Clinical trial NCT04439942: 4D-flow MRI to Assess Left Ventricular Obstruction in Hypertrophic Cardiomyopathy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertrophic Cardiomyopathy
Obstruction
Echocardiography
Keywords: Hypertrophic Cardiomyopathy
4D-flow magnetic resonance imaging
Obstruction
maximal gradient
echocardiography
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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.


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

Primary outcomes:
measure: Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by echocardiography.
timeFrame: day 1
Secondary outcomes:
measure: Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by phase-contrast
timeFrame: day 1
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Cédric Renard, MD
role: PRINCIPAL_INVESTIGATOR
References: