Actively Recruiting
Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse: the SCIMITAR Trial
Led by Centro Cardiologico Monzino · Updated on 2026-02-03
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Centro Cardiologico Monzino
Lead Sponsor
H
Humanitas Hospital, Italy
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to develop a scoring model to predict myocardial fibrosis detected by cardiac magnetic resonance (CMR) in patients with mitral valve prolapse (MVP). It also seeks to identify features that may increase the risk of mild ventricular arrhythmias or sudden cardiac death in these patients. MVP patients typically have a good outlook, but a small group may experience dangerous heart rhythm problems, which this study investigates. The study includes two groups: patients enrolled prospectively who will undergo a full clinical assessment including echocardiography, resting ECG, 24-hour ECG monitoring, and CMR within six months of each other; and patients enrolled retrospectively who have already completed these examinations between 2016 and 2023. This observational study collects detailed clinical and imaging data to explore links between heart structure, function, and rhythm abnormalities. Participants will be evaluated using various tests such as transthoracic echocardiography, ECG monitoring, and CMR to measure heart structure and scarring. Researchers will analyze these data to predict fibrosis and risk of arrhythmias or sudden cardiac death. The study will monitor outcomes through June 2026, focusing on clinical, echocardiographic, ECG, and CMR parameters to improve understanding of risk factors in MVP patients.
CONDITIONS
Brief Title
Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Echocardiographic diagnosis of mitral valve prolapse, defined as systolic displacement of one or both mitral leaflets 2 mm or more above the mitral valve annulus plane in long-axis views
You will not qualify if you...
- Age under 18 years
- Presence of other cardiomyopathies or moderate or worse valve diseases
- Poor acoustic window for transthoracic echocardiography
- Standard contraindications for cardiac magnetic resonance imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants undergo clinical evaluation, transthoracic echocardiography (TTE), resting ECG, 24-hour ECG monitoring, and cardiac magnetic resonance imaging (CMR) to assess myocardial fibrosis and ventricular arrhythmias.
1 to 2 visits depending on assessments
Duration - Up to study completion in June 2026
Participants are observed for clinical outcomes including ventricular arrhythmias and cardiac events based on collected diagnostic data.
Follow-up visits as needed
Trial Site Locations
Total: 1 location
1
Centro Cardiologico Monzino
Milan, Milan, Italy, 20131
Actively Recruiting
Research Team
G
Gianluca Pontone, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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