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Stroke, IschemicPROTECT-INCT03915782

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

A study testing Remote ischemic conditioning in people with Stroke, Ischemic, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Ischemic
What is being tested?
Remote ischemic conditioning
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
132 participants
Where
1 siteFrance
Study dates
20 Mar 2020to 21 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 17Show fewer
  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Service De Neurologie Vasculaire - Hôpital Neurologique Pierre Wertheimer (GHE)

    Bron

Other trials in France

About this study

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

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.

Being tested
Remote ischemic conditioning, Patients with a sham procedure of remote ischemic conditioning
Keywords
Ischemic stroke, Mechanical Thrombectomy, Ischemia/Reperfusion, Remote Ischemic Conditioning, Magnetic Resonance Imaging
Medical subject headings
Ischemic Stroke, Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote ischemic conditioningDevice

    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).

  • Patients with a sham procedure of remote ischemic conditioningDevice

    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).

Study groups in NCT03915782
Study groupRoleWhat they receive
Remote Ischemic Conditioning (RIC) positiveExperimentalPatients with remote ischemic conditioning
Receives: Device: Remote ischemic conditioning
Control groupSham comparatorThe 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).
Receives: Device: Patients with a sham procedure of remote ischemic conditioning

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 1 after thrombectomy

Secondary outcomes (8)
  1. Change in Neurological prognosis

    Functional neurological prognosis assessed by: 1/ National Institutes of Health Stroke Scale (NIHSS) score on day 7 (NIHSS score for each ability is a number between 0 and 4 with 0 being normal functioning and 4 being completely impaired. The patient's NIHSS score is calculated by adding the number for each element of the scale; 42 is the highest score possible. The higher the score, the more impaired neurologically a stroke patient is) 2/ Modified Rankin Score (MRS) score at 90 days (score from 0 to 6 with 0 being normal functioning and 6 being death, the higher the score the more impaired neurologically a stroke patient is) and 3/ Incidence of early neurological worsening (Difference in NIHSS score between inclusion and day 1 > 4 points).

    Measured: 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.

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

    It will be expressed as a percentage of the size of the hypoperfused area measured on the admission Magnetic Resonance Imaging (MRI).

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

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

    The Thrombolysis in Cerebral Infarction (TICI) score is a tool for determining the response of thrombolytic therapy for ischemic stroke and is defined as follows: 0=no perfusion; 1= penetration, but no distal branch filling; 2a= perfusion with incomplete (<50%) distal branch filling; 2b=perfusion with incomplete (>50%) distal branch filling; and 3=full perfusion with filling of all distal branches. A score of 0 being the least favorable outcome for the patient (no perfusion) and a maximum score of 3 being the most favorable outcome for the patient (full perfusion).

    Measured: Day 1 of thrombectomy

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

    Arterial reperfusion according to the Arterial Occlusive Lesion (AOL) score. This score is related to recanalization of the primary arterial occlusive lesion on a scale of 0 to 3 : 0 is no recanalization of the primary occlusive lesion; 1 is incomplete or partial recanalization of the primary occlusive lesion with no distal flow; 2 is incomplete or partial recanalization of the primary lesion with any distal flow; and 3 is complete recanalization of the primary occlusive lesion with any distal flow. The most favorable outcome for the patient is a score of 3 while a score of 0 is the least favorable patient outcome.

    Measured: Day 1

  5. Impact on collateral circulation assessed by the Higashida score.

    Higashida score offers a non-invasive collateral vessel and tissue perfusion assessment of ischemic tissue. This grading system subdivides the collateral flow into five grades, from grade 0 (no collaterals visible on the ischemic side) to grade 5 (complete and rapid collateral blood flow to the vascular bed in the entire ischemic territory by retrograde perfusion). A grade of 3-5 is considered good collateral formation whereas a grade of 0-2 is considered poor collateral formation after a stroke and is less favorable to the patient's outcome.

    Measured: Day 1

  6. Incidence of hemorrhagic transformation at day 1 measured by routine Magnetic Resonance Imaging (MRI)

    European Cooperative Acute Stroke Study (ECASS) classification of potential haemorrhagic transformation which divides hemorrhagic transformation into four subtypes: 1) hemorrhagic infarction type 1 (HI1) such as petechial hemorrhages at the infarct margins; 2) hemorrhagic infarction type 2 (HI2) such as petechial hemorrhages throughout the infarct and no mass-effect attributable to the hemorrhages; 3) parenchymal hematoma type 1 (PH1) such as less than or equal to 30% of the infarcted area minor mass effect attributable to the hematoma and 4) parenchymal hematoma type 2 (PH2) such as greater than 30% of infarct zone substantial mass effect attributable to the hematoma. The most favorable patient outcome being the first classification hemorrhagic infarction type 1 (HI1) and the least favorable patient outcome being the fourth classification parenchymal hematoma type 2 (PH2).

    Measured: Day 1

  7. Complications related to the endovascular procedure

    Complications such as: embolism in an another initially not involved vascular territory, dissection, severe vasospasm that needs an intra-arterial treatment, vascular perforation

    Measured: Day 1

  8. Responder analysis to thrombectomy relating Modified Rankin score (mRS) 90 days after stroke to baseline National Institutes of Health Stroke Scale (NIHSS) score.

    NIHSS score for each ability is a number between 0 and 4 with 0 being normal functioning and 4 being completely impaired. The patient's NIHSS score is calculated by adding the number for each element of the scale; 42 is the highest score possible. The higher the score, the more impaired a stroke patient is. MRS score from 0 to 6 with 0 being normal functioning and 6 being death, the higher the score the more impaired a stroke patient is. For this study a positive response is defined by : a NIHSS <7 at admission and a MRS = 0 at Day 90 ; a NIHSS between 8 and 14 at admission and a MRS = 0 or 1 at Day 90 ; a NIHSS >14 at admission and a MRS = 0 to 2 at Day 90.

    Measured: Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2019
  2. Study start20 Mar 2020
  3. Primary completion11 Jul 2024
  4. Study completion21 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03915782
Sponsor's protocol ID
69HCL19_0129
Other IDs
2019-A01052-55
Acronym
PROTECT-I
Status last verified
Dec 2024
First submitted
11 Apr 2019
Last updated
12 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Remote ischemic conditioning in people with Stroke, Ischemic, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Final volume of cerebral infarction measured by Magnetic Resonance Imaging (MRI) at Day 1 after thrombectomy (time frame: Day 1 after thrombectomy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.

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