Neuroprotective Effect of Remote Ischemic Conditioning in Ischemic Stroke Treated With Mechanical Thrombectomy (PROTECT-I)

Civil Hospices of Lyon

Status: Completed

Conditions: Stroke, Ischemic

Treatments: Device: Patients with a sham procedure of remote ischemic conditioning; Device: Remote ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT03915782

2019-A01052-55 (Other Identifier)

69HCL19_0129

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Non inclusion Criteria:

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 2 patient groups

Remote Ischemic Conditioning (RIC) positive

Experimental group

Description:

Patients with remote ischemic conditioning

Treatment:

Device: Remote ischemic conditioning

Control group

Sham Comparator group

Description:

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).

Treatment:

Device: Patients with a sham procedure of remote ischemic conditioning