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

NCT ID: NCT04439942

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-17
• Study Completion Date: 2023-06-01

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.

Conditions

Hypertrophic Cardiomyopathy; Obstruction; Echocardiography

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cédric Renard, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

CHU Amiens

Amiens, , France

Countries

France

Other Identifiers

PI2020_843_0047

Identifier Type: -

Identifier Source: org_study_id