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

NCT04790357 | Unknown

• 2 other identifiers: 69HCL17_03942020-A00071-38
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

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

Conditions

Ischemic Stroke; Transient Ischemic Attack

Outcome Measures

Primary Outcomes (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

  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 Outcomes (10)

• To assess the reproducibility of the assessment of the cci-MR results

  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.

  Within 8 days after hospitalization

• To assess the improvement of the detection of myocardial scar with cci-MR compared to reference strategy

  Within 8 days after hospitalization

• To assess the atherosclerotic burden (coronary, intracranial, cervical, aortic) assessed with cci-MR compared to the reference strategy,

  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.)

  Within 8 days after hospitalization

Study Arms (2)

Reference strategy

OTHER

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

Other: Current guidelines

Evaluated strategy

OTHER

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

Other: cc-MRI

Interventions

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

Reference strategy

cc-MRI OTHER

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

Evaluated strategy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or woman aged from 18 to 85 years old,
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Bron, 69500, France

Location

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Study Officials

• MECHTOUFF Laura, MD

  Hospices Civils de Lyon

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: March 10, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)