Back to resultsAssessment of One-shot Cardiac-cervical-intracranial MRI in the Etiological Work up of Ischemic Stroke and Transient Ischemic Attacks (Concise)
Primary Purpose
Ischemic Stroke, Transient Ischemic Attack
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Current guidelines
cc-MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Ischemic Stroke
Eligibility Criteria
Inclusion Criteria:
- • Man or woman aged from 18 to 85 years old,
- Patients victims of an ischemic stroke or a TIA in the 2 days before inclusion, Symptoms thought to be consistent with TIA were those defined by the ad hoc Committee established by the Advisory Council for the National Institute of Neurological and Communicative Disorders and Stroke65
- Rankin score: mRS ≤3
- Patient having given their free written and informed consent, or preliminary oral informed consent attested by a third party followed by signed informed consent as soon as possible,
- Affiliated to a social security scheme or equivalent,
- That are not the subject of any legal protection measures
Exclusion Criteria:
- •TIA symptoms limited to isolated numbness,
- changes, or isolated dizziness/vertigo
- Agitation, severe swallowing
- Contraindication to an MRI and the injection of gadolinium,
- Known history of hypersensitivity to the MRI contrast product,
- Risk of pregnancy or known pregnancy revealed when questioned, Breastfeeding,
- Patient unable to understand or poorly understanding French.
Sites / Locations
- Hospices Civils de Lyon
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Reference strategy
Evaluated strategy
Arm Description
correspond to the reference techniques according to the current guidelines in the etiological work up of ischemic strokes and TIA
correspond to perform the cci-MR: cardiac MRI with late-enhancement, angio-MRI of the cervical and intracranial arteries
Outcomes
Primary Outcome Measures
To evaluate the consistency between the reference strategy and the cci-MR strategy for etiological work up according to the ASCOD classification, in ischemic stroke and TIA patients
The primary endpoint will be based on the consistency for each patient of the etiological work up according to the ASCOD classification evaluated with cci-MR in comparison of the reference strategy
Secondary Outcome Measures
To assess the reproducibility of the assessment of the cci-MR results
The reproducibility of the assessment of the cci-MR results will be based on the following endpoints:
- Double reading; Concordance intra and inter reviewer
To evaluate the agreement between cci-MR and the reference method for each etiological subgroup: in the context of ischemic stroke or TIA.
Agreement for each etiological subgroup between cci-MR and the reference method.
To assess the improvement of the detection of myocardial scar with cci-MR compared to reference strategy
Presence or absence of ischemic myocardial scar
To assess the atherosclerotic burden (coronary, intracranial, cervical, aortic) assessed with cci-MR compared to the reference strategy,
Presence or absence of coronary, intracranial, cervical, aortic atheroma. The diagnostic work up will focus on cervical artery stenosis ≥ 50%; aortic arch atheroma ≥ 4 mm; intracranial artery stenosis ≥ 50% and presence of ischemic myocardial scar. The scar pattern was classified as ischemic if its distribution was sub-endocardial to transmural within a coronary vascular territory and if scar was associated with segmental systolic dysfunction on corresponding cine images. Atherosclerotic burden will be classified in 0, 1, 2, 3 and 4 atherosclerotic levels according to the number of arterial territories affected by at least one significant abnormality.
To assess the additional yield of cci-MR in cryptogenic patients and in those with embolic stroke of undetermined source (ESUS) with the reference strategy (ref Hart et al., Lancet Neurol. 2014:13:429-438.)
Etiology subtype according to ASCOD classification with the reference strategy + cci-MR in cryptogenic patients and in the subgroup of patients with ESUS with the reference strategy
To assess the rate of TEE recommended according to the opinion of the expert committee from data obtained with cci-MR and the reference strategy
Presence or absence of recommendation to realize a TEE according to the opinion of the expert committee from data obtained with cci-MR and with the reference strategy
To assess the rate of additional cardiologic advice recommended according to the opinion of the expert committee from data obtained with cci-MR and with the reference strategy
Presence or absence of recommendation to have a cardiologic advice according to the opinion of the expert committee from data obtained cci-MR and with the reference strategy
To assess the preventive treatment recommended (antithrombotic drugs and specific treatments) according to the opinion of the expert committee from data obtained with cci-MR and with the reference strategy
Presence or absence of recommendation of having antiplatelet, anticoagulant, and of having a specific care (carotid surgery, PFO closure…) according to the opinion of the expert committee from data obtained with cci-MR and with the reference strategy
To assess the feasibility of the examinations (rate of completed examinations, deadline to obtain each examination, deadline to obtain all examinations including in each strategy)
Presence or absence of full completed examinations, deadline between the date of ischemic stroke or TIA and each examination, deadline between the date of ischemic stroke or TIA and the end of all examinations including in each strategy
To assess the feeling of the patient about cci-MR and the reference strategy
Level of satisfaction of the patient about cci-MR and the reference strategy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04790357
Brief Title
Assessment of One-shot Cardiac-cervical-intracranial MRI in the Etiological Work up of Ischemic Stroke and Transient Ischemic Attacks
Acronym
Concise
Official Title
Assessment of One-shot Cardiac-cervical-intracranial MRI in the Etiological Work up of Ischemic Stroke and Transient Ischemic Attacks
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Stroke is a major public health issue in developed countries. A full etiological work up within a short time is critical to implement the appropriate preventive treatment. The etiological work up is actually based on a clinical examination and on a group of paraclinical examinations. The realization of the standard strategy is time consuming, and increase the cost of the medical care. A non-invasive one-shot examination of the heart, the aorta and the cervical and intracranial arteries (cci-MRI) could overcome these disadvantages.The investigator therefore propose to carry out an overall assessment of the performance of the cci-MR in the etiological work up of ischemic strokes and TIAs compared to the reference strategy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Transient Ischemic Attack
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
244 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Reference strategy
Arm Type
Other
Arm Description
correspond to the reference techniques according to the current guidelines in the etiological work up of ischemic strokes and TIA
Arm Title
Evaluated strategy
Arm Type
Other
Arm Description
correspond to perform the cci-MR: cardiac MRI with late-enhancement, angio-MRI of the cervical and intracranial arteries
Intervention Type
Other
Intervention Name(s)
Current guidelines
Intervention Description
doppler ultrasound and/or angio CT-scan of the cervical arteries, angio CT-scan of the intracranial arteries, TTE wich can be supplemented by a TEE at the discretion of the investigator. The TEE is not mandatory
Intervention Type
Other
Intervention Name(s)
cc-MRI
Intervention Description
of one-shot cardiac-cervical-intracranial MRI: cardiac MRI with late-enhancement, angio-MRI of the cervical and intracranial arteries
Primary Outcome Measure Information:
Title
To evaluate the consistency between the reference strategy and the cci-MR strategy for etiological work up according to the ASCOD classification, in ischemic stroke and TIA patients
Description
The primary endpoint will be based on the consistency for each patient of the etiological work up according to the ASCOD classification evaluated with cci-MR in comparison of the reference strategy
Time Frame
Within 8 days after hospitalization
Secondary Outcome Measure Information:
Title
To assess the reproducibility of the assessment of the cci-MR results
Description
The reproducibility of the assessment of the cci-MR results will be based on the following endpoints:
- Double reading; Concordance intra and inter reviewer
Time Frame
Within 8 days after hospitalization
Title
To evaluate the agreement between cci-MR and the reference method for each etiological subgroup: in the context of ischemic stroke or TIA.
Description
Agreement for each etiological subgroup between cci-MR and the reference method.
Time Frame
Within 8 days after hospitalization
Title
To assess the improvement of the detection of myocardial scar with cci-MR compared to reference strategy
Description
Presence or absence of ischemic myocardial scar
Time Frame
Within 8 days after hospitalization
Title
To assess the atherosclerotic burden (coronary, intracranial, cervical, aortic) assessed with cci-MR compared to the reference strategy,
Description
Presence or absence of coronary, intracranial, cervical, aortic atheroma. The diagnostic work up will focus on cervical artery stenosis ≥ 50%; aortic arch atheroma ≥ 4 mm; intracranial artery stenosis ≥ 50% and presence of ischemic myocardial scar. The scar pattern was classified as ischemic if its distribution was sub-endocardial to transmural within a coronary vascular territory and if scar was associated with segmental systolic dysfunction on corresponding cine images. Atherosclerotic burden will be classified in 0, 1, 2, 3 and 4 atherosclerotic levels according to the number of arterial territories affected by at least one significant abnormality.
Time Frame
Within 8 days after hospitalization
Title
To assess the additional yield of cci-MR in cryptogenic patients and in those with embolic stroke of undetermined source (ESUS) with the reference strategy (ref Hart et al., Lancet Neurol. 2014:13:429-438.)
Description
Etiology subtype according to ASCOD classification with the reference strategy + cci-MR in cryptogenic patients and in the subgroup of patients with ESUS with the reference strategy
Time Frame
Within 8 days after hospitalization
Title
To assess the rate of TEE recommended according to the opinion of the expert committee from data obtained with cci-MR and the reference strategy
Description
Presence or absence of recommendation to realize a TEE according to the opinion of the expert committee from data obtained with cci-MR and with the reference strategy
Time Frame
Within 8 days after hospitalization
Title
To assess the rate of additional cardiologic advice recommended according to the opinion of the expert committee from data obtained with cci-MR and with the reference strategy
Description
Presence or absence of recommendation to have a cardiologic advice according to the opinion of the expert committee from data obtained cci-MR and with the reference strategy
Time Frame
Within 8 days after hospitalization
Title
To assess the preventive treatment recommended (antithrombotic drugs and specific treatments) according to the opinion of the expert committee from data obtained with cci-MR and with the reference strategy
Description
Presence or absence of recommendation of having antiplatelet, anticoagulant, and of having a specific care (carotid surgery, PFO closure…) according to the opinion of the expert committee from data obtained with cci-MR and with the reference strategy
Time Frame
Within 8 days after hospitalization
Title
To assess the feasibility of the examinations (rate of completed examinations, deadline to obtain each examination, deadline to obtain all examinations including in each strategy)
Description
Presence or absence of full completed examinations, deadline between the date of ischemic stroke or TIA and each examination, deadline between the date of ischemic stroke or TIA and the end of all examinations including in each strategy
Time Frame
Within 8 days after hospitalization
Title
To assess the feeling of the patient about cci-MR and the reference strategy
Description
Level of satisfaction of the patient about cci-MR and the reference strategy
Time Frame
Within 8 days after hospitalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Man or woman aged from 18 to 85 years old,
Patients victims of an ischemic stroke or a TIA in the 2 days before inclusion, Symptoms thought to be consistent with TIA were those defined by the ad hoc Committee established by the Advisory Council for the National Institute of Neurological and Communicative Disorders and Stroke65
Rankin score: mRS ≤3
Patient having given their free written and informed consent, or preliminary oral informed consent attested by a third party followed by signed informed consent as soon as possible,
Affiliated to a social security scheme or equivalent,
That are not the subject of any legal protection measures
Exclusion Criteria:
•TIA symptoms limited to isolated numbness,
changes, or isolated dizziness/vertigo
Agitation, severe swallowing
Contraindication to an MRI and the injection of gadolinium,
Known history of hypersensitivity to the MRI contrast product,
Risk of pregnancy or known pregnancy revealed when questioned, Breastfeeding,
Patient unable to understand or poorly understanding French.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MECHTOUFF Laura, MD
Phone
04 27 85 67 47
Email
laura.mechtouff@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
MANSUY Adeline
Phone
O4 72 11 51 70
Email
adeline.mansuy@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MECHTOUFF Laura, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Study Director
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MANSUY ADELINE
Phone
04 72 11 51 70
Email
adeline.mansuy@chu-lyon.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of One-shot Cardiac-cervical-intracranial MRI in the Etiological Work up of Ischemic Stroke and Transient Ischemic Attacks
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