Ventricular Tachyarrhythmia (VT) Storm, Gene Expression in Implantable Cardioverter Defibrillator (ICD) Patients With Electrical Storm

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Sandeep Jain, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00284453
First received: January 27, 2006
Last updated: May 21, 2014
Last verified: May 2014
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gene Expression in ICD Patients With Electrical Storm

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Genetic Testing [ Time Frame: Day 1 Enrollment ] [ Designated as safety issue: No ]
    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)

  • Genetic Testing [ Time Frame: Day 90 +/- 30 days ] [ Designated as safety issue: No ]
    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)


Biospecimen Retention:   Samples With DNA

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.


Estimated Enrollment: 75
Study Start Date: October 2005
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Forty(40)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, 1-2(low level) or inappropriate therapies, device data and repeat bloodwork in 3 months(+/- 4weeks).
2
Twenty(20)subjects that have received 1-2(low level)appropriate ICD therapies
Procedure: Peripheral blood sampling
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).
3
Ten(10)subjects that received inappropriate therapies from their ICD
Procedure: Peripheral blood sampling
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).

Detailed Description:

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).

  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 that present within a 72 hour period: 1) > 2 therapies for ventricular arrhythmias; 2) 1-2 therapies for ventricular arrhythmias; 3) inappropriate therapies for ventricular arrhythmias
  • Able to give informed consent

Exclusion Criteria:

  • Inability to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Kimberly A Veltre, MSN 412-864-1420 veltrek@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

No publications provided

Responsible Party: Sandeep Jain, MD, Assistant Professor, UPMC Heart and Vascular Institute, Cardiac Electrophysiology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00284453     History of Changes
Other Study ID Numbers: 0510087
Study First Received: January 27, 2006
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Tachycardia, Ventricular
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014