Arrythmia Clinical Trial
— EMMAOfficial 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.
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 |
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.
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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Jefferson Heart Institute | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University | Medtronic |
United States,
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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