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

Arrhythmias Clinical Trial

Official title:

Gene Expression in ICD Patients With Electrical Storm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00284453
• Other study ID #: 0510087
• Status: Completed
• Start date: August 26, 2008
• Est. completion date: December 2018

Study information

• Verified date: February 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias

Intervention

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).

Locations

Country	Name	City	State
United States	UPMC Presbyterian Hospital	Pittsburgh	Pennsylvania
United States	UPMC Shadyside Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic Testing	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)	Day 1 Enrollment
Primary	Genetic Testing	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)	Day 90 +/- 30 days