Diagnostic Investigation of Sudden Cardiac Event Risk - Full Text View

Diagnostic Investigation of Sudden Cardiac Event Risk (DISCERN)

This study has been suspended.

( Lack of patients with appropriate therapy )

First Received on July 11, 2007. Last Updated on October 17, 2011 History of Changes

Sponsor:	CardioDx
Information provided by (Responsible Party):	CardioDx
ClinicalTrials.gov Identifier:	NCT00500708

Purpose

Heart failure (HF) affects 5 million Americans, with 500,000 new cases diagnosed and 250,000 deaths each year. The two major causes of morbidity and mortality in HF are pump failure and sudden, lethal ventricular arrhythmias, the latter of which accounts for 40-50% of HF deaths. Arrhythmias may be precipitated by a complex interaction of genetic and environmental factors. Establishing increased risk for arrhythmias before a severe life-threatening event is critically important. However, this remains a significant medical challenge.

Several genetic mutations associated with rare, inherited arrhythmia disorders have been identified. The aim of this study is to identify novel genetic and other biological markers that distinguish patients at increased risk for lethal ventricular arrhythmias in a broader population.

Condition
Arrhythmia

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome Help Me Understand Genetics

MedlinePlus related topics: Arrhythmia Heart Failure

U.S. FDA Resources

Further study details as provided by CardioDx:

Biospecimen Retention: Samples With DNA

whole blood, buffy coat, spun plasma, saliva

Estimated Enrollment:	3000
Study Start Date:	July 2007

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patient's with ventricular dysfunction (low ejection fraction) undergoing implantation of ICD or CRT-D for primary prevention. Patient's may be enrolled at time of implant or during follow-up in electrophysiology clinic as long as full device records are available since time of implant.

Criteria

Inclusion Criteria:

ICD or CRT-D implanted for primary prevention
Left ventricular ejection fraction (LVEF) ≤ 50 %
Ability to collect clinical follow-up and endpoint information, including device interrogation data

Exclusion Criteria:

Congenital heart disease
Known inherited arrhythmia disorder
Organ transplantation
Inability to give informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500708

Locations

United States, Alaska
Alaska Heart Institute
Anchorage, Alaska, United States, 99508
United States, California
Palo Alto Medical Foundation
Palo Alto, California, United States, 94301
United States, Minnesota
Minneapolis Heart Institute and Foundation
Minneapolis, Minnesota, United States, 55407
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
West Penn Allegheny Health System
Pittsburgh, Pennsylvania, United States, 15212
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Utah
Intermountain Healthcare
Salt Lake City, Utah, United States, 84111

Sponsors and Collaborators

CardioDx

More Information

No publications provided

Responsible Party:	CardioDx
ClinicalTrials.gov Identifier:	NCT00500708 History of Changes
Other Study ID Numbers:	CDx_000003
Study First Received:	July 11, 2007
Last Updated:	October 17, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by CardioDx:

Heart failure
Implanted Cardioverter Defibrillator
Biological Markers
Molecular Genetics

Additional relevant MeSH terms:

Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012