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Extracellular Matrix Marker of Arrhythmia Risk (EMMA) (EMMA)

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ClinicalTrials.gov Identifier: NCT00376532
Recruitment Status : Completed
First Posted : September 15, 2006
Results First Posted : June 4, 2014
Last Update Posted : June 4, 2014
Information provided by (Responsible Party):
Thomas Jefferson University

September 14, 2006
September 15, 2006
May 5, 2014
June 4, 2014
June 4, 2014
September 2006
September 2008   (Final data collection date for primary outcome measure)
  • MMP-2 [ Time Frame: At time of enrollment ]
    Serum MMP-2 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.
  • MMP-9 [ Time Frame: At time of enrollment ]
    Serum MMP-9 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.
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Complete list of historical versions of study NCT00376532 on ClinicalTrials.gov Archive Site
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Extracellular Matrix Marker of Arrhythmia Risk (EMMA)
Role of Matrix Metaloproteinase(MMP)9 and MMP 2 in Risk Stratification for Ventricular Tachycardia/Fibrillation in Patients With Implanted Cardioverter Defibrillator (ICD) Devices.
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.

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.

Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples Without DNA
Non-Probability Sample
Inpatients or outpatients with the cardiac device of interest implanted prior to enrollment.
  • Myocardiopathies
  • Ischemia, Myocardial
  • Arrythmia
  • Death, Sudden, Cardiac
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  • ICD pacing or shock event
    Subjects who experienced a device treatment, defined as a pacing event or a shock event
  • No ICD pacing or shock event
    Subjects who did not experience a treatment defined as a pacing event or a shock event
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2008
September 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
TJU 06U.282
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Thomas Jefferson University
Thomas Jefferson University
Principal Investigator: David J. Whellan, MD MHS FACC Thomas Jefferson University
Thomas Jefferson University
May 2014