NeuroPRotective Effect of remOte Ischemic condiTioning in Ischemic strokE Treated With meChanical Thrombectomy (PROTECT-I Study)

Hospices Civils de Lyon1 site in 1 country132 target enrollmentMarch 20, 2020

ConditionsStroke, Ischemic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke, Ischemic
Sponsor: Hospices Civils de Lyon
Enrollment: 132
Locations: 1
Primary Endpoint: Final volume of cerebral infarction measured by Magnetic Resonance Imaging (MRI) at Day 1 after thrombectomy
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 20, 2020

End Date

October 21, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospices Civils de Lyon

Responsible Party

Sponsor

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.
•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),

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

Complications related to the endovascular procedure(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)
Impact on collateral circulation assessed by the Higashida score.(Day 1)
Incidence of hemorrhagic transformation at day 1 measured by routine Magnetic Resonance Imaging (MRI)(Day 1)
Responder analysis to thrombectomy relating Modified Rankin score (mRS) 90 days after stroke to baseline National Institutes of Health Stroke Scale (NIHSS) score.(Day 90)
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.)
Arterial reperfusion measured at Day 1 by Magnetic Resonance Imaging (MRI).(Day 1)