Clinical trial NCT03915782: Neuroprotective Effect of Remote Ischemic Conditioning in Ischemic Stroke Treated With Mechanical Thrombectomy
Official title: NeuroPRotective Effect of remOte Ischemic condiTioning in Ischemic strokE Treated With meChanical Thrombectomy (PROTECT-I Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Keywords: Ischemic stroke
Mechanical Thrombectomy
Ischemia/Reperfusion
Remote Ischemic Conditioning
Magnetic Resonance Imaging
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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),
* 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

Primary outcomes:
measure: Final volume of cerebral infarction measured by Magnetic Resonance Imaging (MRI) at Day 1 after thrombectomy
timeFrame: Day 1 after thrombectomy
Secondary outcomes:
measure: Change in Neurological prognosis
timeFrame: 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.
measure: Change in growth of the supposed irreversible lesion measured by Magnetic Resonance Imaging (MRI) from admission to day 1.
timeFrame: Magnetic Resonance Imaging (MRI) will be performed at inclusion (Day 0) and on day 1.
measure: Arterial reperfusion measured by the Thrombolysis in Cerebral Infarction (TICI) score at the end of the thrombectomy procedure.
timeFrame: Day 1 of thrombectomy
measure: Arterial reperfusion measured at Day 1 by Magnetic Resonance Imaging (MRI).
timeFrame: Day 1
measure: Impact on collateral circulation assessed by the Higashida score.
timeFrame: Day 1
measure: Incidence of hemorrhagic transformation at day 1 measured by routine Magnetic Resonance Imaging (MRI)
timeFrame: Day 1
measure: Complications related to the endovascular procedure
timeFrame: Day 1
measure: Responder analysis to thrombectomy relating Modified Rankin score (mRS) 90 days after stroke to baseline National Institutes of Health Stroke Scale (NIHSS) score.
timeFrame: Day 90
Other outcomes:
Locations:
city: Bron
country: France
facility: Service De Neurologie Vasculaire - Hôpital Neurologique Pierre Wertheimer (GHE)
Study officials:
affiliation: Hospices Civils de Lyon, Hopital Pierre Wertheimer
name: Laura MECHTOUFF, MD
role: PRINCIPAL_INVESTIGATOR
References: