Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion

Phase 2

Recruiting

• Conditions: Ischemic Conditioning; Stroke, Acute; Neuroprotection
• Interventions: Procedure: Endovascular therapy; Procedure: Direct Ischemic Post-conditioning

• Registration Number: NCT06545734
• Lead Sponsor: Tianjin Huanhu Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-05
• Status Verified: 2024-08
• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-08
• Last Update Submitted: 2024-08-08
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Ischemic stroke confirmed by CT or MRI.

2. Large vessel occlusion confirmed by CTA or MRA, including the intracranial internal 3. carotid artery (ICA) and middle cerebral artery (MCA M1/M2).

3. Recanalization of the occluded vessel at eTICI grade 2b/3, confirmed by DSA after thrombectomy.

4. The patient or legally authorized representative has signed an informed consent form.

Exclusion Criteria

1. Inability to perform an MRI or CT scan for any reason.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endovascular therapy	Endovascular therapy	-
Endovascular therapy plus direct ischemic post-conditioning	Direct Ischemic Post-conditioning	-
Endovascular therapy plus direct ischemic post-conditioning	Endovascular therapy	-

Primary Outcome Measures

Name	Time	Method
Final Infarct volume	24(-6/+12) hours after procedure	Infarct volume at 24 (-6/+12) hours postoperatively
Infarct Volume Growth	24(-6/+12) hours after procedure	Infarct volume at 24 (-6/+12) hours - Infarct volume at baseline; Infarct volume at 24 (-6/+12) hours - Infarct volume at 2 hours

Secondary Outcome Measures

Name	Time	Method
Functional Independence at 90 days	90 days after randomization	The proportion of mRS 0-2 at 90 days
Change in NIHSS between baseline and 2 hours	2 hours after procedure	NIHSS at 2 hours - NIHSS at baseline
Change in NIHSS between baseline and 24 hours	24 hours after procedure	NIHSS at 24 hours - NIHSS at baseline
Blood brain barrier permeability at 72 hours	72 hours after procedure	This is quantified by ktrans value through MR
Functional Independence at 5 days or discharge	5 days or at discharge after randomization	The proportion of mRS 0-2 at 5 days or discharge

Trial Locations

Locations (1)

Tianjin Huanhu Hospital; 🇨🇳 Tianjin, Tianjin, China