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The purpose of the proposed pilot study is to identify factors which are associated with periods of high ventricular arrhythmia burden. This will be performed by analysis of gene expression from peripheral blood samples.
This is a study of patients with ICD implants who present with multiple(>2), low-level(1-2) or inappropriate therapies to their defibrillator. The purpose of this pilot study is to identify factors which are associated with periods of high ventricular arrhythmia burden by looking at gene expression from peripheral blood, in addition to levels of known markers of CHF, including catecholamine levels, B-type natriuretic peptide, and troponin. This study hypothesizes that extrinsic or systemic factors play a role in triggering these events, and if true should yield candidate proteins which would spawn functional studies to prove a role in causation. Additionally, identification of a marker of increased recurrence of events may aid in guiding therapy (starting an anti-arrhythmic versus awaiting the next event).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Forty(40)subjects that have received >2 appropriate ICD shock therapies |
| |
| 2 | Twenty(20)subjects that have received 1-2(low level)appropriate ICD therapies |
| |
| 3 | Ten(10)subjects that received inappropriate therapies from their ICD |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripheral blood sampling | Procedure | blood samples will be collected within 72 hours of subjects receiving >2, 1-2(low level) or inappropriate therapies, device data and repeat bloodwork in 3 months(+/- 4weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Genetic Testing | Identification of factors which are associated with periods of high ventricular arrhythmia burden (Day 1) by looking at gene expression from peripheral blood, in addition to levels of known markers of congestive heart failure (catecholamine levels, B-type natriuretic peptide, and troponin)in comparison to subject's return to own normal state (3 month +/- 30 days) | Day 1 Enrollment |
| Genetic Testing | Identification of factors which are associated with periods of high ventricular arrhythmia burden (Day 1) by looking at gene expression from peripheral blood, in addition to levels of known markers of congestive heart failure (catecholamine levels, B-type natriuretic peptide, and troponin)in comparison to subject's return to own normal state (3 month +/- 30 days) | Day 90 +/- 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Thirty men and women over age 18 with electrical strom that we hope will volunteer to participate in this genetic research study
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| Name | Affiliation | Role |
|---|---|---|
| Sandeep K. Jain, M.D. | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | United States | ||
| UPMC Shadyside Hospital |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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6 RNA samples are obtained and kept frozen on-site to be evalauted at a later date. A portion of this DNA will be used to analyze the structure of certain genes that are known to play a role in cardiac arrhythmias. We cannot at this time know exatly what genes will be tested.
| Pittsburgh |
| Pennsylvania |
| 15216 |
| United States |