An observational study in Ischemic Stroke and Transient Ischemic Attack, sponsored by VASCage GmbH. Active, not recruiting at 2 sites in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by VASCage GmbH · Observational
Stroke is the second leading cause of death and one of the main contributors to disability. Patients who survive the acute phase of ischemic stroke and those with transient ischemic attack (TIA) are at high risk of subsequent vascular events. Importantly, recurrent strokes are associated with a higher social and economic impact, higher case fatality, and worse clinical outcome than first-ever strokes. The burden of post-stroke complications, residual deficits, and inadequate medical and psychosocial care all contribute to long-term disability and reduced quality of life in these patients. The Department of Neurology of the Medical University Innsbruck undertook the STROKE-CARD trial (NCT02156778) between 2014 and 2018 with follow-up until 2019 to evaluate the efficacy of the Post-Stroke disease-management program STROKE-CARD care. After implementation of STROKE-CARD care, the investigators aim to document the quality of post-stroke care and compare outcome parameters to historical cohorts and the change over time. Furthermore the investigators aim to gain a large data-resource for future research of biomarkers, disease mechanisms, prognosis and imaging mechanisms for R\&D.
Stroke is the second leading cause of death and one of the main contributors to disability. Patients who survive the acute phase of ischemic stroke and those with a transient ischemic attack (TIA) are at high risk of subsequent stroke. Importantly, recurrent strokes are associated with a higher social and economic impact, higher case fatality, and worse clinical outcome than first-ever strokes. The burden of post-stroke complications, residual deficits, and inadequate medical and psychosocial care all contribute to long-term disability and reduced quality of life in these patients. Furthermore, effects on quality of life and long-term functional independence are particularly under-investigated.
The Department of Neurology of the Medical University Innsbruck undertook the STROKE-CARD trial (NCT02156778) between 2014 and 2018 with follow-up until 2019 to evaluate the efficacy of the Post-Stroke disease management program STROKE-CARD care. The aim is to evaluate this program in a large multicenter cohort and to establish a biobank of stroke and TIA-patients for future research and development projects.
In brief, the pragmatic and easily implementable STROKE-CARD care program reduced cardiovascular risk and improved health-related quality of life and functional outcome in patients with acute ischemic stroke or TIA in a timeframe of 12 months after the index event. To investigate the effects of STROKE-CARD care on a large basis and over a longer period, an evaluation of approximately 5,000 patients is warranted.
Whereas disease management programs typically rely on expert opinion, the STROKE-CARD initiative moved from a purely empirical approach to a highly structured, individualized, and evidence-based procedure with professional outcome analysis. The STROKE-CARD concept will be implemented in clinical practice and can serve as a model for other disease management initiatives.
Acute and short-term management of stroke and TIA has improved tremendously over the past years with substantial advances in acute therapy, implementation of comprehensive pathways for stroke and TIA, and approval of novel highly effective preventive treatments. As a main unmet challenge in stroke medicine, strategies of long-term care have to be developed and rigorously tested in order to maintain improved short-term patient outcome in the long run.
STROKE-CARD care reduced the one-year cumulative absolute risk of CVD and ameliorated the patients' health-related quality of life at 12 months (EQ-5D-3L overall utility score, P\<0.001). These findings were consistent in subgroups according to age, sex, and index event and were robust in the per-protocol analysis. Among pre-specified secondary outcomes assessed at 12 months, the investigators observed improvements in all individual dimensions of the EQ-5D-3L and in one-year functional outcome, that each met the multiplicity-adjusted threshold for statistical significance. Only a few previous trials of disease management programs in stroke and TIA patients have focused on recurrent CVD or quality of life as primary or secondary endpoints and none has considered long-term functional outcome after one year. The previous trial was limited to a 12-month follow-up in selected individuals and the sustainability of benefits of STROKE-CARD care in a large nationwide cohort over a longer follow-up period remains to be determined.
This study aims to detect post-stroke complications, to estimate the patient's demand for nursing services, and support guideline-compliant secondary prevention with full achievement of target levels, lifestyle modifications, and in-person outcome assessment at 3 and 12 months after the index-event, assessment of functional status (impairment), activity (disability), and participation (handicap and health-related quality of life). Additionally, yearly follow-up telephone interviews for cardiovascular outcome and health parameters will be conducted. In case of clinically indicated in-person follow-ups, the interviews will be done in person during the clinical visits. After the implementation of STROKE-CARD care, the investigators aim to document the quality of post-stroke care and compare outcome parameters to historical cohorts and the change over time. Furthermore, the investigators aim to gain a large data resource for future research of biomarkers, disease mechanisms, prognosis and imaging mechanisms for R\&D.
The main objective is to evaluate the Post-Stroke Disease Management program STROKE-CARD in a large multicenter cohort of stroke and TIA-patients and to establish a large clinical well-defined cohort. Furthermore, the investigators aim to gain a large data resource for future research of biomarkers, disease mechanisms, prognosis and imaging mechanisms for R\&D.
To document and monitor the quality of the Post-Stroke Disease Management program in different centers and compare outcomes to the historical cohort, as well as other published data. Furthermore, the investigators aim to constantly improve post-stroke care. This registry can facilitate to monitor and document the effect on the primary and secondary outcomes.
There will be no formal safety endpoints in this study. No experimental procedures will be applied to patients and most of the procedures done are within the clinical routine. Potential side effects of optimal secondary stroke prevention are recorded.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 300 across 771 observational studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →VASCage GmbH is the lead sponsor of 12 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with acute ischemic stroke or high-risk TIA (ABCD2-Score ≥ 4 points) in the last 30 days over 18 years of age will be invited to the study at all study centers in the designated departments.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
N/A - Observational Study
CVD outcome
CVD outcome defined as nonfatal ischemic stroke, nonfatal hemorrhagic stroke, nonfatal myocardial infarction, or vascular death between hospital discharge and one year in an in-person follow-up and yearly for up to 6 years.
Time frame: 1-7 years
Health-related quality of life: scale
Self-reported health-related quality of life after one year in an in-person follow-up and yearly for up to 6 years using a telephone-based follow-up quantified with the European Quality of Life 5-Dimensions 3-Levels (EQ-5D-3L) overall health utility score14 with rescaled European visual analogue scale weights.
Time frame: 1-7 years
Composite stroke event outcome
Composite outcome of ischemic stroke, hemorrhagic stroke, or transient ischemic attack (TIA) (defined as transient neurological deficit \<24h and absence of diffusion-weighted imaging (DWI) positive lesions on MRI) after one year and on the long run
Time frame: 1-7 years
All-cause mortality
All-cause mortality after one year and in the long run
Time frame: 1-7 years
Individual 3-level components of the European Quality of Life 5-Dimensions 3-Levels (EQ-5D-3L) questionnaire
Mobility, self-care, usual activities, no pain or discomfort, no anxiety or depression) comparing people reporting no problems (level 1) with those reporting problems (level 2 and 3) after one year in an in-person follow-up and in the long run
Time frame: 1-7 years
Proportions of participants achieving target levels of risk factors
* systolic blood pressure \<140 mmHg and a diastolic blood pressure \<90 mmHg or a systolic blood pressure \<130 mmHg and a diastolic blood pressure \<85 mmHg at the study visit in patients with diabetes mellitus, severe renal impairment, or small-vessel disease at baseline, * achieving a glycated hemoglobin (HbA1c) concentration \<7.0% in patients with diabetes mellitus or \<8% in selected individuals * having quit smoking after one year and on the long run * being physically active for an average of \>90 minutes/week * taking lipid-lowering medication in all patients except those with an event of other determined etiology (e.g. due to vasculitis or vessel dissection) * achieving a low-density lipoprotein (LDL) cholesterol concentration \<70 mg/dL * taking anticoagulation or antiplatelet therapy in patients that had been prescribed such medication * taking anticoagulation in patients with atrial fibrillation after one year and in the long run
Time frame: 1-7 years
Functional outcome
Good functional outcome defined as modified Rankin Scale25 (mRS) ≤2 after one year and in the long run Distribution across mRS categories after one year and in the long run ("shift analysis")
Time frame: 1-7 years
Plan to share: Undecided
Started Dec 2020 (actual). Primary completion is estimated for Mar 2027, 75 months after the start.
Of 394 non-industry observational studies under Ischemic Stroke, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 140. This study's planned 75 months is above that.
Counting every sponsor, half of 436 studies reached it within 53 months; a quarter within 24 and three quarters within 127.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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VASCage GmbH