Overview

This trial is active, not recruiting.

Condition arrhythmias
Treatment peripheral blood sampling
Sponsor University of Pittsburgh
Start date October 2005
End date December 2016
Trial size 75 participants
Trial identifier NCT00284453, 0510087

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Forty(40)subjects that have received >2 appropriate ICD shock therapies
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).
Twenty(20)subjects that have received 1-2(low level)appropriate ICD therapies
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).
Ten(10)subjects that received inappropriate therapies from their ICD
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 Outcomes

Measure
Genetic Testing
time frame: Day 1 Enrollment
Genetic Testing
time frame: Day 90 +/- 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Gene Expression in ICD Patients With Electrical Storm
Principal investigator Sandeep K. Jain, M.D.
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).
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Pittsburgh.