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.
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.
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- 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
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.
- Conditions
- Stroke, Ischemic
- 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 group | Role | What they receive |
|---|---|---|
| Remote Ischemic Conditioning (RIC) positive | Experimental | Patients with remote ischemic conditioning Receives: 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). 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.
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)
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.
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.
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
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
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
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
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
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.
- First posted16 Apr 2019
- Study start20 Mar 2020
- Primary completion11 Jul 2024
- Study completion21 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura MECHTOUFF, MD, Principal investigator, Hospices Civils de Lyon, Hopital Pierre Wertheimer
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeuroPRotective Effect of remOte Ischemic condiTioning in Ischemic strokE Treated With meChanical Thrombectomy (PROTECT-I Study)
- ClinicalTrials.gov ID
- NCT03915782
- Acronym / sponsor ID
- PROTECT-I / 69HCL19_0129
- Conditions
- Stroke, Ischemic
- Keywords
- Ischemic stroke, Mechanical Thrombectomy, Ischemia/Reperfusion, Remote Ischemic Conditioning, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 11 Jul 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic Conditioning (RIC) positive | Experimental | Device: Remote ischemic conditioningPatients with remote ischemic conditioning |
| Control group | Sham comparator | Device: Patients with a sham procedure of remote ischemic conditioningThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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,
Key exclusion criteria (1 listed)
- Recanalization of M1 or proximal M2 segment at the time of thrombectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic conditioningRemote 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). | Device | Remote Ischemic Conditioning (RIC) positive |
| Patients with a sham procedure of remote ischemic conditioningSham 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). | Device | Control group |
Primary outcome
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.
8 secondary outcomes
Change in Neurological prognosis
Time frame: 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.
Time frame: 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.
Time frame: Day 1 of thrombectomy
Arterial reperfusion measured at Day 1 by Magnetic Resonance Imaging (MRI).
Time frame: Day 1
Impact on collateral circulation assessed by the Higashida score.
Time frame: Day 1
Incidence of hemorrhagic transformation at day 1 measured by routine Magnetic Resonance Imaging (MRI)
Time frame: Day 1
Complications related to the endovascular procedure
Time frame: 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.
Time frame: Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura MECHTOUFF, MD principal investigator
Hospices Civils de Lyon, Hopital Pierre Wertheimer
1 site in 1 country: see every site and its status.
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.