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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00071-38 | Other Identifier | IDRCB |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference strategy | Other | correspond to the reference techniques according to the current guidelines in the etiological work up of ischemic strokes and TIA |
|
| Evaluated strategy | Other | correspond to perform the cci-MR: cardiac MRI with late-enhancement, angio-MRI of the cervical and intracranial arteries |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Current guidelines | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 8 days after hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 8 days after hospitalization |
| To evaluate the agreement between cci-MR and the reference method for each etiological subgroup: in the context of ischemic stroke or TIA. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MECHTOUFF Laura, MD | Contact | 04 27 85 67 47 | laura.mechtouff@chu-lyon.fr | |
| MANSUY Adeline | Contact | O4 72 11 51 70 | adeline.mansuy@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| MECHTOUFF Laura, MD | Hospices Civils de Lyon | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon | Bron | 69500 | France |
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| cc-MRI | Other | of one-shot cardiac-cervical-intracranial MRI: cardiac MRI with late-enhancement, angio-MRI of the cervical and intracranial arteries |
|
Agreement for each etiological subgroup between cci-MR and the reference method. |
| Within 8 days after hospitalization |
| To assess the improvement of the detection of myocardial scar with cci-MR compared to reference strategy | Presence or absence of ischemic myocardial scar | Within 8 days after hospitalization |
| 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. | Within 8 days after hospitalization |
| 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 | Within 8 days after hospitalization |
| 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 | Within 8 days after hospitalization |
| 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 | Within 8 days after hospitalization |
| 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 | Within 8 days after hospitalization |
| 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 | Within 8 days after hospitalization |
| 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 | Within 8 days after hospitalization |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
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