Neuroprotective Effect of Remote Ischemic Conditioning in Ischemic Stroke Treated With Mechanical Thrombectomy

NCT ID: NCT03915782

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-20
• Study Completion Date: 2024-10-21

Brief Summary

The benefit of mechanical thrombectomy in the treatment of ischemic stroke has been demonstrated in several multicenter randomized trials. However, it leads to a sudden reperfusion of the brain parenchyma associated to an extension of the infarct volume. Evidence has indicated that remote ischemic conditioning (RIC) reduces final infarct size in animal stroke models. The main objective of the present study is to determine whether remote ischemic conditioning can limit the final infarct volume after recanalization of the occluded cerebral artery.

Conditions

Stroke, Ischemic

Keywords

Ischemic stroke; Mechanical Thrombectomy; Ischemia/Reperfusion; Remote Ischemic Conditioning; Magnetic Resonance Imaging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Remote Ischemic Conditioning (RIC) positive

Patients with remote ischemic conditioning

Group Type: EXPERIMENTAL

Remote ischemic conditioning

Intervention Type: DEVICE

Remote ischemic conditioning (RIC): Four cycles of \[5 minutes of brachial cuff inflation at 200 millimeters (mm) of mercury (Hg) followed by 5 minutes of cuff deflation\] started as soon as possible after Magnetic Resonance Imaging (MRI).

Control group

The control group will receive a sham procedure (same procedure than Remote Ischemic Conditioning (RIC) with brachial cuff inflation to 30 millimeters (mm) of mercury (Hg) during 40 minutes).

Group Type: SHAM_COMPARATOR

Patients with a sham procedure of remote ischemic conditioning

Intervention Type: DEVICE

Sham procedure: Four cycles of \[5 minutes of brachial cuff inflation at 30 millimeters (mm) of mercury (Hg) followed by 5 minutes of cuff deflation\] started as soon as possible after Magnetic Resonance Imaging (MRI).

Interventions

Remote ischemic conditioning

Remote ischemic conditioning (RIC): Four cycles of \[5 minutes of brachial cuff inflation at 200 millimeters (mm) of mercury (Hg) followed by 5 minutes of cuff deflation\] started as soon as possible after Magnetic Resonance Imaging (MRI).

Intervention Type: DEVICE

Patients with a sham procedure of remote ischemic conditioning

Sham procedure: Four cycles of \[5 minutes of brachial cuff inflation at 30 millimeters (mm) of mercury (Hg) followed by 5 minutes of cuff deflation\] started as soon as possible after Magnetic Resonance Imaging (MRI).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age at least 18 years old,
• Carotid ischemic stroke related to a full occlusion of the middle cerebral artery (occlusion of middle 1 (M1) and/or proximal middle 2 (M2) identified as candidate for endovascular intervention according to local criteria,
• Brain Magnetic Resonance Imaging (MRI) performed within 6 hours from symptoms onset,
• Acute stroke MRI including at least diffusion weighted imaging (DWI), fluid attenuated inversion recovery (FLAIR), intracranial vessel imaging with Magnetic Resonance Angiography (MRA) and perfusion weighted imaging (PWI),
• Modified Rankin Score (mRS) score less than or equal to 1 before ischemic stroke,
• Obtaining a written informed consent of the patient or a next of kin, or emergency inclusion process.

• Previous ischemic stroke or transient ischemic attack (TIA) in the previous 3 months,
• Contraindications to iodinated contrast agents,
• Sickle cell disease known (risk of vaso-occlusive crisis),
• Life expectancy less than 90 days,
• Pregnant or women of childbearing age who were not using contraception (oral diagnosis),
• Patient without health coverage,
• Patient under legal protection.
• Any contraindication to Magnetic Resonance Imaging (MRI) (example cardiac pacemaker),
• Intracranial bleeding,
• Intracranial expansive process.

Exclusion Criteria

• Recanalization of M1 or proximal M2 segment at the time of thrombectomy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura MECHTOUFF, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon, Hopital Pierre Wertheimer

Locations

Service De Neurologie Vasculaire - Hôpital Neurologique Pierre Wertheimer (GHE)

Bron, , France

Countries

France

Other Identifiers

2019-A01052-55

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL19_0129

Identifier Type: -

Identifier Source: org_study_id