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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00376532
Recruitment Status : Completed
First Posted : September 15, 2006
Results First Posted : June 4, 2014
Last Update Posted : June 4, 2014
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Thomas Jefferson University

Study Description
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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.

Condition or disease
Myocardiopathies Ischemia, Myocardial Arrythmia Death, Sudden, Cardiac

Detailed 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.

Study Design
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Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Role of Matrix Metaloproteinase(MMP)9 and MMP 2 in Risk Stratification for Ventricular Tachycardia/Fibrillation in Patients With Implanted Cardioverter Defibrillator (ICD) Devices.
Study Start Date : September 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. MMP-2 [ Time Frame: At time of enrollment ]
    Serum MMP-2 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.

  2. MMP-9 [ Time Frame: At time of enrollment ]
    Serum MMP-9 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.


Biospecimen Retention:   Samples Without DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inpatients or outpatients with the cardiac device of interest implanted prior to enrollment.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376532


Locations
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United States, Pennsylvania
Jefferson Heart Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Medtronic
Investigators
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Principal Investigator: David J. Whellan, MD MHS FACC Thomas Jefferson University
More Information
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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00376532    
Other Study ID Numbers: TJU 06U.282
First Posted: September 15, 2006    Key Record Dates
Results First Posted: June 4, 2014
Last Update Posted: June 4, 2014
Last Verified: May 2014
Keywords provided by Thomas Jefferson University:
Cardiac Ischemia
Cardiac Arrhythmia
Defibrillator
Matrix Metalloproteinase
Genetic Polymorphism
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Death, Sudden, Cardiac
Cardiomyopathies
Myocardial Ischemia
Ischemia
Death, Sudden
 Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Death
Heart Arrest
Vascular Diseases