Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06436573
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-03-27
Brief Title:
Mitro-annular Disjunction in Cardiac Magnetic Resonance
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Mitro-annular Disjunction in Cardiac Magnetic Resonance
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Finally the association between MAD and arrhythmias will be investigated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None