Ischemic Stroke, AcuteMR-ReperfusionNCT04952077
MRI Biomarkers of Effective Tissue Reperfusion After Thrombectomy of an Acute Proximal Occlusion of the Anterior Circulation
A study testing MRI in people with Ischemic Stroke, Acute, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Cerebral infarction by proximal occlusion of the anterior circulation is common with major personal and societal consequences. MRI is the gold standard for exploring stroke, especially ischemic, and a number of biomarkers on initial MRI (before reperfusion) are predictive of neurological prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Acute
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2023to 31 Dec 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
- To be over 18 year-old
- Perfusion MRI assessment on admission;
- Admission for an acute infarction of the anterior circulation with proximal occlusion (tandem, distal internal carotid, or M1 segment of the middle cerebral artery);
- Initial mTICI = 0-1 on the initial angiography before treatment;
- Patient in complete autonomy (mRS ≤ 2) before the onset of symptoms;
- Mechanical thrombectomy (in combination or not with intravenous thrombolysis), within the first 6 hours of the onset of symptoms, or within 24 hours in case of clinical-radiological or radiological mismatch;
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- Success of reperfusion estimated by an mTICI = 3 at the end of the procedure;
- Availability of MRI within 3 hours of angiographic reperfusion;
- To be able to understand the instructions given;
- Written consent given by the patient or a trusted person;
- To be enrolled in a social security plan;
Who cannot join
- Posterieur circulation obstruction;
- 3 months follow-up impossible with the completion of the MRI;
- Subject under a measure of legal protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU Nancy
Nancy
Liang LIAO, MD, l.liao@chru-nancy.fr
About this study
Official title: MRI Biomarkers of Effective Tissue Reperfusion After Thrombectomy of an Acute Proximal Occlusion of the Anterior Circulation: MR-Reperfusion Longitudinal Study
Cerebral infarction by proximal occlusion of the anterior circulation is common with major personal and societal consequences.
MRI is the gold standard for exploring stroke, especially ischemic, and a number of biomarkers on initial MRI (before reperfusion) are predictive of neurological prognosis. However, their spatiotemporal evolution in the suites of reperfusion is unclear.
Read more
Close monitoring by MRI would make it possible to precisely know the tissue, vascular and microvascular evolution of the infarct area and the penumbra after reperfusion, and thus to characterize MRI biomarkers associated with efficient tissue reperfusion.
The aim of the MR-Reperfusion study is to characterize new MRI biomarkers of efficient tissue reperfusion.
- Conditions
- Ischemic Stroke, Acute
- Being tested
- MRI
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Magnetic Resonance Imaging (MRI)
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of MRI biomarkers (volume, location of the infarction and penumbra; collateral circulation; location, length of the thrombus; trans-cerebral, cortical venous changes) in patients with ischemic stroke successfully treated by thrombectomy
Measured: Admission to hospital, 3 hours, 24 hours, 7 days and 3 months after thrombectomy
Secondary outcomes (4)
Kinetic evolution of MRI biomarkers (volume, location of the infarction and penumbra; collateral circulation; location, length of the thrombus; trans-cerebral, cortical venous changes) and its correlation with the functional prognosis (mRS score)
Measured: Admission to hospital, 3 hours, 24 hours, 7 days and 3 months after thrombectomy
Kinetic evolution of the NIHSS score and its correlation with the functional prognosis at 3 months evaluated by the mRS score.
Measured: Admission to hospital, 3 hours, 24 hours, 7 days and 3 months after thrombectomy
Description of MRI biomarkers (volume, location of the infarction and penumbra; collateral circulation; location, length of the thrombus; trans-cerebral, cortical venous changes) and its correlation with the hemorrhagic transformation (SWAN sequence)
Measured: 24 hours after thrombectomy
Radioclinical concordance evaluated by measuring MRI biomarkers (volume, location of the infarction and penumbra; collateral circulation; location, length of the thrombus; trans-cerebral, cortical venous changes), the mRS score and the NIHSS score
Measured: 3 months after thrombectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start15 Apr 2023 (estimated)
- Primary completion15 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang LIAO, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952077
- Sponsor's protocol ID
- 2021-A00716-35
- Acronym
- MR-Reperfusion
- Status last verified
- Apr 2023
- First submitted
- 17 Jun 2021
- Last updated
- 13 Apr 2023
- 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 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Biomarkers of Effective Tissue Reperfusion After Thrombectomy of an Acute Proximal Occlusion of the Anterior Circulation: MR-Reperfusion Longitudinal Study
- ClinicalTrials.gov ID
- NCT04952077
- Acronym / sponsor ID
- MR-Reperfusion / 2021-A00716-35
- Conditions
- Ischemic Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Apr 2023 (estimated)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Jul 2021 (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.
Cerebral infarction by proximal occlusion of the anterior circulation is common with major personal and societal consequences.
MRI is the gold standard for exploring stroke, especially ischemic, and a number of biomarkers on initial MRI (before reperfusion) are predictive of neurological prognosis. However, their spatiotemporal evolution in the suites of reperfusion is unclear.
Close monitoring by MRI would make it possible to precisely know the tissue, vascular and microvascular evolution of the infarct area and the penumbra after reperfusion, and thus to characterize MRI biomarkers associated with efficient tissue reperfusion.
The aim of the MR-Reperfusion study is to characterize new MRI biomarkers of efficient tissue reperfusion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- To be over 18 year-old
- Perfusion MRI assessment on admission;
- Admission for an acute infarction of the anterior circulation with proximal occlusion (tandem, distal internal carotid, or M1 segment of the middle cerebral artery);
- Initial mTICI = 0-1 on the initial angiography before treatment;
- Patient in complete autonomy (mRS ≤ 2) before the onset of symptoms;
Key exclusion criteria (3 listed)
- Posterieur circulation obstruction;
- 3 months follow-up impossible with the completion of the MRI;
- Subject under a measure of legal protection
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 |
|---|---|---|
| MRIMagnetic Resonance Imaging (MRI) | Device | Experimental |
Primary outcome
Description of MRI biomarkers (volume, location of the infarction and penumbra; collateral circulation; location, length of the thrombus; trans-cerebral, cortical venous changes) in patients with ischemic stroke successfully treated by thrombectomy
Time frame: Admission to hospital, 3 hours, 24 hours, 7 days and 3 months after thrombectomy
4 secondary outcomes
Kinetic evolution of MRI biomarkers (volume, location of the infarction and penumbra; collateral circulation; location, length of the thrombus; trans-cerebral, cortical venous changes) and its correlation with the functional prognosis (mRS score)
Time frame: Admission to hospital, 3 hours, 24 hours, 7 days and 3 months after thrombectomy
Kinetic evolution of the NIHSS score and its correlation with the functional prognosis at 3 months evaluated by the mRS score.
Time frame: Admission to hospital, 3 hours, 24 hours, 7 days and 3 months after thrombectomy
Description of MRI biomarkers (volume, location of the infarction and penumbra; collateral circulation; location, length of the thrombus; trans-cerebral, cortical venous changes) and its correlation with the hemorrhagic transformation (SWAN sequence)
Time frame: 24 hours after thrombectomy
Radioclinical concordance evaluated by measuring MRI biomarkers (volume, location of the infarction and penumbra; collateral circulation; location, length of the thrombus; trans-cerebral, cortical venous changes), the mRS score and the NIHSS score
Time frame: 3 months after thrombectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Ischemic Stroke, Acute, run by Central Hospital, Nancy, France 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 11 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Apr 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liang LIAO, MD (+33383851618, l.liao@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of MRI biomarkers (volume, location of the infarction and penumbra; collateral circulation; location, length of the thrombus; trans-cerebral, cortical venous changes) in patients with ischemic stroke successfully treated by thrombectomy (time frame: Admission to hospital, 3 hours, 24 hours, 7 days and 3 months 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 13 Apr 2023.