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

NCT03915782 | Completed

• 2 other identifiers: 69HCL19_01292019-A01052-55
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Final volume of cerebral infarction measured by Magnetic Resonance Imaging (MRI) at Day 1 after thrombectomy

  Measurement of the final volume of cerebral infarction on Fluid Attenuated Inversion Recovery (FLAIR) sequence by a blinding imaging reading committee.

  Day 1 after thrombectomy

Secondary Outcomes (8)

• Change in Neurological prognosis

  1/ National Institutes of Health Stroke Scale (NIHSS) score will be evaluated at day 7; 2/ Modified Rankin Score (mRS) will be evaluated at day 90 and 3/ Incidence of early neurological worsening will be evaluated at inclusion and up to day 1.

• Change in growth of the supposed irreversible lesion measured by Magnetic Resonance Imaging (MRI) from admission to day 1.

  Magnetic Resonance Imaging (MRI) will be performed at inclusion (Day 0) and on day 1.

• Arterial reperfusion measured by the Thrombolysis in Cerebral Infarction (TICI) score at the end of the thrombectomy procedure.

  Day 1 of thrombectomy

• Arterial reperfusion measured at Day 1 by Magnetic Resonance Imaging (MRI).

  Day 1

• Impact on collateral circulation assessed by the Higashida score.

  Day 1

Study Arms (2)

Remote Ischemic Conditioning (RIC) positive

EXPERIMENTAL

Patients with remote ischemic conditioning

Device: Remote ischemic conditioning

Control group

SHAM COMPARATOR

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).

Device: Patients with a sham procedure of remote ischemic conditioning

Interventions

Remote ischemic conditioning 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).

Remote Ischemic Conditioning (RIC) positive

Patients with a sham procedure of remote ischemic conditioning 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).

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Bron, France

Location

MeSH Terms

Conditions

Ischemic Stroke; Ischemia

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura MECHTOUFF, MD

  Hospices Civils de Lyon, Hopital Pierre Wertheimer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 16, 2019
• Study Start: March 20, 2020
• Primary Completion: July 11, 2024
• Study Completion: October 21, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

FR (1)