Actively Recruiting
Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion: A Randomized Controlled Pilot Trial
Led by Tianjin Huanhu Hospital · Updated on 2024-08-09
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether direct ischemic post-conditioning (IPostC) can reduce ischemic-reperfusion injury in patients who have had an endovascular thrombectomy (EVT) for acute stroke caused by large vessel occlusion. The trial also explores the biological mechanisms behind direct IPostC. The main questions are whether direct IPostC is effective for these stroke patients and how it works biologically. Participants are randomly assigned to one of two groups: EVT alone or EVT combined with direct ischemic post-conditioning. The direct IPostC procedure involves inflating a balloon at the occlusion site after thrombectomy to block blood flow for 2 minutes, then deflating it to restore flow for 2 minutes, repeated four times. This treatment is given immediately after EVT. During the study, researchers will measure final infarct volume and infarct volume growth within about 24 hours after the procedure. Additional assessments include changes in neurological function shortly after treatment, functional independence at 5 and 90 days, and blood-brain barrier permeability. The study also includes imaging and laboratory tests to monitor ischemia-reperfusion injury and a multi-omics analysis to understand detailed mechanisms. Participation involves these evaluations and monitoring over several days to months after treatment.
CONDITIONS
Brief Title
Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ischemic stroke confirmed by CT or MRI
- Large vessel occlusion confirmed by CTA or MRA, including intracranial internal carotid artery and middle cerebral artery (M1/M2)
- Recanalization of the occluded vessel at eTICI grade 2b/3 confirmed by DSA after thrombectomy
- Signed informed consent by patient or legally authorized representative
- Age 18 years or older
You will not qualify if you...
- Inability to perform MRI or CT scan
- Conditions interfering with neurological assessment or psychiatric disorders
- Stroke onset with seizures preventing accurate NIHSS baseline
- Pregnancy
- Other serious, advanced, or terminal illnesses
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Procedure day and up to 5 days or discharge
Participants undergo endovascular therapy (thrombectomy) with or without direct ischemic post-conditioning, which involves repeated balloon inflation to block and restore blood flow at the occlusion site.
1 procedure visit and up to 1 follow-up visit within 5 days or at discharge
Duration - Up to 90 days after randomization
Participants are monitored for functional independence and neurological changes up to 90 days after the procedure.
Visits at 2 hours, 24 hours, 72 hours, 5 days or at discharge, and 90 days after randomization
Trial Site Locations
Total: 1 location
1
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China, 300070
Actively Recruiting
Research Team
M
Ming Wei, MD, PhD
Y
Yongbo Xu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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