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

NCT ID: NCT00284453

Last Updated: 2019-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-26

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Arrhythmias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

Peripheral blood sampling

Intervention Type 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).

2

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

Peripheral blood sampling

Intervention Type 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).

3

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

Peripheral blood sampling

Intervention Type 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).

Interventions

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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).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Sandeep Jain

MD, Assistant Professor, UPMC Heart and Vascular Institute, Cardiac Electrophysiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandeep K. Jain, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

Site Status

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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0510087

Identifier Type: -

Identifier Source: org_study_id

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