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NCT03915782Completed

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

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

Source: ClinicalTrials.gov · Last updated 12 Dec 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
132 (actual)
First submitted
11 Apr 2019
Start date
20 Mar 2020
Primary completion date
11 Jul 2024
Lead sponsor
Hospices Civils de Lyon
Diseases
Stroke
NCT number
NCT03915782

What you commit to

  • Study type: Interventional
  • Participants enrolled: 132
  • From 20 Mar 2020 to the primary completion date, 11 Jul 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Service De Neurologie Vasculaire - Hôpital Neurologique Pierre Wertheimer (GHE)
Coordinator of this site? Confirm its status		BronFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.