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

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ClinicalTrials.gov Identifier: NCT00284453
Recruitment Status : Active, not recruiting
First Posted : January 31, 2006
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Sandeep Jain, University of Pittsburgh

Brief Summary:
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 or disease Intervention/treatment
Arrhythmias Procedure: Peripheral blood sampling

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).

Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gene Expression in ICD Patients With Electrical Storm
Study Start Date : October 2005
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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).



Primary Outcome Measures :
  1. Genetic Testing [ Time Frame: Day 1 Enrollment ]
    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)

  2. Genetic Testing [ Time Frame: Day 90 +/- 30 days ]
    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.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284453


Locations
United States, Pennsylvania
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15216
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Sandeep K. Jain, M.D. University of Pittsburgh

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
First Posted: January 31, 2006    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017

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