Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-1b)

Acute Ischemic Stroke Clinical Trial

— PROTECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05909982
• Other study ID #: PROTECT-1b
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 1, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: June 2023
• Source: Capital Medical University
• Contact: Xunming Ji, MD
• Phone: +86-10-83198952
• Email: jixm[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Reperfusion Injury
• Stroke

Intervention

Procedure:
• Mechanical thrombectomy combined with ischemic post-conditioning
Ischemic post-conditioning will be applied after successful recanalization of the culprit artery by thrombectomy. Ischemic post-conditioning consists of briefly repeated four cycles × 2 minutes of occlusion and reperfusion (equal duration) of the initially occluded artery using a balloon.

Locations

Country	Name	City	State
China	Tianjin Huanhu Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety outcome (mortality at 90 days)	90-day mortality	90 days after procedure
Other	Safety outcome (the proportion of symptomatic intracranial hemorrhage within 24 hours)	The proportion of symptomatic intracranial hemorrhage within 24 hours after procedure	Within 24 hours after procedure
Other	Safety outcome (the proportion of intracranial hemorrhage within 24 hours)	The proportion of intracranial hemorrhage within 24 hours after procedure	Within 24 hours after procedure
Other	Safety outcome (the proportion of malignant brain edema within 24 hours)	The proportion of malignant brain edema within 24 hours after procedure	Within 24 hours after procedure
Other	Procedure-related complications	Vascular perforation/rupture, vessel dissection, severe vasospasm, rupture of the balloon used for post-conditioning	During the procedure
Primary	Infarct volume	Infarct volume at 72 hours after procedure	72 hours after procedure
Secondary	The progression of infarct volume	Difference of infarct volume between baseline and 72 hours after procedure	Baseline and 72 hours after procedure
Secondary	The proportion of functional independence at 90 days	The modified Rankin Scale (mRS) score of 0-2 at 90 days after procedure; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)	90 days after procedure
Secondary	The proportion of favorable outcome at 90 days	The mRS score of 0-3 at 90 days after procedure; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)	90 days after procedure
Secondary	The distribution of the mRS score at 90 days	The distribution of the mRS score at 90 days after procedure; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)	90 days after procedure
Secondary	National Institute of Health Stroke Scale (NIHSS) score	NIHSS score at 24 hours after procedure; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits	24 hours after procedure
Secondary	The proportion of early neurological improvement	NIHSS 0-2 or =8 lower than baseline NIHSS score at 24 hours after procedure; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits	24 hours after procedure
Secondary	NIHSS score at 7 days after procedure/discharge	NIHSS score at 7 days after procedure/discharge; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits	7 days after procedure/discharge
Secondary	Recanalization rate	Recanalization rate at 24 hours after procedure (mTICI =2b)	24 hours after procedure
Secondary	Hemodynamic assessment	Hemodynamic assessment within 24 hours after procedure	Within 24 hours after procedure