- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06436573
Mitro-annular Disjunction in Cardiac Magnetic Resonance
Mitral annular disjunction (MAD) is an abnormal atrial displacement of the mitral valve leaflet hinge point. MAD is gaining clinical importance for several studies reporting its association to mitral valve prolapse (MVP), complex ventricular arrhythmias and sudden cardiac death.
On the other hand, other studies found MAD as an extremely diffuse anatomical variant of mitral valve annulus without any pathological implication.
Cardiac Magnetic Resonance is the non-invasive gold standard for myocardial characterization, with the possibility of accurate anatomical and functional evaluation associated to the evaluation of focal and interstitial fibrosis, resulting useful in the identification of arrhythmic substrate and for patients risk stratification. Additionally, Cardiac Magnetic Resonance (CMR) was found to be superior to echocardiography not only in term of tissue characterization, but also in the identification of small MAD.
Therefore, in relation to the scarcity of data about MAD prevalence and pathological potential, we set a large multicenter retrospective study aimed to evaluate prevalence of MAD in patients submitted to CMR independently by the clinical suspicion, and to evaluate the association with prolapse and arrhythmias.
Study Overview
Status
Detailed Description
Multicenter retrospective study. All cardiac MRI study obtained during the first semester of 2019 will be screened in order to identify the presence and severity of MAD, it association to other myocardial condition such as bileaflet mitral valve prolapse, miltral regurgitation, curling, and focal and interstitial fibrosis at LGE and ECV evaluation.
Finally, the association between MAD and arrhythmias will be investigated.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Milan, Italy, 20132
- IRCCS San Raffaele
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Retrospective cohort
Consecutive adult patients (age ≥18 years-old), submitted to Cardiac Magnetic Resonance independently by the clinical suspicions in the first semester of 2019 (from January to June 2019) that have signed an Informed Consent authorizing data collection for future retrospective clinical research protocols. Timelapse has been chosen to avoid the impact of COVID-19 pandemic. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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the outcome will be the presence of MAD
Time Frame: 1 year
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The main objective of the present study is to investigate the prevalence of MAD in a large population undergoing CMR independently by the clinical suspicion.
Therefore, the endpoint will be the prevalence of MAD in the examined population and the outcome will be the presence of MAD.
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Antonio Esposito, MD, IRCCS San Raffaele Institute
Publications and helpful links
General Publications
- Kulkarni AA, Chudgar PD, Burkule NJ, Kamat NV. Mitral Annulus Disjunction and Arrhythmic Mitral Valve Prolapse: Emerging Role of Cardiac Magnetic Resonance Imaging in the Workup. Indian J Radiol Imaging. 2022 Aug 30;32(4):576-581. doi: 10.1055/s-0042-1754357. eCollection 2022 Dec.
- Bennett S, Thamman R, Griffiths T, Oxley C, Khan JN, Phan T, Patwala A, Heatlie G, Kwok CS. Mitral annular disjunction: A systematic review of the literature. Echocardiography. 2019 Aug;36(8):1549-1558. doi: 10.1111/echo.14437. Epub 2019 Aug 5.
- Chess RJ, Mazur W, Palmer C. Stop the Madness: Mitral Annular Disjunction. CASE (Phila). 2023 Jan 18;7(3):116-118. doi: 10.1016/j.case.2022.12.004. eCollection 2023 Mar.
- Faletra FF, Leo LA, Paiocchi VL, Schlossbauer SA, Pavon AG, Ho SY, Maisano F. Morphology of Mitral Annular Disjunction in Mitral Valve Prolapse. J Am Soc Echocardiogr. 2022 Feb;35(2):176-186. doi: 10.1016/j.echo.2021.09.002. Epub 2021 Sep 8.
- Bennett S, Tafuro J, Duckett S, Appaji A, Khan JN, Heatlie G, Cubukcu A, Kwok CS. Definition, prevalence, and clinical significance of mitral annular disjunction in different patient cohorts: A systematic review. Echocardiography. 2022 Mar;39(3):514-523. doi: 10.1111/echo.15299. Epub 2022 Feb 4.
- Dejgaard LA, Skjolsvik ET, Lie OH, Ribe M, Stokke MK, Hegbom F, Scheirlynck ES, Gjertsen E, Andresen K, Helle-Valle TM, Hopp E, Edvardsen T, Haugaa KH. The Mitral Annulus Disjunction Arrhythmic Syndrome. J Am Coll Cardiol. 2018 Oct 2;72(14):1600-1609. doi: 10.1016/j.jacc.2018.07.070.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAD-SIRM
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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