Investigating Mitral Annular Disjunction using Cardiac MRI
Mitro-annular Disjunction in Cardiac Magnetic Resonance
This study is trying to see how common and serious mitral annular disjunction is in adults who had heart scans, and how it relates to heart valve problems and irregular heartbeats.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milano) |
| Trial ID | NCT06436573 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the presence and severity of mitral annular disjunction (MAD) in adult patients who underwent cardiac magnetic resonance imaging (CMR) during the first half of 2019. It will analyze the association of MAD with mitral valve prolapse, mitral regurgitation, and arrhythmias, while also assessing myocardial conditions through advanced imaging techniques. The study seeks to clarify the clinical significance of MAD, which has been linked to serious cardiac events in some reports but may also be a benign anatomical variant in others.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 and older who underwent cardiac MRI for clinical reasons between January and June 2019.
Not a fit: Patients under 18 years old, those with cardiac devices, previous mitral valve surgery, or insufficient imaging data will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of mitral annular disjunction and its implications for arrhythmia risk, potentially leading to better patient management.
How similar studies have performed: While there is limited data on MAD, other studies have shown varying results regarding its clinical significance, indicating that this investigation may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Consecutive adult patients (age ≥18 years-old), submitted to Cardiac Magnetic Resonance independently by the clinical suspicions in the first 6 month of 2019 (from January to June 2019) that have signed an Informed Consent authorizing data collection for future retrospective clinical research protocols Exclusion Criteria: • Pediatric patients (age \<18 years-old), cardiac devices (implantable devices), previous mitral valve surgery, lack of LGE images, lack of clinical information about presence of arrhythmias. The timeline was selected to avoid the impact of COVID-19 pandemic on CMR availability, scheduling, and findings.
Where this trial is running
Milano
- IRCCS San Raffaele — Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Antonio Esposito, MD — IRCCS San Raffaele Institute
- Study coordinator: Antonio Esposito
- Email: esposito.antonio@hsr.it
- Phone: 0226436102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.