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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Inpatients or outpatients with the cardiac device of interest implanted prior to enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| David J. Whellan, MD MHS FACC | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jefferson Heart Institute | Philadelphia | Pennsylvania | 19107 | United States |
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Subjects with Implanted Cardiac Defibrillators were enrolled from the Heart Institute Outpatient Clinic or from the inpatient Electrophysiology Lab at Thomas Jefferson University Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | ICD Event | Subjects who experienced a device treatment, defined as a pacing event or a shock event |
| FG001 | No ICD Event | Subjects who did not experience a treatment defined as a pacing event or a shock event |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analysis population was determined by the enrolled subjects for whom the MMP2 and MMP9 assays were completed.
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| ID | Title | Description |
|---|---|---|
| BG000 | ICD Pacing or Shock Event | Subjects who experienced a device treatment, defined as a pacing event or a shock event |
| BG001 | No ICD Pacing or Shock Event | Subjects who did not experience a treatment defined as a pacing event or a shock event |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | MMP-2 | Serum MMP-2 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis. | Posted | Mean | Standard Deviation | pg/ml | At time of enrollment |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ICD Pacing or Shock Event | Subjects who experienced a device treatment, defined as a pacing event or a shock event |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David J. Whellan MD | Thomas Jefferson University | 215 955 2636 | david.whellan@jefferson.edu |
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| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D017202 | Myocardial Ischemia |
| D001145 | Arrhythmias, Cardiac |
| D016757 | Death, Sudden, Cardiac |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
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Blood
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | MMP-9 | Serum MMP-9 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis. | Posted | Mean | Standard Deviation | pg/ml | At time of enrollment |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | No ICD Pacing or Shock Event | Subjects who did not experience a treatment defined as a pacing event or a shock event | 0 | 26 | 0 | 26 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
| D003643 | Death |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |