Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04852731

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

On this page

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

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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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