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| Sponsor: | University of Pittsburgh |
|---|---|
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00284453 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Arrhythmias |
Procedure: Peripheral blood sampling |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Gene Expression in ICD Patients With Electrical Storm |
2 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.
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | October 2010 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Subjects that have received >2 appropriate ICD shock therapies
|
Procedure: Peripheral blood sampling
blood samples will be collected within 72 hours of subjects receiving >2 shock therapies and at 3 month follow-up MD appointment
|
|
2
Subjects that have received >2 inappropriate ICD shock therapies
|
Procedure: Peripheral blood sampling
blood samples will be collected within 72 hours of subjects receiving >2 shock therapies and at 3 month follow-up MD appointment
|
This is a study of patients with ICD implants who present with multiple shocks, termed electrical storm. 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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Thirty men and women over age 18 with electrical strom that we hope will volunteer to participate in this genetic research study
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Sandeep K. Jain, M.D. | 412-647-6272 | jainsk@upmc.edu |
| Contact: Pamela M. White, BSN | 412-647-2931 | whitepm@upmc.edu |
| United States, Pennsylvania | |
| UPMC Presbyterian Hospital | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: Sandeep Jain, M.D. | |
| UPMC Shadyside Hospital | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15216 | |
| Principal Investigator: Sandeep K. Jain, M.D. | |
| Principal Investigator: | Sandeep K. Jain, M.D. | University of Pittsburgh |
More Information
| Responsible Party: | University of Pittsburgh Cardiovascular Institute-Electrophysiology Department ( Sandeep Jain, MD ) |
| Study ID Numbers: | 0510087 |
| Study First Received: | January 27, 2006 |
| Last Updated: | February 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00284453 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
ventricular arrhythmias ICD VT storm ICD patients with VT storm |
|
Pathologic Processes Heart Diseases Tachycardia |
Cardiovascular Diseases Tachycardia, Ventricular Arrhythmias, Cardiac |