Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion
NCT ID: NCT06545734
Last Updated: 2024-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2023-02-05
2024-09-30
Brief Summary
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The primary questions this trial seeks to answer are:
1. Is direct IPostC effective for acute stroke patients with large vessel occlusion?
2. What are the underlying mechanisms of direct IPostC?
Participants will be randomly assigned to one of two groups: an EVT alone group or an EVT plus direct IPostC group. Direct IPostC will be administered immediately after EVT through four cycles of mechanical interruptions of reperfusion. We will evaluate outcomes based on final infarct volume, infarct volume growth, clinical parameters, and I/R-related imaging and laboratory biomarkers. Additionally, an exploratory multi-omics analysis will be conducted to uncover the detailed mechanisms of direct IPostC.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Endovascular therapy
Endovascular therapy
Thrombectomy alone.
Endovascular therapy plus direct ischemic post-conditioning
Direct Ischemic Post-conditioning
After thrombectomy, the balloon was inflated to a pressure of no more than 4 atm at the occlusion site to block blood flow for 2 minutes, as confirmed by angiography. The balloon was then deflated, allowing blood flow to resume for 2 minutes. These steps were repeated four times.
Endovascular therapy
Thrombectomy alone.
Interventions
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Direct Ischemic Post-conditioning
After thrombectomy, the balloon was inflated to a pressure of no more than 4 atm at the occlusion site to block blood flow for 2 minutes, as confirmed by angiography. The balloon was then deflated, allowing blood flow to resume for 2 minutes. These steps were repeated four times.
Endovascular therapy
Thrombectomy alone.
Eligibility Criteria
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Inclusion Criteria
2. Large vessel occlusion confirmed by CTA or MRA, including the intracranial internal 3. carotid artery (ICA) and middle cerebral artery (MCA M1/M2).
4\. Recanalization of the occluded vessel at eTICI grade 2b/3, confirmed by DSA after thrombectomy.
5\. The patient or legally authorized representative has signed an informed consent form.
Exclusion Criteria
2. Presence of any condition that would interfere with neurological assessment or any psychiatric disorders.
3. Stroke onset accompanied by seizures, resulting in the inability to obtain an accurate NIHSS baseline.
4. Pregnancy.
5. Presence of other serious, advanced, or terminal illnesses.
18 Years
ALL
Yes
Sponsors
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Tianjin Huanhu Hospital
OTHER
Responsible Party
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Ming Wei
Chief Physician
Locations
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Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TJHH-2024-WM28
Identifier Type: -
Identifier Source: org_study_id
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