Diagnostic Investigation of Sudden Cardiac Event Risk - Full Text View

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

Genetics Home Reference related topics:

Brugada syndrome short QT syndrome

MedlinePlus related topics:

Arrhythmia Heart Failure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Further study details as provided by CardioDx:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

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

Contacts


Contact: Amy J Sehnert, MD	650-475-2705	asehnert@cardiodx.com

Locations


United States, Alaska
	Alaska Heart Institute	Recruiting
	Anchorage, Alaska, United States, 99508
	Principal Investigator: Steve Compton, MD

United States, California
	Palo Alto Medical Foundation	Recruiting
	Palo Alto, California, United States, 94301
	Principal Investigator: Sun Chung, MD

United States, Minnesota
	Minneapolis Heart Institute and Foundation	Recruiting
	Minneapolis, Minnesota, United States, 55407
	Principal Investigator: William Katsiyiannis, MD

United States, North Carolina
	Duke University Medical Center	Recruiting
	Durham, North Carolina, United States, 27705
	Principal Investigator: Patrick Hranitzky, MD

United States, Ohio
	Cleveland Clinic Foundation	Not yet recruiting
	Cleveland, Ohio, United States, 44195
	Principal Investigator: Steven Ellis, MD
	Sub-Investigator: Oussama Wazni, MD

United States, Pennsylvania
	West Penn Allegheny Health System	Recruiting
	Pittsburgh, Pennsylvania, United States, 15212
	Principal Investigator: Christopher Bonnet, MD

United States, Tennessee
	Vanderbilt University Medical Center	Recruiting
	Nashville, Tennessee, United States, 37232
	Principal Investigator: Dawood Darbar, MD

United States, Utah
	Intermountain Healthcare	Recruiting
	Salt Lake City, Utah, United States, 84111
	Principal Investigator: John Day, MD

Sponsors and Collaborators

CardioDx

Investigators


Study Director:	Amy J Sehnert, MD	CardioDx, Inc.

More Information

Responsible Party:	CardioDx, Inc. ( Amy Sehnert, MD; Director, Clinical R&D )
Study ID Numbers:	CDx_000003
First Received:	July 11, 2007
Last Updated:	December 28, 2007
ClinicalTrials.gov Identifier:	NCT00500708
Health Authority:	United States: Institutional Review Board

Keywords provided by CardioDx:

Heart failure

Implanted Cardioverter Defibrillator

Biological Markers

Molecular Genetics

Study placed in the following topic categories:

Heart Failure

Heart Diseases

Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 04, 2008

Sponsored by:	CardioDx
Information provided by:	CardioDx
ClinicalTrials.gov Identifier:	NCT00500708