th largest by enrollment of the 113 interventional ones that give a count, is one of 9 that started in 2018, is one of 62 with no phase, and was the 89th registered.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
Browse Stroke studies →29 of the 161 studies in Stroke with a site in Denmark are open now. Recruiting first, the newest first:
University of Aarhus · Sites in Denmark
Ages 18+
University of Aarhus · Sites in Denmark
Ages 18+
Louise Møldrup Nielsen · Sites in Denmark
Ages 18+
Rigshospitalet, Denmark · Sites in Denmark
Ages 18+
Guri Hagberg · Sites in Denmark, Norway, Sweden
Ages 18+
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
161 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 9 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,500 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Median enrollment 361 across the 113 interventional studies, 138 across the 48 observational. Of the 105 that completed or were terminated, 27 (26%) have results posted.
This tab as a report to print or save as PDF → With an account.
40 of 161 have an industry lead sponsor. The 10 most frequent:
Grethe Andersen is the lead sponsor of 2 studies on the registry; none are open to participants now.
Grethe Andersen has 2 studies filed under Stroke — fewer than ten, so there is no comparison to draw.
7 of the studies in Stroke with a site in Denmark that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04709900Copenhagen University Hospital, RigshospitaletCT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes | 2026-12 |
| NCT06570681University of Southern DenmarkVideo Call Assisted Assessment of Acute Stroke | 2026-12-01 |
| NCT03160131University Hospital, Gentofte, CopenhagenRehabilitation of Visual Function After Brain Injury | 2026-12-31 |
| NCT03862859Nicholas CarlsonThe Danish Warfarin-Dialysis Study - Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis | 2027-01 |
| NCT07590726Rigshospitalet, DenmarkPIRe 2.0: A Stepped-Care Model for Involving Relatives Across Sectors | 2027-04-01 |
Add all 7 to your calendar (.ics) → With an account.
Among the 161 studies in Stroke with a site in Denmark, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Our primary aim is to investigate whether remote ischemic conditioning (RIC) as an adjunctive treatment can improve long-term recovery in acute stroke patients as an adjunct to standard treatment.
Stroke is the second-leading cause of death worldwide and a leading cause of serious, long-term disability. The most common type is acute ischemic stroke (AIS) which occurs in 85% of cases. Acute cerebral thromboembolism leads to an area of permanent damage (infarct core) in the most severely hypoperfused area and a surrounding area of impaired, yet salvageable tissue known as the "ischemic penumbra".
Intravenous alteplase (IV tPA) and endovascular treatment (EVT) are approved acute reperfusion treatments of AIS to be started within the first 4½-6 hours (in some up to 24 hours) and as soon as possible after symptom onset to prevent the evolution of the infarct core. However, reperfusion itself may paradoxically result in tissue damage (reperfusion injury) and may contribute to infarct growth. Infarct progression can continue for days following a stroke, and failure of the collateral flow is a critical factor determining infarct growth.
On the other hand, in intracerebral hemorrhage (ICH) the culprit is an eruption of blood into the brain parenchyma causing tissue destruction with a massive effect on adjacent brain tissues. Hematoma expansion as well as inflammatory pathways that are activated lead to further tissue damage, edema, and penumbral hypoperfusion. The prognosis after ICH is poor with a one-month mortality of 40%.
Novel therapeutics and neuroprotective strategies that can be started ultra-early after symptom onset are urgently needed to reduce disability in both AIS and ICH.
Ischemic conditioning is one of the most potent activators of endogenous protection against ischemia-reperfusion injury. Remote Ischemic Conditioning (RIC) can be applied as repeated short-lasting ischemia in a distant tissue that results in protection against subsequent long-lasting ischemic injury in the target organ. This protection can be applied prior to or during a prolonged ischemic event as remote ischemic pre-conditioning (RIPreC) and per-conditioning (RIPerC), respectively, or immediate after reperfusion as remote ischemic post-conditioning (RIPostC). RIC is commonly achieved by inflation of a blood pressure cuff to induce 5-minute cycles of limb ischemia alternating with 5 minutes of reperfusion.
Preclinical studies show that RIC induces a promising infarct reduction in an experimental stroke model. Results from a recent proof-of-concept study at our institution indicate that RIPerC applied during ambulance transportation as an adjunctive to in-hospital IV tPA increases brain tissue survival after one month. Furthermore, RIPerC patients had less severe neurological symptoms at admission and tended to have decreased perfusion deficits.
To-date, no serious adverse events have been documented in RIC.
RIC is a non-pharmacologic and non-invasive treatment without noticeable discomfort that has first-aid potential worldwide. However, whether combined remote ischemic per- and postconditioning can improve long-term recovery in AIS and ICH has never been investigated in a randomized controlled trial.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Remote ischemic conditioning (RIC) is applied in the hyperacute prehospital phase using an automated RIC device. Treatment characteristics: Five cycles (50 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff. The cuff pressure will be 200 mmHg; but if initial systolic blood pressure is above 175 mmHg, the cuff is automatically inflated to 35 mmHg above the systolic blood pressure. * Initial remote ischemic conditioning: prehospital phase, all included patients * Remote ischemic conditioning at +6 hours: In-hospital, only patients with AIS and ICH, all centres * Remote Ischemic Postconditioning (twice daily for 7 days): In-hospital/rehabilitation, Only patients with AIS and ICH and only at Aarhus University Hospital Usual care with or without acute reperfusion therapy
Device: Remote Ischemic Conditioning
Sham remote ischemic conditioning (Sham-RIC) is applied in the hyperacute prehospital phase using an automated Sham-RIC device. Treatment characteristics: Five cycles (50 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff. The cuff pressure will be always be 20 mmHg. * Initial Sham remote ischemic conditioning: prehospital phase, all included patients * Sham Remote ischemic conditioning at +6 hours: In-hospital, only patients with AIS and ICH, all centres * Sham Remote Ischemic Postconditioning (twice daily for 7 days): In-hospital/rehabilitation, Only patients with AIS and ICH and only at Aarhus University Hospital Usual care with or without acute reperfusion therapy.
Device: Sham Remote Ischemic Conditioning
RIC is commonly achieved by inflation of a blood pressure cuff to induce 5-minute cycles of limb ischemia alternating with 5 minutes of reperfusion.
Sham Comparator (Sham-RIC)
Modified Rankin Scale at 3 Months in Acute Stroke (AIS and ICH)
Clinical outcome (modified Rankin Scale) at 3 months in acute stroke patients (target diagnosis) (generalized ordinal logistic regression). The assessment will performed by two independent telephone or face-to-face assessors. the mRS range from 0 to 6, with higher scores representing worse outcome (mRS 0, no symptoms; mRS 6, death) If disagreement occurs the patient will be contacted by a third assessor (face-to-face or telephone) who is blinded to the intervention who will assess the level of dependency. * If disagreement occurs between two telephone assessments - a third, and final, telephone or face-to-face assessment will be made. * If disagreement occurs between one face-to-face assessment and one telephone assessment * the face-to-face will be considered the final assessment * If disagreement occurs between two face-to-face assessments - a third, and final, telephone or face-to-face assessment will be made.
Time frame: 3 months
Difference Neurological Impairment During the First 24 Hours
Neurological deficits are documented using Prehospital Stroke Score (PreSS). Prehospital Stroke Score is assessed in the the ambulance and at 24-hour or at discharge (if discharge occurs before 24 hours). The PreSS score consists of the Cincinnati Prehospital Stroke Scale (CPSS) with an additional opportunity to report other neurological symptoms (e.g. ataxia, sensory disturbances and visual field loss), and PASS (Prehospital Acute Stroke Severity Scale). The PreSS score range from 0-6, with 6 representing the most severe neurological deficits.
Time frame: 24 hours
Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Acute Ischemic Stroke
Clinical outcome (modified Rankin Scale) at 3 months in acute stroke patients (target diagnosis) (generalized ordinal logistic regression). TThe assessment will performed by two independent telephone or face-to-face assessors. the mRS range from 0 to 6, with higher scores representing worse outcome (mRS 0, no symptoms; mRS 6, death) If disagreement occurs the patient will be contacted by a third assessor (face-to-face or telephone) who is blinded to the intervention who will assess the level of dependency. If disagreement occurs between two telephone assessments - a third, and final, telephone or face-to-face assessment will be made. If disagreement occurs between one face-to-face assessment and one telephone assessment the face-to-face will be considered the final assessment If disagreement occurs between two face-to-face assessments - a third, and final, telephone or face-to-face assessment will be made.
Time frame: 3 months
Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Acute Ischemic Stroke Receiving Reperfusion Therapy
Clinical outcome (modified Rankin Scale) at 3 months inacute ischemic stroke receiving reperfusion therapy (generalized ordinal logistic regression). The assessment will performed by two independent telephone or face-to-face assessors. the mRS range from 0 to 6, with higher scores representing worse outcome (mRS 0, no symptoms; mRS 6, death) If disagreement occurs the patient will be contacted by a third assessor (face-to-face or telephone) who is blinded to the intervention who will assess the level of dependency. If disagreement occurs between two telephone assessments - a third, and final, telephone or face-to-face assessment will be made. If disagreement occurs between one face-to-face assessment and one telephone assessment the face-to-face will be considered the final assessment If disagreement occurs between two face-to-face assessments - a third, and final, telephone or face-to-face assessment will be made.
Time frame: 3 months
Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Patients With Intracerebral Hemorrhage (ICH)
Clinical outcome (modified Rankin Scale) at 3 months in patients with intracerebral hemorrhage (ICH) (generalized ordinal logistic regression). The assessment will performed by two independent telephone or face-to-face assessors. the mRS range from 0 to 6, with higher scores representing worse outcome (mRS 0, no symptoms; mRS 6, death) If disagreement occurs the patient will be contacted by a third assessor (face-to-face or telephone) who is blinded to the intervention who will assess the level of dependency. If disagreement occurs between two telephone assessments - a third, and final, telephone or face-to-face assessment will be made. If disagreement occurs between one face-to-face assessment and one telephone assessment the face-to-face will be considered the final assessment If disagreement occurs between two face-to-face assessments - a third, and final, telephone or face-to-face assessment will be made.
Time frame: 3 months
Difference in Proportion of Patients With Complete Remission of Symptoms Within 24 Hours (TIA; Both With and Without DWI)
Difference in proportion of patients with complete remission of symptoms within 24 hours (TIA; both with and without DWI) Diagnosis of TIA is documented in the electronic case report form
Time frame: 3 months
Major Adverse Cardiac and Cerebral Events (MACCE)
MACCE is defined as: Cardiovascular events (cardiovascular death, myocardial infarction, acute ischemic or hemorrhagic stroke) Cardiovascular death: Death from known cardiovascular cause or sudden death from unknown cause (no identified cause of death in medical history and/or autopsy) Acute myocardial infarction: Admission with a discharge diagnosis of ST-elevation myocardial infarction (STEMI) and non-ST elevation myocardial infarction (NSTEMI) and unstable angina pectoris (UAP) Stroke: Admission with a discharge diagnosis of acute ischemic or hemorrhagic stroke. Evaluation is performed using the Danish National Patient Register (LPR) and the DSR at two time points (6 and 15 months after the inclusion of the last patient). Diagnosis of AIS/TIA, ICH and MI (STEMI, NSTEMI, and UAP) are made according to national clinical practice guidelines.
Time frame: 3 months
Early Neurological Improvement in Acute Ischemic Stroke Patients (AIS)
Reduction in National Institute of Health Stroke Scale (NIHSS) ≥ 4 (baseline versus 24-Hour NIHSS). NIHSS range from 0 to 42, with higher scores representing worse neurological function.
Time frame: 24 hours
Early Neurological Improvement in Patients With Intracerebral Hemorrhage (ICH)
Reduction in National Institute of Health Stroke Scale (NIHSS) ≥ 4 (baseline versus 24-Hour NIHSS). NIHSS range from 0 to 42, with higher scores representing worse neurological function.
Time frame: 24 hours
Quality of Life Measures at 3 Months in AIS and ICH Patients
Quality of life (WHO-5 Well-Being Index) measures in AIS and ICH patients at 3 months
Time frame: 3 months
Bed-day Use in AIS and ICH Patients
Bed-day use, measured at 3 months, in AIS and ICH patients
Time frame: 3 months
Three-month and One-year Mortality
All-cause mortality is assessed and subdivided into cardiovascular mortality versus non-cardiovascular mortality
Time frame: 3 and 12 months
Clinical Outcome [Modified Rankin Scale (mRS) at 3 Months in Ischemic Stroke Patients and the Extended Remote Ischemic Postconditioning Protocol (Substudy at Aarhus University Hospital]
Clinical outcome \[modified Rankin Scale (mRS) at 3 months in ischemic stroke patients and the extended remote ischemic postconditioning protocol Ordinal logistic regression analysis will be performed.The assessment will performed by two independent telephone or face-to-face assessors. the mRS range from 0 to 6, with higher scores representing worse outcome (mRS 0, no symptoms; mRS 6, death) If disagreement occurs the patient will be contacted by a third assessor (face-to-face or telephone) who is blinded to the intervention who will assess the level of dependency. If disagreement occurs between two telephone assessments - a third, and final, telephone or face-to-face assessment will be made. If disagreement occurs between one face-to-face assessment and one telephone assessment the face-to-face will be considered the final assessment If disagreement occurs between two face-to-face assessments - a third, and final, telephone or face-to-face assessment will be made.
Time frame: 3 months
Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Intracerebral Hemorrhage Patients and the Extended Remote Ischemic Postconditioning Protocol (Substudy at Aarhus University Hospital)
Clinical outcome (modified Rankin Scale (mRS) at 3 months in intracerebral hemorrhage patients and the extended remote ischemic postconditioning protocol The assessment will performed by two independent telephone or face-to-face assessors. the mRS range from 0 to 6, with higher scores representing worse outcome (mRS 0, no symptoms; mRS 6, death) If disagreement occurs the patient will be contacted by a third assessor (face-to-face or telephone) who is blinded to the intervention who will assess the level of dependency. If disagreement occurs between two telephone assessments - a third, and final, telephone or face-to-face assessment will be made. If disagreement occurs between one face-to-face assessment and one telephone assessment the face-to-face will be considered the final assessment If disagreement occurs between two face-to-face assessments - a third, and final, telephone or face-to-face assessment will be made.
Time frame: 3 months
Endovascular Treatment(EVT) -Eligibility (MRI Assessed) in RIC Treated AIS Patients With Large Vessel (Substudy at Aarhus University Hospital)
Proportion of RIC treated AIS patients with large vessel occlusion (LVO) eligible to EVT treatment compared to standard treatment, adjusted for prehospital stroke severity (PreSS) and symptom duration * Severe Stroke (NIHSS ≥ 10) * Groin puncture feasible within 6 hours from stroke onset * MRI-time-of-flight (TOF) documented internal carotid artery (ICA), Intracranial ICA (ICA-T) and first and second stem of the middle cerebral artery (M1 and M2, respectively) * No contraindications to MRI (pacemaker, vomiting, respiratory insufficiency, obesity) * MRI-Diffusion weighted imaging (DWI) lesion volume ≤ 70 mL
Time frame: 6 hours
Infarct Growth in AIS Patients (Substudy at Aarhus University Hospital)
24-hour infarct growth on DWI-MRI (Difference in lesion volume between acute and 24-hour DWI-MRI) (Substudy at Aarhus University Hospital)
Time frame: 24 hour
Difference in Acute (24-hour) Hematoma Expansion in Patients With ICH (Substudy at Aarhus University Hospital)
24-hour hematoma growth (Difference in hematoma volume between acute and 24-hour CT/MRI) (Substudy at Aarhus University Hospital)
Time frame: 24 hour
Difference in 7 Days Hematoma Volume in Patients With ICH (Substudy at Aarhus University Hospital)
7-day hematoma reduction (Difference in hematoma volume between acute and 7-day (day 5 to 9) CT ) (Substudy at Aarhus University Hospital)
Time frame: 7 days
Ektacytometry and Analytical Flow Cytometry for eryNOS3 Phosphorylation
Ektacytometry for Erythrocytic Deformability and Analytical Flow Cytometry (FC) for eryNOS3 phosphorylation (pNOS3Ser1177) and s-nitrosylation (-SNO) in RBC
Time frame: 12 months
MicroRNA and Extracellular Vesicle Profile of RIC-induced Neuroprotection
MicroRNA and extracellular vesicle characterization of a possible RIC treatment profile (substudy at Aarhus University Hospital)
Time frame: 12 months
Prehospital microRNA and Extracellular Vesicles (Substudy at Aarhus University Hospital)
Diagnostic abilities of a prehospital microRNA and extracellular vesicles blood samples profile combined with prehospital stroke severity on the differentiation of hemorrhagic from ischemic stroke and to grade ischemic stroke severity
Time frame: 12 months
Prehospital Glial Fibrillary Acidic Protein (Substudy at Aarhus University Hospital)
Predictive abilities of Glial Fibrillary Acidic Protein (GFAP) in prehospital obtained blood samples combined with prehospital stroke severity to differentiate hemorrhagic from ischemic stroke and to grade ischemic stroke severity
Time frame: 12 months
Coagulation Profile of Putative Stroke Patients in Prehospital Obtained Blood Samples
Functional and immunologic plasma assays will be employed to analyze proteins and pathways in coagulation and fibrinolysis (substudy at Aarhus University Hospital)
Time frame: 12 months
| Milestone | Remote Ischemic Condtioning (RIC) | Sham Remote Ischemic Conditioning |
|---|---|---|
| Started | 749 | 751 |
| Completed | 436 | 466 |
| Not completed | 313 | 285 |
| Withdrew: Withdrawal by subject | 36 | 31 |
| Withdrew: Non stroke = non target population | 277 | 254 |
Clinical outcome (modified Rankin Scale) at 3 months in acute stroke patients (target diagnosis) (generalized ordinal logistic regression). The assessment will performed by two independent telephone or face-to-face assessors. the mRS range from 0 to 6, with higher scores representing worse outcome (mRS 0, no symptoms; mRS 6, death) If disagreement occurs the patient will be contacted by a third assessor (face-to-face or telephone) who is blinded to the intervention who will assess the level of dependency. * If disagreement occurs between two telephone assessments - a third, and final, telephone or face-to-face assessment will be made. * If disagreement occurs between one face-to-face assessment and one telephone assessment * the face-to-face will be considered the final assessment * If disagreement occurs between two face-to-face assessments - a third, and final, telephone or face-to-face assessment will be made.
| units on a scale | Remote Ischemic Conditioning (RIC) | Sham |
|---|---|---|
| Modified Rankin Scale at 3 Months in Acute Stroke (AIS and ICH) | 2 (1 to 3) | 1 (1 to 3) |
Neurological deficits are documented using Prehospital Stroke Score (PreSS). Prehospital Stroke Score is assessed in the the ambulance and at 24-hour or at discharge (if discharge occurs before 24 hours). The PreSS score consists of the Cincinnati Prehospital Stroke Scale (CPSS) with an additional opportunity to report other neurological symptoms (e.g. ataxia, sensory disturbances and visual field loss), and PASS (Prehospital Acute Stroke Severity Scale). The PreSS score range from 0-6, with 6 representing the most severe neurological deficits.
| units on a scale | Remote Ischemic Conditioning | Sham - Remote Ischemic Conditioning |
|---|---|---|
| Difference Neurological Impairment During the First 24 Hours | -1 (-2 to 0) | -2 (-2 to 0) |
Clinical outcome (modified Rankin Scale) at 3 months in acute stroke patients (target diagnosis) (generalized ordinal logistic regression). TThe assessment will performed by two independent telephone or face-to-face assessors. the mRS range from 0 to 6, with higher scores representing worse outcome (mRS 0, no symptoms; mRS 6, death) If disagreement occurs the patient will be contacted by a third assessor (face-to-face or telephone) who is blinded to the intervention who will assess the level of dependency. If disagreement occurs between two telephone assessments - a third, and final, telephone or face-to-face assessment will be made. If disagreement occurs between one face-to-face assessment and one telephone assessment the face-to-face will be considered the final assessment If disagreement occurs between two face-to-face assessments - a third, and final, telephone or face-to-face assessment will be made.
| units on a scale | Remote Ischemic Conditioning (RIC) | Sham |
|---|---|---|
| Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Acute Ischemic Stroke | 1 (1 to 2) | 1 (0 to 3) |
Clinical outcome (modified Rankin Scale) at 3 months inacute ischemic stroke receiving reperfusion therapy (generalized ordinal logistic regression). The assessment will performed by two independent telephone or face-to-face assessors. the mRS range from 0 to 6, with higher scores representing worse outcome (mRS 0, no symptoms; mRS 6, death) If disagreement occurs the patient will be contacted by a third assessor (face-to-face or telephone) who is blinded to the intervention who will assess the level of dependency. If disagreement occurs between two telephone assessments - a third, and final, telephone or face-to-face assessment will be made. If disagreement occurs between one face-to-face assessment and one telephone assessment the face-to-face will be considered the final assessment If disagreement occurs between two face-to-face assessments - a third, and final, telephone or face-to-face assessment will be made.
| units on a scale | Remote Ischemic Conditioning (RIC) | Sham |
|---|---|---|
| Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Acute Ischemic Stroke Receiving Reperfusion Therapy | 1 (1 to 3) | 1 (1 to 3) |
Clinical outcome (modified Rankin Scale) at 3 months in patients with intracerebral hemorrhage (ICH) (generalized ordinal logistic regression). The assessment will performed by two independent telephone or face-to-face assessors. the mRS range from 0 to 6, with higher scores representing worse outcome (mRS 0, no symptoms; mRS 6, death) If disagreement occurs the patient will be contacted by a third assessor (face-to-face or telephone) who is blinded to the intervention who will assess the level of dependency. If disagreement occurs between two telephone assessments - a third, and final, telephone or face-to-face assessment will be made. If disagreement occurs between one face-to-face assessment and one telephone assessment the face-to-face will be considered the final assessment If disagreement occurs between two face-to-face assessments - a third, and final, telephone or face-to-face assessment will be made.
| units on a scale | Remote Ischemic Conditioning (RIC) | Sham |
|---|---|---|
| Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Patients With Intracerebral Hemorrhage (ICH) | 3 (2 to 5) | 3 (2 to 5) |
Difference in proportion of patients with complete remission of symptoms within 24 hours (TIA; both with and without DWI) Diagnosis of TIA is documented in the electronic case report form
| Participants | Remote Ischemic Conditioning (RIC) | Sham |
|---|---|---|
| Difference in Proportion of Patients With Complete Remission of Symptoms Within 24 Hours (TIA; Both With and Without DWI) | 96 | 90 |
MACCE is defined as: Cardiovascular events (cardiovascular death, myocardial infarction, acute ischemic or hemorrhagic stroke) Cardiovascular death: Death from known cardiovascular cause or sudden death from unknown cause (no identified cause of death in medical history and/or autopsy) Acute myocardial infarction: Admission with a discharge diagnosis of ST-elevation myocardial infarction (STEMI) and non-ST elevation myocardial infarction (NSTEMI) and unstable angina pectoris (UAP) Stroke: Admission with a discharge diagnosis of acute ischemic or hemorrhagic stroke. Evaluation is performed using the Danish National Patient Register (LPR) and the DSR at two time points (6 and 15 months after the inclusion of the last patient). Diagnosis of AIS/TIA, ICH and MI (STEMI, NSTEMI, and UAP) are made according to national clinical practice guidelines.
| Participants | Remote Ischemic Conditioning (RIC) | Sham |
|---|---|---|
| Major Adverse Cardiac and Cerebral Events (MACCE) | 57 | 62 |
Reduction in National Institute of Health Stroke Scale (NIHSS) ≥ 4 (baseline versus 24-Hour NIHSS). NIHSS range from 0 to 42, with higher scores representing worse neurological function.
| Participants | Remote Ischemic Conditioning (RIC) | Sham |
|---|---|---|
| Early Neurological Improvement in Acute Ischemic Stroke Patients (AIS) | 108 | 131 |
Reduction in National Institute of Health Stroke Scale (NIHSS) ≥ 4 (baseline versus 24-Hour NIHSS). NIHSS range from 0 to 42, with higher scores representing worse neurological function.
Results for this outcome have not been posted.
Quality of life (WHO-5 Well-Being Index) measures in AIS and ICH patients at 3 months
Results for this outcome have not been posted.
Bed-day use, measured at 3 months, in AIS and ICH patients
Results for this outcome have not been posted.
All-cause mortality is assessed and subdivided into cardiovascular mortality versus non-cardiovascular mortality
Results for this outcome have not been posted.
Clinical outcome \[modified Rankin Scale (mRS) at 3 months in ischemic stroke patients and the extended remote ischemic postconditioning protocol Ordinal logistic regression analysis will be performed.The assessment will performed by two independent telephone or face-to-face assessors. the mRS range from 0 to 6, with higher scores representing worse outcome (mRS 0, no symptoms; mRS 6, death) If disagreement occurs the patient will be contacted by a third assessor (face-to-face or telephone) who is blinded to the intervention who will assess the level of dependency. If disagreement occurs between two telephone assessments - a third, and final, telephone or face-to-face assessment will be made. If disagreement occurs between one face-to-face assessment and one telephone assessment the face-to-face will be considered the final assessment If disagreement occurs between two face-to-face assessments - a third, and final, telephone or face-to-face assessment will be made.
Results for this outcome have not been posted.
Clinical outcome (modified Rankin Scale (mRS) at 3 months in intracerebral hemorrhage patients and the extended remote ischemic postconditioning protocol The assessment will performed by two independent telephone or face-to-face assessors. the mRS range from 0 to 6, with higher scores representing worse outcome (mRS 0, no symptoms; mRS 6, death) If disagreement occurs the patient will be contacted by a third assessor (face-to-face or telephone) who is blinded to the intervention who will assess the level of dependency. If disagreement occurs between two telephone assessments - a third, and final, telephone or face-to-face assessment will be made. If disagreement occurs between one face-to-face assessment and one telephone assessment the face-to-face will be considered the final assessment If disagreement occurs between two face-to-face assessments - a third, and final, telephone or face-to-face assessment will be made.
Results for this outcome have not been posted.
Proportion of RIC treated AIS patients with large vessel occlusion (LVO) eligible to EVT treatment compared to standard treatment, adjusted for prehospital stroke severity (PreSS) and symptom duration * Severe Stroke (NIHSS ≥ 10) * Groin puncture feasible within 6 hours from stroke onset * MRI-time-of-flight (TOF) documented internal carotid artery (ICA), Intracranial ICA (ICA-T) and first and second stem of the middle cerebral artery (M1 and M2, respectively) * No contraindications to MRI (pacemaker, vomiting, respiratory insufficiency, obesity) * MRI-Diffusion weighted imaging (DWI) lesion volume ≤ 70 mL
Results for this outcome have not been posted.
24-hour infarct growth on DWI-MRI (Difference in lesion volume between acute and 24-hour DWI-MRI) (Substudy at Aarhus University Hospital)
Results for this outcome have not been posted.
24-hour hematoma growth (Difference in hematoma volume between acute and 24-hour CT/MRI) (Substudy at Aarhus University Hospital)
Results for this outcome have not been posted.
7-day hematoma reduction (Difference in hematoma volume between acute and 7-day (day 5 to 9) CT ) (Substudy at Aarhus University Hospital)
Results for this outcome have not been posted.
Ektacytometry for Erythrocytic Deformability and Analytical Flow Cytometry (FC) for eryNOS3 phosphorylation (pNOS3Ser1177) and s-nitrosylation (-SNO) in RBC
Results for this outcome have not been posted.
MicroRNA and extracellular vesicle characterization of a possible RIC treatment profile (substudy at Aarhus University Hospital)
Results for this outcome have not been posted.
Diagnostic abilities of a prehospital microRNA and extracellular vesicles blood samples profile combined with prehospital stroke severity on the differentiation of hemorrhagic from ischemic stroke and to grade ischemic stroke severity
Results for this outcome have not been posted.
Predictive abilities of Glial Fibrillary Acidic Protein (GFAP) in prehospital obtained blood samples combined with prehospital stroke severity to differentiate hemorrhagic from ischemic stroke and to grade ischemic stroke severity
Results for this outcome have not been posted.
Functional and immunologic plasma assays will be employed to analyze proteins and pathways in coagulation and fibrinolysis (substudy at Aarhus University Hospital)
Results for this outcome have not been posted.
Collected over 90 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Remote Ischemic Conditioning (RIC) | 41/713 (5.8%) | 335/713 (47%) | 54/713 (7.6%) |
| Sham | 47/720 (6.5%) | 325/720 (45.1%) | 11/720 (1.5%) |
| Event | Remote Ischemic Conditioning (RIC) | Sham |
|---|---|---|
| SAECardiac disorders | 335/713 | 325/720 |
| Event | Remote Ischemic Conditioning (RIC) | Sham |
|---|---|---|
| Upper extremity pain during treatment and/or skin petechiaMusculoskeletal and connective tissue disorders | 54/713 | 11/720 |
| Age, Continuous(years) | Remote Ischemic Conditioning | Sham | Total |
|---|---|---|---|
| Median | 72 (62 to 79) | 73 (62 to 80) | 73 (62 to 79) |
| Sex: Female, Male(Participants) | Remote Ischemic Conditioning | Sham | Total |
|---|---|---|---|
| Female | 165 | 170 | 335 |
| Male | 271 | 296 | 567 |
| Race and Ethnicity Not Collected(Participants) | Remote Ischemic Conditioning | Sham | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Remote Ischemic Conditioning | Sham | Total |
|---|---|---|---|
| Denmark | 436 | 466 | 902 |
| National Institutes of Health Stroke Scale (NIHSS)(points on NIHSS) | Remote Ischemic Conditioning | Sham | Total |
|---|---|---|---|
| Median | 5 (2 to 11) | 5 (2 to 10) | 5 (2 to 10) |
| Diagnosis(Participants) | Remote Ischemic Conditioning | Sham | Total |
|---|---|---|---|
| Acute ischemic stroke | 349 | 388 | 737 |
| Intracerebral hemorrhage | 87 | 78 | 165 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Individual participant data that underlie the results reported in this article after deidentification
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Beginning 3 months and ending 5 years following arcticle publication
Access criteria: Proprosals should be directed to rolfblau@rm.dk. To gain access data requestors will need to sign a data processing agreement.
Ran from Mar 2018 to primary completion in Feb 2023, 58 months.
Results were first posted in Jan 2025, 1 year 11 months after primary completion.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 58 months is above that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Grethe Andersen