Assessment of One-shot Cardiac-cervical-intracranial MRI in the Etiological Work up of Ischemic Stroke and Transient Ischemic Attacks (Concise)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Stroke; Transient Ischemic Attack
• Intervention / Treatment: Other: Current guidelines; Other: cc-MRI

• Study Type: Interventional
• Enrollment (Anticipated): 244
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MECHTOUFF Laura, MD; Phone Number: 04 27 85 67 47; Email: laura.mechtouff@chu-lyon.fr
• Study Contact Backup: Name: MANSUY Adeline; Phone Number: O4 72 11 51 70; Email: adeline.mansuy@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69500
    • Hospices Civils de Lyon
    • Contact: MANSUY ADELINE; Phone Number: 04 72 11 51 70; Email: adeline.mansuy@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Reference strategy; correspond to the reference techniques according to the current guidelines in the etiological work up of ischemic strokes and TIA	Other: Current guidelines; 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
Other: Evaluated strategy; correspond to perform the cci-MR: cardiac MRI with late-enhancement, angio-MRI of the cervical and intracranial arteries	Other: cc-MRI; of one-shot cardiac-cervical-intracranial MRI: cardiac MRI with late-enhancement, angio-MRI of the cervical and intracranial arteries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Study Director: MECHTOUFF Laura, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Ischemic Attack, Transient; Cerebral Infarction
• Other Study ID Numbers: 69HCL17_0394; 2020-A00071-38 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No