Clinical trial NCT05909982: Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-1b)
Official title: Effect of Ischemic Post-conditioning on Infarct Volume in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Ischemic Stroke
Reperfusion Injury
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Infarct volume
timeFrame: 72 hours after procedure
Secondary outcomes:
measure: The progression of infarct volume
timeFrame: Baseline and 72 hours after procedure
measure: The proportion of functional independence at 90 days
timeFrame: 90 days after procedure
measure: The proportion of favorable outcome at 90 days
timeFrame: 90 days after procedure
measure: The distribution of the mRS score at 90 days
timeFrame: 90 days after procedure
measure: National Institute of Health Stroke Scale (NIHSS) score
timeFrame: 24 hours after procedure
measure: The proportion of early neurological improvement
timeFrame: 24 hours after procedure
measure: NIHSS score at 7 days after procedure/discharge
timeFrame: 7 days after procedure/discharge
measure: Recanalization rate
timeFrame: 24 hours after procedure
measure: Hemodynamic assessment
timeFrame: Within 24 hours after procedure
Other outcomes:
measure: Safety outcome (mortality at 90 days)
timeFrame: 90 days after procedure
measure: Safety outcome (the proportion of symptomatic intracranial hemorrhage within 24 hours)
timeFrame: Within 24 hours after procedure
measure: Safety outcome (the proportion of intracranial hemorrhage within 24 hours)
timeFrame: Within 24 hours after procedure
measure: Safety outcome (the proportion of malignant brain edema within 24 hours)
timeFrame: Within 24 hours after procedure
measure: Procedure-related complications
timeFrame: During the procedure
Locations:
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
Study officials:
References:
citation: Wu L, Zhang B, Zhao W, Ji X, Wei M. Ischemic post-conditioning in acute ischemic stroke thrombectomy: A phase-I duration escalation study. Front Neurosci. 2022 Dec 8;16:1054823. doi: 10.3389/fnins.2022.1054823. eCollection 2022.