diagnostic flow
Otherexams to estimate the risk of adverse events in patients with MAD
NCT Number: NCT04916535
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
This study is active but is not currently recruiting participants.
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
University Hospital of Ferrara, Ferrara, Italy
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
exams to estimate the risk of adverse events in patients with MAD
Time frame: 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
Time frame: 5 years
occurrence of mitral surgery
Time frame: 5 years
occurrence of sudden cardiac death
Time frame: 5 years
occurrence of aborted cardiac arrest
Time frame: 5 years
occurrence of non-sustained and/or sustained ventricular tachycardia
University Hospital of Ferrara
Other
Observational Cohort Prospective Multicenter Study on Mitral Annular Disjunction (MAD) - MAD multiceNter Study (MAD-NesS)
Acronym: MAD-NesS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04147884
Cardiovascular Diseases, Mitral Regurgitation Functional
Tucson, Arizona, United States
View Trial DetailsNCT03339115
Cardiovascular Diseases, Heart Diseases
Bonn, North Rhine-Westphalia, Germany
View Trial DetailsNCT03193801
Cardiovascular Diseases, Heart Diseases
Atlanta, Georgia, United States
View Trial DetailsNCT03444259
Aortic Valve Disease, Aortic Valve Stenosis
Turku, Finland
View Trial Details