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

Completed

• Conditions: Hypertrophic Cardiomyopathy; Echocardiography; Obstruction

• Registration Number: NCT04439942
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-17
• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-19
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by echocardiography.	day 1	Correlation coefficient assessment between the maximum gradient obtained by 4D flow

Secondary Outcome Measures

Name	Time	Method
Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by phase-contrast	day 1	Correlation coefficient assessment between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by phase-contrast

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France