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

March 5, 2021 updated by: Hospices Civils de Lyon
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
244

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 81 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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
Within 8 days after hospitalization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
Time Frame: Within 8 days after hospitalization
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
Time Frame: Within 8 days after hospitalization
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,
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.
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.)
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
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
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
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
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
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
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
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)
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
Within 8 days after hospitalization
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
Within 8 days after hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MECHTOUFF Laura, MD, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings