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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04439942
Acronym
CMHFLUX
Enrollment
26
Registered
2020-06-19
Start date
2020-06-17
Completion date
2023-06-01
Last updated
2023-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Echocardiography, Hypertrophic Cardiomyopathy, Obstruction

Keywords

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

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.

Interventions

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.

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by phase-contrastday 1Correlation coefficient assessment between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by phase-contrast

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026