Prospective Multicenter Study on Mitral Annular Disjunction
- Conditions
- Mitral Valve Disease
- Interventions
- Other: diagnostic flow
- Registration Number
- NCT04916535
- Lead Sponsor
- University Hospital of Ferrara
- Brief Summary
Observational cohort prospective multicenter study on patients with mitral annular disjunction (MAD). MAD is defined as a separation (≥1 mm) between the atrial wall-mitral valvular junction and the left ventricular free wall during end-systole
- Detailed Description
Mitral annular disjunction (MAD) is a structural abnormality of the mitral annulus, defined as a separation (≥1 mm) between the atrial wall-mitral valvular junction and the left ventricular free wall during end-systole. This abnormality is significantly associated with the presence of mitral valve prolapse (MVP), but it can also be observed in normal hearts. MAD-related hypermobility of the mitral apparatus and the consequent posterior systolic curling determine a mechanical stress of the infero-basal wall and papillary muscle. This phenomenon leads to myocardial hypertrophy and fibrosis, creating an arrhythmogenic substrate and a source of electrical instability. For this reason, the analysis of left ventricle by cardiac magnetic resonance plays a pivotal role in the identification of predictors of fatal arrhythmic events, such as sudden cardiac death (SCD). Taking into account that MAD could be present without MVP, some studies analyzed the association between MAD and arrhythmic events. They showed that MAD itself is a risk marker of electrical instability supporting the existence of an emerging clinical entity: the MAD arrhythmic syndrome. An in deep analysis of MAD patients and their characteristics in terms of EKG, types of arrhythmia, echocardiographic parameters and cardiac magnetic resonance (CMR) data and long-term events is lacking.
The present study is ideated and conducted to fill this gap and collect information regarding management and outcome of patients with MAD
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description diagnostic flow diagnostic flow all patients with MAD as assessed during routine transthoracic echocardiography will undergo to the following further exams: i) 12-lead electrocardiogram (ECG), ii) 24-hour ECG monitoring, iii) cardiac magnetic resonance imaging (CMR), iv) cardiological visit
- Primary Outcome Measures
Name Time Method Pathological findings associated with MAD 3 months Percentage of subjects with MAD whom deeper analysis with cardiological visit, electrocardiogram (ECG), 24-hour ECG Holter monitoring and cardiac magnetic resonance (CMR) identifies pathological findings. Pathological findings are defined as follows: -T wave inversion in inferolateral leads at ECG
* frequent premature ventricular complexes (\>1000/24h)
* non-sustained ventricular arrythmias
* sustained ventricular arrythmias
* severe mitral regurgitation
* myocardial fibrosis with a non-ischemic pattern, especially of papillary muscles and inferolateral wall. The primary endpoint will be considered achieved if at least one of the above mentioned paramentrs will be found in the patient
- Secondary Outcome Measures
Name Time Method surgery for mitral valve 5 years occurrence of mitral surgery
sudden cardiac death 5 years occurrence of sudden cardiac death
aborted cardiac arrest 5 years occurrence of aborted cardiac arrest
ventricular arrhythmia 5 years occurrence of non-sustained and/or sustained ventricular tachycardia
Trial Locations
- Locations (5)
Morgagni Hospital
🇮🇹Forlì, Italy
Cardiology Unit
🇮🇹Rimini, Italy
University Hospital of Ferrara
🇮🇹Ferrara, Italy
Santa Maria delle Croci Hospital
🇮🇹Ravenna, Italy
University Hospital fo Trieste
🇮🇹Trieste, Italy