Extracellular Matrix Marker of Arrhythmia Risk (EMMA)

NCT00376532 | Completed Results

• 1 other identifier: TJU 06U.282
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardiopathies; Ischemia, Myocardial; Arrythmia; Death, Sudden, Cardiac

Keywords

Cardiac Ischemia; Cardiac Arrhythmia; Defibrillator; Matrix Metalloproteinase; Genetic Polymorphism

Outcome Measures

Primary Outcomes (2)

• MMP-2

  Serum MMP-2 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.

  At time of enrollment

• MMP-9

  Serum MMP-9 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.

  At time of enrollment

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients or outpatients with the cardiac device of interest implanted prior to enrollment.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Medtronic: collaborator

Study Sites (1)

Jefferson Heart Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Cardiomyopathies; Myocardial Ischemia; Arrhythmias, Cardiac; Death, Sudden, Cardiac; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: David J. Whellan MD
• Organization: Thomas Jefferson University

david.whellan@jefferson.edu

215 955 2636

Study Officials

• David J. Whellan, MD MHS FACC

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2006
• First Posted: September 15, 2006
• Study Start: September 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: June 4, 2014
• Results First Posted: June 4, 2014

Record last verified: 2014-05

Locations

US (1)