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

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT00284453

Collaborator

(none)

Enrollment

Locations

123.2

Actual Duration (Months)

32.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

65 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Gene Expression in ICD Patients With Electrical Storm

Actual Study Start Date :

Aug 26, 2008

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	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).

Arm

Intervention/Treatment

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).

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).

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).

Outcome Measures

Primary Outcome Measures

Genetic Testing [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)
Genetic Testing [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;