Effect of Ischemic Post-conditioning on Infarct Volume in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy

Capital Medical University1 site in 1 country20 target enrollmentApril 1, 2023

ConditionsAcute Ischemic Stroke Reperfusion Injury

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Acute Ischemic Stroke
Sponsor: Capital Medical University
Enrollment: 20
Locations: 1
Primary Endpoint: Infarct volume
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Ischemic post-conditioning is a neuroprotective strategy attenuating reperfusion injury in animal stroke models. The investigators have conducted a 3 + 3 dose-escalation trial to demonstrate the safety and tolerability of ischemic post-conditioning incrementally for a longer duration of up to 5 min × 4 cycles in stroke patients undergoing mechanical thrombectomy. This study aims to assess the infarct volume after ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.

Registry

clinicaltrials.gov

Start Date

April 1, 2023

End Date

January 28, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Capital Medical University

Responsible Party

Principal Investigator

Ji Xunming,MD,PhD

Professor

Capital Medical University

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years;
•Acute ischemic stroke within 24 hours from stroke onset (or from time last known well) to groin puncture;
•Previous mRS ≤ 2;
•Baseline NIHSS ≥ 6;
•Baseline ASPECTS ≥ 6;
•With an occlusion of unilateral middle cerebral artery M1 segment/distal intracranial carotid artery;
•Successful recanalization (mTICI ≥ 2b) after thrombectomy confirmed by DSA;
•Written informed consent provided by the patients or their legal relatives.

Exclusion Criteria

•Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia;
•Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
•Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy;
•\> 2 times balloon dilations as rescue therapy due to angioplasty during thrombectomy;
•Moderate/severe residual stenosis (≥ 50%) in the offending artery after thrombectomy;
•Patients with contraindications to MRI;
•Other conditions that the investigator considered inappropriate for inclusion.

Outcomes

Primary Outcomes

Infarct volume

Time Frame: 72 hours after procedure

Infarct volume at 72 hours after procedure

Secondary Outcomes

The progression of infarct volume(Baseline and 72 hours after procedure)
The proportion of functional independence at 90 days(90 days after procedure)
The distribution of the mRS score at 90 days(90 days after procedure)
The proportion of early neurological improvement(24 hours after procedure)
Recanalization rate(24 hours after procedure)
National Institute of Health Stroke Scale (NIHSS) score(24 hours after procedure)
The proportion of favorable outcome at 90 days(90 days after procedure)
NIHSS score at 7 days after procedure/discharge(7 days after procedure/discharge)
Hemodynamic assessment(Within 24 hours after procedure)