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Dynamic Evaluation of Myocardial Fibrosis and Structural Determinants of Ventricular Arrhythmia in Mitral Valve Prolapse (STAMP-2 : STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2)
Led by Central Hospital, Nancy, France · Updated on 2022-08-09
280
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Mitral valve prolapse (MVP) is a common condition affecting the mitral valve, with a prevalence of 2-3% in the general population. While often considered benign, MVP can progress to mitral valve regurgitation and rhythm disturbances. Researchers are evaluating factors that may predict unfavorable outcomes such as ventricular remodeling or arrhythmias over three years in patients with MVP. This study is led by the Central Hospital in Nancy, France, and uses imaging and biomarkers to better understand the condition's progression. Participants are divided into groups based on the severity of mitral regurgitation and presence of ventricular extrasystoles. All will have assessments at the start and after 36 months, including recommended tests like echocardiography, 24-hour external loop recording, and exercise ECG. For research purposes, they will also undergo injected cardiac MRI with additional MRI sequences (4D flow) and blood collections, including genetics, to study myocardial changes and arrhythmia risks. Throughout the study, participants will be closely monitored with imaging and rhythm evaluations to track ventricular remodeling and arrhythmia occurrence. The main outcomes measured include the presence of ventricular remodeling and ventricular arrhythmias such as fibrillation, tachycardia, or extrasystoles at three years. This research involves no randomization or blinding, and participants are expected to undergo detailed testing at two timepoints over the three-year period.
CONDITIONS
Brief Title
STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 18 years old
- Diagnosed with mitral valve prolapse
- Provided informed consent after full information about the study
- Affiliated with or beneficiary of social security insurance
- Completed prior clinical examination with no contraindications to planned tests
You will not qualify if you...
- Severe mitral regurgitation requiring surgery
- Severe rhythm disorders needing a defibrillator implant
- Had an injected MRI within one month before the study MRI
- Known heart diseases causing myocardial damage that affect results interpretation
- Contraindications to MRI (e.g., pacemaker, defibrillator, implanted pump, cochlear implants, metallic foreign bodies)
- Claustrophobia or body type preventing MRI
- Motor or mental disability
- Renal impairment preventing gadolinium contrast injection
- Allergy to gadoteric acid, meglumine, or gadolinium drugs
- Women of childbearing age without effective contraception
- Persons restricted by specific public health code articles
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 - 36 months
Participants undergo injected cardiac MRI, prolongation of the MRI examination with a 4D flow sequence, blood collection including genetics, echocardiography, 24-hour external loop recording, and exercise ECG at inclusion and 36 months later to evaluate myocardial fibrosis and structural determinants of ventricular arrhythmia.
2 visits (at inclusion and 36 months)
Trial Site Locations
Total: 1 location
1
Nancy University Hospital
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
5
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