4D-flow MRI to Assess Left Ventricular Obstruction in Hypertrophic Cardiomyopathy (CMHFLUX)

August 22, 2023 updated by: Centre Hospitalier Universitaire, Amiens

4D Flow Cardiac MRI Velocity Mapping in Patients With Hypertrophic Cardiomyopathy: Assessment of the Severity of the Left Ventricular Obstruction and Comparison With Echocardiography

Hypertrophic cardiomyopathy (HCM) is a frequent cardiac pathology with an estimated prevalence of 1/500 in France. The main risk factor for sudden death in this pathology is the presence and extent of left ventricular obstruction. To date, the only method allowing a reliable assessment of the extent of left ventricular obstruction is Doppler echocardiography. All patients with HCM should undergo cardiac magnetic resonance imaging (MRI) to confirm the diagnosis and for the detection of fibrosis, but conventional sequences cannot reliably assess the obstruction. 4D-flow MRI provides a complete coverage of an entire volume with the ability to simultaneously measure the outputs of all vessels within that volume in a single sequence and might be able to quantify left ventricular obstruction.

The main objective of this study is to compare the quantification of left ventricular obstruction in hypertrophic cardiomyopathy by Doppler echocardiography and 4D flow MRI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

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

Study Locations

  • France
      • Amiens, France, 80480
        • CHU Amiens

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with Hypertrophic cardiomyopathy will undergo Doppler-echocardiography followed promptly (within the same hour) by a complete cardiac MRI with the addition of a 4D Flow sequence (does not require the injection of a contrast agent and does not prolong the duration of the examination).

Description

Inclusion Criteria:

  • Age ≥ 18 years old
  • Presence of a Hypertrophic cardiomyopathy (HCM)
  • Affiliation to a social security program
  • Ability of the subject to understand and express opposition

Exclusion Criteria:

  • Major obesity (> 140 kg) not allowing the patient to enter the tunnel of the machine whose diameter is less than 70cm,
  • Age < 18,
  • Person under guardianship or curators,
  • Pregnant woman,
  • Allergy to gadolinium chelates,
  • Claustrophobia,
  • Any contraindications to MRI

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by echocardiography.
Time Frame: day 1
Correlation coefficient assessment between the maximum gradient obtained by 4D flow
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by phase-contrast
Time Frame: day 1
Correlation coefficient assessment between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by phase-contrast
day 1

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Cédric Renard, MD, CHU Amiens

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 (Actual)

June 17, 2020

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

June 18, 2020

First Submitted That Met QC Criteria

June 18, 2020

First Posted (Actual)

June 19, 2020

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2020_843_0047

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.

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