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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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Civil Hospices of Lyon

Status

Unknown

Conditions

Ischemic Stroke
Transient Ischemic Attack

Treatments

Other: Current guidelines
Other: cc-MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT04790357
69HCL17_0394
2020-A00071-38 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

244 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

244 participants in 2 patient groups

Reference strategy
Other group
Description:
correspond to the reference techniques according to the current guidelines in the etiological work up of ischemic strokes and TIA
Treatment:
Other: Current guidelines
Evaluated strategy
Other group
Description:
correspond to perform the cci-MR: cardiac MRI with late-enhancement, angio-MRI of the cervical and intracranial arteries
Treatment:
Other: cc-MRI

Trial contacts and locations

1

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Central trial contact

MANSUY Adeline; MECHTOUFF Laura, MD

Data sourced from clinicaltrials.gov

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