Observational study on mitral annular disjunction
Observational Cohort Prospective Multicenter Study on Mitral Annular Disjunction (MAD) - MAD MulticeNter Study (MAD-NesS)
This study looks at patients with mitral annular disjunction to see how it affects heart rhythm and overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital of Ferrara Academic / other |
| Locations | 7 sites (Bologna and 6 other locations) |
| Trial ID | NCT04916535 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to investigate patients with mitral annular disjunction (MAD), a structural abnormality associated with mitral valve prolapse and potential arrhythmic events. The study will analyze the relationship between MAD and electrical instability through detailed assessments including EKG, echocardiography, and cardiac magnetic resonance imaging. By collecting comprehensive data on patient characteristics and long-term outcomes, the study seeks to enhance understanding of MAD and its implications for patient management.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 who have been diagnosed with mitral annular disjunction during routine echocardiography.
Not a fit: Patients who refuse to participate or are outside the age range of 18 to 65 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the identification and management of patients at risk for arrhythmic events related to mitral annular disjunction.
How similar studies have performed: While there have been studies on mitral valve prolapse, the specific focus on mitral annular disjunction and its arrhythmic implications is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Subject aged ≥18 years and \<65 years * Evidence of MAD during routine echocardiography clinically indicated by treating physician for any reason * Written informed consent Exclusion criteria: • Patient's refusal
Where this trial is running
Bologna and 6 other locations
- Cardiology Unit — Bologna, Italy (Recruiting)
- University Hospital of Ferrara — Ferrara, Italy (Recruiting)
- Morgagni Hospital — Forlì, Italy (Recruiting)
- Cardiology Unit — Palermo, Italy (Recruiting)
- Santa Maria delle Croci Hospital — Ravenna, Italy (Recruiting)
- Cardiology Unit — Rimini, Italy (Recruiting)
- University Hospital fo Trieste — Trieste, Italy (Recruiting)
Study contacts
- Principal investigator: Elisabetta Tonet, MD — University Hospital of Ferrara
- Study coordinator: Chiara Manzalini, BsC
- Email: chiara88manzalini@gmail.com
- Phone: 0532239898
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.