Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion: A Randomized Controlled Pilot Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this clinical trial is to determine if direct ischemic post-conditioning (IPostC) can alleviate ischemic-reperfusion injury (I/R) in patients who have undergone endovascular thrombectomy (EVT). Additionally, the study aims to explore the underlying mechanisms of direct IPostC. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Ischemic stroke confirmed by CT or MRI.

• 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.

Locations
Other Locations
China
Tianjin Huanhu Hospital
RECRUITING
Tianjin
Contact Information
Primary
Ming Wei, MD, PhD
drweiming@163.com
13502182903
Backup
Yongbo Xu, MD
yonbur@outlook.com
17361616533
Time Frame
Start Date: 2023-02-05
Estimated Completion Date: 2024-09
Participants
Target number of participants: 60
Treatments
Active_comparator: Endovascular therapy
Experimental: Endovascular therapy plus direct ischemic post-conditioning
Related Therapeutic Areas
Sponsors
Leads: Tianjin Huanhu Hospital

This content was sourced from clinicaltrials.gov

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