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

Hypertrophic Cardiomyopathy Clinical Trial

— CMHFLUX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04439942
• Other study ID #: PI2020_843_0047
• Status: Completed
• Start date: June 17, 2020
• Est. completion date: June 1, 2023

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Echocardiography
• Hypertrophic Cardiomyopathy
• Hypertrophy
• Obstruction

Intervention

Other:
• cardiac magnetic resonance imaging (MRI)
Cardiac MRI is a mandatory examination for Hypertrophic cardiomyopathy patients as it provides important information about the presence of fibrosis which is also directly associated with sudden cardiac death.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by echocardiography.	Correlation coefficient assessment between the maximum gradient obtained by 4D flow	day 1
Secondary	Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by phase-contrast	Correlation coefficient assessment between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by phase-contrast	day 1