## Protocol Section
### Identification Module
**NCT ID:** NCT06436573

**Brief Title:** Mitro-annular Disjunction in Cardiac Magnetic Resonance

**Official Title:** Mitro-annular Disjunction in Cardiac Magnetic Resonance

#### Organization Study ID Info
**ID:** MAD-SIRM
#### Organization
**Class:** OTHER
**Full Name:** IRCCS San Raffaele
### Status Module
#### Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-28

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-03-27
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** IRCCS San Raffaele

#### Responsible Party

**Investigator Affiliation:** IRCCS San Raffaele

**Investigator Full Name:** Antonio Esposito

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

**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.

### Conditions Module

**Conditions:**

- Mitral Valve Prolapse Syndrome

- Arrhythmogenic Bileaflet Mitral Prolapse

- Mitral Valve Disorder

**Keywords:**

- Mitral annular disjunction, mitral prolapse, arrhthymia

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 4000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Label:** Retrospective cohort

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** the outcome will be the presence of MAD

**Time Frame:** 1 year

### Eligibility Module

**Eligibility 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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Consecutive adult patients (age ≥18 years-old), submitted to Cardiac Magnetic Resonance independently by the clinical suspicions in the first semesterof 2019 (from January to June 2019)

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** esposito.antonio@hsr.it

**Name:** Antonio Esposito

**Phone:** 0226436102

**Role:** CONTACT

**Contact 2:**

**Email:** palmisano.anna@hsr.it

**Name:** Anna Palmisano, MD, PhD

**Phone:** 0226432489

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** IRCCS San Raffaele Institute

**Name:** Antonio Esposito, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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.

**PMID:** 36451946

**Citation:** 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.

**PMID:** 31385360

**Citation:** 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.

**PMID:** 37065832

**Citation:** 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.

**PMID:** 34508838

**Citation:** 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.

**PMID:** 35122307

**Citation:** 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.

**PMID:** 30261961

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000016127

- Term: Heart Valve Prolapse

- ID: D000006349

- Term: Heart Valve Diseases

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M11911

- Name: Mitral Valve Prolapse

- Relevance: HIGH

- As Found: Mitral Valve Prolapse

- ID: M14261

- Name: Prolapse

- Relevance: HIGH

- As Found: Prolapse

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M9437

- Name: Heart Valve Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008945

- Term: Mitral Valve Prolapse

- ID: D000011391

- Term: Prolapse

### Misc Info Module

- Version Holder: 2024-05-31
