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| Sponsored by: |
University of Pittsburgh |
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00284453 |
Purpose
This is a study of ICD patients receiving multiple therapies from defibrillators that seeks to find triggers for such events and identification of markers that may aid in guiding therapy.
| Condition | Intervention |
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Arrhythmias |
Procedure: Peripheral blood sampling |
| Genetics Home Reference related topics: | Brugada syndrome short QT syndrome |
| MedlinePlus related topics: | Arrhythmia |
| 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 2009 |
| Groups/Cohorts | Assigned Interventions |
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1
Subjects that have received >2 appropriate ICD shock therapies
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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
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2
Subjects that have received >2 inappropriate ICD shock therapies
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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
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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. | |||||
| University of Pittsburgh |
| 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 |
| First Received: | January 27, 2006 |
| Last Updated: | June 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00284453 |
| Health Authority: | United States: Institutional Review Board |
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