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

NCT04439942 | Completed

• 1 other identifier: PI2020_843_0047
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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

Keywords

Hypertrophic Cardiomyopathy; 4D-flow magnetic resonance imaging; Obstruction; maximal gradient; echocardiography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by phase-contrast

  day 1

Interventions

cardiac magnetic resonance imaging (MRI) OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Bites and Stings

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Cédric Renard, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 19, 2020
• Study Start: June 17, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)