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Ventricular Tachyarrhythmia (VT) Storm, Gene Expression in Implantable Cardioverter Defibrillator (ICD) Patients With Electrical Storm
This study is currently recruiting participants.
Verified by University of Pittsburgh, June 2008
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
Arrhythmias
Procedure: Peripheral blood sampling

Genetics Home Reference related topics: Brugada syndrome short QT syndrome
MedlinePlus related topics: Arrhythmia
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Gene Expression in ICD Patients With Electrical Storm

Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

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
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

Detailed Description:

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
Study Population

Thirty men and women over age 18 with electrical strom that we hope will volunteer to participate in this genetic research study

Criteria

Inclusion Criteria:

  • ICD patients at least 18 years of age presenting with greater than 2 therapies for ventricular arrhythmias within a 72-hour period
  • Able to give informed consent

Exclusion Criteria:

  • Inability to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00284453

Contacts
Contact: Sandeep K. Jain, M.D. 412-647-6272 jainsk@upmc.edu
Contact: Pamela M. White, BSN 412-647-2931 whitepm@upmc.edu

Locations
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.            
Sponsors and Collaborators
University of Pittsburgh
Investigators
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: June 16, 2008
ClinicalTrials.gov Identifier: NCT00284453  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
ventricular
arrhythmias
ICD
VT storm
ICD patients with VT storm

Study placed in the following topic categories:
Heart Diseases
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009