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

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ClinicalTrials.gov Identifier: NCT04790357
Recruitment Status : Not yet recruiting
First Posted : March 10, 2021
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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

Condition or disease Intervention/treatment Phase
Ischemic Stroke Transient Ischemic Attack Other: Current guidelines Other: cc-MRI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of One-shot Cardiac-cervical-intracranial MRI in the Etiological Work up of Ischemic Stroke and Transient Ischemic Attacks
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: Within 8 days after hospitalization ]
    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 :
  1. To assess the reproducibility of the assessment of the cci-MR results [ Time Frame: Within 8 days after hospitalization ]

    The reproducibility of the assessment of the cci-MR results will be based on the following endpoints:

    - Double reading; Concordance intra and inter reviewer


  2. To evaluate the agreement between cci-MR and the reference method for each etiological subgroup: in the context of ischemic stroke or TIA. [ Time Frame: Within 8 days after hospitalization ]
    Agreement for each etiological subgroup between cci-MR and the reference method.

  3. To assess the improvement of the detection of myocardial scar with cci-MR compared to reference strategy [ Time Frame: Within 8 days after hospitalization ]
    Presence or absence of ischemic myocardial scar

  4. To assess the atherosclerotic burden (coronary, intracranial, cervical, aortic) assessed with cci-MR compared to the reference strategy, [ Time Frame: Within 8 days after hospitalization ]
    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.

  5. 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.) [ Time Frame: Within 8 days after hospitalization ]
    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

  6. 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 [ Time Frame: Within 8 days after hospitalization ]
    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

  7. 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 [ Time Frame: Within 8 days after hospitalization ]
    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

  8. 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 [ Time Frame: Within 8 days after hospitalization ]
    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

  9. 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) [ Time Frame: Within 8 days after hospitalization ]
    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

  10. To assess the feeling of the patient about cci-MR and the reference strategy [ Time Frame: Within 8 days after hospitalization ]
    Level of satisfaction of the patient about cci-MR and the reference strategy


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04790357


Contacts
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Contact: MECHTOUFF Laura, MD 04 27 85 67 47 laura.mechtouff@chu-lyon.fr
Contact: MANSUY Adeline O4 72 11 51 70 adeline.mansuy@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon
Bron, France, 69500
Contact: MANSUY ADELINE    04 72 11 51 70    adeline.mansuy@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Study Director: MECHTOUFF Laura, MD Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04790357    
Other Study ID Numbers: 69HCL17_0394
2020-A00071-38 ( Other Identifier: IDRCB )
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemic Attack, Transient
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis