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Multiparametric SCores for Prediction of Myocardial FIbrosis in Patients with MITral VAlve PRolapse (SCIMITAR)

C

Centro Cardiologico Monzino

Status

Enrolling

Conditions

Mitral Valve Prolapse

Study type

Observational

Funder types

Other

Identifiers

NCT06341166
CCM1959

Details and patient eligibility

About

This is a multicenter, observational prospective and retrospective study which aims are: 1) to compute a scoring model potentially predictive for the diagnosis of fibrosis by CMR in patients with MVP; 2) to identify specific features that may predispose to ≥ mild VAs or SCD in patients with MVP.

Full description

Patients with mitral valve prolapse and non-significant mitral regurgitation generally have a good prognosis. A minority of patients with MVP suffers from ventricular arrhythmias. Different demographic, clinical, and electrocardiographic characteristics, as well as morphological and structural features of the MV were described as potential risk factors for ventricular arrhythmias, among which fibrosis of the left ventricular inferolateral wall and posterior papillary muscle as detected by cardiac magnetic resonance.

As cardiac magnetic resonance has some limitations, it is unknown if and which patients with mitral valve prolapse should undergo cardiac magnetic resonance in routine clinical practice, to search for late gadolinium enhancement as a surrogate for myocardial fibrosis.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age ≥ 18 years
  • Echocardiographic diagnosis of mitral valve prolaspe, defined as a systolic displacement of one or both mitral leaflets ≥ 2 mm above the plane of the mitral valve annulus in long-axis views

Exclusion criteria

  • age< 18 years
  • coexistence of other cardiomyopathies or other ≥ moderate valve diseases
  • scarce acoustic transthoracic echocardiographic window
  • usual contraindications for cardiac magnetic resonance

Trial design

300 participants in 2 patient groups

Prospective Cohort
Description:
Prospectively enrolled patients will undergo a complete assessment, as clinically indicated, including clinical evaluation, TTE, rest ECG, 24h ECG-monitoring, and CMR. CMR will be performed no more than 6 months apart from other examinations (TTE, rest ECG, 24h ECG-monitoring).
Retrospective Cohort
Description:
Patients will be enrolled retrospectively, in case they have already performed all examinations between 2016 and 2023

Trial contacts and locations

1

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Central trial contact

Gianluca Pontone, MD

Data sourced from clinicaltrials.gov

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