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

NCT ID: NCT04790357

Last Updated: 2021-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-05-01

Brief Summary

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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

Detailed Description

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Conditions

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Ischemic Stroke Transient Ischemic Attack

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Reference strategy

correspond to the reference techniques according to the current guidelines in the etiological work up of ischemic strokes and TIA

Group Type OTHER

Current guidelines

Intervention Type 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

Evaluated strategy

correspond to perform the cci-MR: cardiac MRI with late-enhancement, angio-MRI of the cervical and intracranial arteries

Group Type OTHER

cc-MRI

Intervention Type OTHER

of one-shot cardiac-cervical-intracranial MRI: cardiac MRI with late-enhancement, angio-MRI of the cervical and intracranial arteries

Interventions

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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

Intervention Type OTHER

cc-MRI

of one-shot cardiac-cervical-intracranial MRI: cardiac MRI with late-enhancement, angio-MRI of the cervical and intracranial arteries

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MECHTOUFF Laura, MD

Role: STUDY_DIRECTOR

Hospices Civils de Lyon

Locations

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Hospices Civils de Lyon

Bron, , France

Site Status

Countries

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France

Central Contacts

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MECHTOUFF Laura, MD

Role: CONTACT

04 27 85 67 47

MANSUY Adeline

Role: CONTACT

O4 72 11 51 70

Facility Contacts

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MANSUY ADELINE

Role: primary

04 72 11 51 70

Other Identifiers

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2020-A00071-38

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL17_0394

Identifier Type: -

Identifier Source: org_study_id

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