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Diagnostic Investigation of Sudden Cardiac Event Risk (DISCERN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CardioDx
ClinicalTrials.gov Identifier:
NCT00500708
First received: July 11, 2007
Last updated: February 15, 2017
Last verified: February 2017
  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
Official Title: Identifying Markers That Predict Ventricular Arrhythmia Risk

Further study details as provided by CardioDx:

Primary Outcome Measures:
  • Gene discovery [ Time Frame: up to 3 years ]
    whole genome association study (WGAS)


Biospecimen Retention:   Samples With DNA
whole blood, buffy coat, spun plasma, saliva

Enrollment: 1564
Study Start Date: July 2007
Study Completion Date: August 1, 2011
Primary Completion Date: August 1, 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  • Implantable cardiac defibrilIator (ICD) or cardiac resynchronization therapy defibrillator (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Director: Michael Zapien, MS CardioDx, Inc.
  More Information

Publications:
Hranitzky PM, Sehnert AJ, Blanchard JL, et al. Abstract 16410: Identification of novel genetic markers associated with lethal ventricular arrhythmias in heart failure patients: genome wide association study in the DISCERN cohort. Circulation. 2010;122. Abstract 16410.

Responsible Party: CardioDx
ClinicalTrials.gov Identifier: NCT00500708     History of Changes
Other Study ID Numbers: CDx_000003
Study First Received: July 11, 2007
Last Updated: February 15, 2017

Keywords provided by CardioDx:
Heart failure
Implanted Cardioverter Defibrillator
Biological Markers
Molecular Genetics

ClinicalTrials.gov processed this record on April 21, 2017