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

NCT00284453 | Completed

• 1 other identifier: 0510087
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 2

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.

Conditions

Arrhythmias

Keywords

ventricular; arrhythmias; ICD; VT storm; ICD patients with VT storm

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

1

Forty(40)subjects that have received \>2 appropriate ICD shock therapies

Procedure: Peripheral blood sampling

2

Twenty(20)subjects that have received 1-2(low level)appropriate ICD therapies

Procedure: Peripheral blood sampling

3

Ten(10)subjects that received inappropriate therapies from their ICD

Procedure: Peripheral blood sampling

Interventions

Peripheral blood sampling PROCEDURE

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).

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Inability to give informed consent

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (2)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15216, United States

Location

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.

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandeep K. Jain, M.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor, UPMC Heart and Vascular Institute, Cardiac Electrophysiology

Study Record Dates

• First Submitted: January 27, 2006
• First Posted: January 31, 2006
• Study Start: August 26, 2008
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 12, 2019

Record last verified: 2019-02

Locations

US (2)