Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse

Mitral Valve Prolapse Clinical Trial

— SCIMITAR  

Official title:

Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse: the SCIMITAR Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06341166
• Other study ID #: CCM1959
• Status: Recruiting
• Start date: June 19, 2023
• Est. completion date: June 19, 2025

Study information

• Verified date: March 2024
• Source: Centro Cardiologico Monzino
• Contact: Gianluca Pontone, MD
• Phone: 0258002574
• Email: gianluca.pontone[@]cardiologicomonzino.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 19, 2025
• Est. primary completion date: June 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Valve Prolapse
• Prolapse

Locations

Country	Name	City	State
Italy	Centro Cardiologico Monzino	Milan

Sponsors (4)

Lead Sponsor	Collaborator
Centro Cardiologico Monzino	Humanitas Hospital, Italy, IRCCS Ospedale San Raffaele, Treviso Regional Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction of fibrosis by CMR	Clinical, echocardiographic, electrocardiographic, and 24h-ECG monitoring variables will be collected in order to identify potential predictors of fibrosis as detected by cardiac magnetic resonance (CMR).; Specifically, the following parameters will be collected.; Clinical data: Transthoracic echocardiography parameters: Rest ECG parameters: 24h electrocardiographic monitoring parameters: Ventricular arrhythmias (VAs) will be classified as suggested in the recently published EHRA consensus statement; CMR parameters, applying the protocol of the Society of Cardiovascular Magnetic Resonance	June 2026
Secondary	Prediction of = mild Ventricular Arrhythmias and/or Sudden cardiac death in mitral valve	Clinical, echocardiographic, electrocardiographic, and CMR variables will be collected in order to identify potential predictors of =mild VAs, as defined by the recently published EHRA consensus document.; An accurate description of these variables and the Units of Measure are the same as those reported in the section "Primary Outcome Measures".	June 2026