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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00376532
Other study ID # TJU 06U.282
Secondary ID
Status Completed
Phase N/A
First received September 14, 2006
Last updated May 5, 2014
Start date September 2006
Est. completion date September 2008

Study information

Verified date May 2014
Source Thomas Jefferson University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Description:

Sudden cardiac death (SCD) is responsible for 300,000-450,000 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 patient's 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.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- LVEF of = 35% measured within 6 months of ICD implantation

- NYHA class II-IV at the time of ICD implantation

- ICD implantation at least 1 year prior to enrollment

Exclusion Criteria:

- Status post heart transplant

- Known malignancy in the past 2 years.

- Recent procedure, intervention or surgery within the past 90 days

- Acute MI, CABG, or PTCA/stent within the past 2 months.

- Active rheumatoid arthritis or pulmonary or hepatic fibrosis.

- Taking chronic steroid therapy for a medical condition

- Currently pregnant

- Enrolled in a concurrent study that may confound the results of this study

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
United States Jefferson Heart Institute Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Thomas Jefferson University Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary MMP-2 Serum MMP-2 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis. At time of enrollment No
Primary MMP-9 Serum MMP-9 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis. At time of enrollment No
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