ClinicalTrials.gg
RecruitingNCT06665386Updated Dec 12, 2024

Prognostic Biomarkers for Selective Intra-Arterial Cooling Infusion Combined with Endovascular Thrombectomy in Acute Ischemic Stroke Based on Proteomics and Metabolomics.

An observational study in Stroke and Hypothermia Treatment, sponsored by Capital Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-12.

Sponsored by Capital Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
  • Started Oct 2024; still recruiting 2 years later.

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
258
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 33 studies in Stroke by Capital Medical University — 7 open to participants now, 10 under way, 3 of them phase 3. Stroke · Capital Medical University.

Started
2024
with 3 others
Observational
5 of 33
2 open now
Registered
24th of 33
by date

Among the 33 studies in Stroke by Capital Medical University, this one is one of 4 that started in 2024, is one of 5 observational ones, and was the 24th registered.

Stroke

8,258 studies on the registry are indexed under Stroke; 2,055 are open to participants now.

Browse Stroke studies →

Open to participants now

7 of the 33 studies in Stroke by Capital Medical University are open now, in 1 country. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 7 open studies →

Where they have run

Who these studies take

Of the 1,415 Stroke studies recruiting now, 695 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 195 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 33 studies in Stroke by Capital Medical University, or all of them as a file.
02

Study summary

Endovascular Thrombectomy has emerged as a pivotal treatment modality for acute ischemic stroke. However, despite successful thrombus removal, a substantial proportion of patients still experience poor outcomes. Selective intra-arterial cooling has shown promise in decelerating stroke progression and providing neuroprotection. This study aims to identify biomarkers associated with the combination of selective intra-arterial cooling infusion and endovascular thrombectomy in the treatment of ischemic stroke by integrating proteomics and metabolomics data. Our study is based on the multicenter RCT study "Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With EVT in Acute Ischemic Stroke." All samples were derived from this experiment. Our objective is to elucidate the molecular mechanisms underlying the prognostic impact of this combined therapeutic approach, providing insights to optimize stroke treatment strategies.

03

Conditions studied

  • Stroke
  • Hypothermia Treatment

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04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Blood samples were collected from patients who underwent Endovascular Thrombectomy alone and those who received selective intra-arterial cooling infusion combined with Endovascular Thrombectomy. The supernatant was separated by centrifugation and stored in a -80°C refrigerator.

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.

Inclusion criteria

  • Age ≥18 and ≤80.
  • Clinical signs consistent with acute ischemic stroke with large vessel occlusion in the anterior circulation (intracranial segment of the internal carotid artery, middle cerebral artery M1 segment) demonstrated with CTA/MRA/DSA.
  • NIHSS score obtained prior to randomization ≥6 and ≤25.
  • Modified Rankin Scale ≤ 1 prior to qualifying stroke.
  • Arterial puncture performed within 24 hours from symptom onset or LKW.
  • For the patients with symptom onset within 6 hours, the ASPECT score ≥6; for the patientswith onset within 6-24 hours, the therapy should meet the imaging criteria of DAWN or DEFUSE-3 trial.
  • Patient/Legally Authorized Representative has signed the Form.

Exclusion criteria

Exclusion Criteria:

  • Baseline CT/MRI confirms the presence of multiple vascular territory acute strokes.
  • Baseline CT/MRI confirms the presence of arterial dissection.
  • Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy.
  • Known allergies or intolerances to antiplatelet agents, anticoagulation drugs, iodinated contrast and/or anesthetics.
  • Severe infection (e.g. sepsis) or multiple organ failure.
  • Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with > 3. Patients on factor Xa inhibitor for 48 hours ago must have a normal APTT.
  • Baseline count \<50 × 109/L.
  • Blood glucose concentration\<50 mg/dL (2.7mmol/L) or >400 mg/dL (22.2mmol/L).
  • hypertension that is difficult to control by medication (Defined as persistent systolic blood pressure>185 mmHg or diastolic blood pressure>110mmHg).
  • Previous NHYA>1.
  • Untreated moderate or severe coronary artery stenosis, or previous coronary artery bypass surgery.
  • Undergoing hemodialysis or peritoneal dialysis; known severe renal insufficiency with \<30 ml/min or serum creatinine >220 mmol/L (2.5mg/dl).
  • Known intracranial aneurysm, and cerebral arteriovenous malformation.
  • Malignant brain tumor or CNS infection.
  • Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations (e.g., dementia or mental illness)
  • Female who is pregnant or lactating at time of admission.
  • Anticipated \<6 months.
  • Current participation in another drug or device study.
  • For other reasons, the responsible clinicians believe that the patient is not suitable for continued treatment.
Terms in these criteria, in plain language(7)

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.

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.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
258 participants (estimated)
Patient registry
No

Groups and cohorts

  • Control Group

    Patients will receive best medical management (BMM) plus EVT according to the clinical guidelines.

  • IA-SCI group

    Patients will receive BMM and EVT combined with selective intra-arterial cold saline infusion.

    Procedure: hypothermia

Interventions

  • Procedurehypothermia

    Patients who meet the inclusion criteria and do not meet the exclusion criteria will be randomly assigned to either the control group or the IA-SCI group. Control group patients will receive BMM and EVT. IA-SCI group patients will receive BMM and EVT, and additionally a selective intraarterial cooling infusion. The specific method is as follows: * Pre-recanalization: During the procedure, a micro-catheter used to deploy the stent retriever is threaded coaxially into the common femoral artery through the guide catheter. The microcatheter is advanced over a microguide wire, traveling up through the neck until it reaches beyond the clot. A 50 mL cold 0.9% saline (4℃) is infused into the ischemic territory at a rate of 10 mL/min via the microcatheter. This enables the cold solution to infuse into the ischemic territory prior to revascularization. * Post-recanalization: Following vessel recanalization, cold 0.9% saline (4 ℃) is reinfused into the vessel via the catheter at a rate of 22 mL

06

What researchers measure

Primary outcomes

  1. Primary Outcome

    Prognostic Biomarkers for Selective Intra-Arterial Cooling Infusion Combined with Endovascular Thrombectomy in Acute Ischemic Stroke Based on Proteomics and Metabolomics. Measure Description: By integrating proteomics and metabolomics data, researchers were able to identify common pathways and mechanisms through which selective intra-arterial cooling infusion combined with endovascular thrombectomy influences the prognosis of ischemic stroke. Time Frame:3 months

    Time frame: 2024-10-2025-2

Secondary outcomes

  1. Secondary Outcome

    1. Quantitative changes of individual metabolites and proteins were calculated and graphed using the KEGG mapping tools. 2. All of the omics data were used to compare proteins/enzymes with metabolic pathways. 3. By integrating proteomics and metabolomics data, researchers were able to identify common pathways and mechanisms through which selective intra-arterial cooling infusion combined with endovascular thrombectomy influences the prognosis of ischemic stroke. Time Frame:3 months

    Time frame: 2024-10-2025-2

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2024 (actual). Primary completion is estimated for Feb 2025, 4 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 28, 2024
First posted
Oct 30, 2024
StartActual
Oct 27, 2024
Primary completionEst.
Feb 28, 2025
CompletionEst.
Feb 28, 2025
Last update
Dec 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06665386
Responsible party
Ji Xunming,MD,PhD (MD.PhD, Capital Medical University) — Principal investigator
First posted
Oct 30, 2024
Start date
Oct 27, 2024
Primary completion
Feb 28, 2025 (estimated)
Completion
Feb 28, 2025 (estimated)
Last update
Dec 12, 2024

Study contacts

Xunming Ji, Professor
Contact
chenxi00cx@126.com
+86 17600104266

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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