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

NCT ID: NCT06341166

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-19
• Study Completion Date: 2025-06-19

Brief Summary

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.

Detailed 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.

Conditions

Mitral Valve Prolapse

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Prospective Cohort

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).

No interventions assigned to this group

Retrospective Cohort

Patients will be enrolled retrospectively, in case they have already performed all examinations between 2016 and 2023

No interventions assigned to this group

Eligibility Criteria

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

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

Sponsors

Humanitas Hospital, Italy

OTHER

Sponsor Role: collaborator

IRCCS Ospedale San Raffaele

OTHER

Sponsor Role: collaborator

Azienda Ulss 2 Marca Trevigiana

OTHER

Sponsor Role: collaborator

Centro Cardiologico Monzino

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro Cardiologico Monzino

Milan, Milan, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Gianluca Pontone, MD

Role: CONTACT

gianluca.pontone@cardiologicomonzino.it

0258002574 ext. +39

Facility Contacts

Chiara Centenaro

Role: primary

chiara.centenaro@cardiologicomonzino.it

0258002031 ext. +39

Other Identifiers

CCM1959

Identifier Type: -

Identifier Source: org_study_id