Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00376532
Status:
COMPLETED
Last Update Posted:
2014-06-04
First Post:
2006-09-14
Brief Title:
Extracellular Matrix Marker of Arrhythmia Risk EMMA
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
Role of Matrix MetaloproteinaseMMP9 and MMP 2 in Risk Stratification for Ventricular TachycardiaFibrillation in Patients With Implanted Cardioverter Defibrillator ICD Devices
Status:
COMPLETED
Status Verified Date:
2014-05
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:
EMMA
Brief Summary:
Assess whether serum levels of MMP 2 and or MMP 9 correlate with episodes of ventricular tachycardia or fibrillation in patients who have implantable cardioverter defibrillator devices
Detailed Description:
Sudden cardiac death SCD is responsible for 300000-450000 deaths per year in the United States While it is well known that patients with both ischemic and non-ischemic cardiomyopathy ICM NICM are at increased risk for SCD there is little beyond ejection fraction which has proven useful as a noninvasive predictor to risk stratify these patients
Myocardial scar has been validated as an arrhythmic substrate in ischemic populations the majority of successful ablations for lethal ventricular arrhythmias are performed on tissues in peri-infarct regions Scar provides an anatomic electrical boundary where peri-infarct zones may lead to areas of slow conduction due to the disruption of inter-myocyte electrical conduction
Myocardial scar is a less organized collagen deposition which disrupts the typical cardiac extracellular matrix The collagen matrix provides mechanical support to the myocardium dictating ventricular shape size and stiffness While typically relatively dormant the fibrillar collagen matrix reflects a dynamic relationship between collagen synthesis mediated by fibroblasts and collagen degradation performed by matrix metalloproteinases MMP
A marker for scar burden or a marker which could assess a patients predilection to form scar after either an ischemic or non-ischemic insult may be useful in further risk stratifying this population Since MMP levels may fluctuate in the course of ischemic or nonischemic injury a static promoter sequence which confers a higher level of MMP expression to an ischemic or nonischemic insult may prove to be a reliable marker Functional polymorphisms of the MMP-9 gene promoters have been shown in multivariate analysis to be an independent predictor of cardiac mortality regardless of the mechanism of heart failure
Myocardial scar has been validated as an arrhythmic substrate in ischemic populations the majority of successful ablations for lethal ventricular arrhythmias are performed on tissues in peri-infarct regions Scar provides an anatomic electrical boundary where peri-infarct zones may lead to areas of slow conduction due to the disruption of inter-myocyte electrical conduction
Myocardial scar is a less organized collagen deposition which disrupts the typical cardiac extracellular matrix The collagen matrix provides mechanical support to the myocardium dictating ventricular shape size and stiffness While typically relatively dormant the fibrillar collagen matrix reflects a dynamic relationship between collagen synthesis mediated by fibroblasts and collagen degradation performed by matrix metalloproteinases MMP
A marker for scar burden or a marker which could assess a patients predilection to form scar after either an ischemic or non-ischemic insult may be useful in further risk stratifying this population Since MMP levels may fluctuate in the course of ischemic or nonischemic injury a static promoter sequence which confers a higher level of MMP expression to an ischemic or nonischemic insult may prove to be a reliable marker Functional polymorphisms of the MMP-9 gene promoters have been shown in multivariate analysis to be an independent predictor of cardiac mortality regardless of the mechanism of heart failure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None