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Diagnostic Investigation of Sudden Cardiac Event Risk (DISCERN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00500708
Recruitment Status : Completed
First Posted : July 13, 2007
Last Update Posted : October 19, 2017
Information provided by (Responsible Party):

Brief Summary:
The overall objective of the DISCERN study is to develop and validate a genomic diagnostic assay to identify patients at increased risk for lethal ventricular arrhythmias and sudden cardiac death (SCD).

Condition or disease
Arrhythmia Cardiovascular Diseases Heart Failure CVD

Detailed Description:

This is a prospective, multi-center, observational study. The research will be performed in three phases, each using distinct patient cohorts:

Phase I: Discovery - genes/biomarkers/clinical factors Phase II: Algorithm Development Phase III: Assay Validation

The final algorithm (Assay) may incorporate a combination of factors including genetic markers, biomarker(s), and clinical factor(s). Participation in the study does not alter clinical care. The procedures required by the protocol are collection of a research blood sample (at baseline only) and interviews with the subject to collect specific clinical information at baseline and follow-up (6 mos, 1 yr, 2 yr, 3 yr, 4 yr, and 5 yr) after enrollment. All other data collected is in accordance with the participating institution's standard patient care.

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Study Type : Observational
Actual Enrollment : 1564 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identifying Markers That Predict Ventricular Arrhythmia Risk
Study Start Date : July 2007
Actual Primary Completion Date : August 1, 2011
Actual Study Completion Date : August 1, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Primary Outcome Measures :
  1. Gene discovery [ Time Frame: up to 3 years ]
    Genome Wide Association Study (GWAS)

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00500708

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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
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Study Director: Michael Zapien, MS CardioDx, Inc.
Publications of Results:
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.

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Responsible Party: CardioDx Identifier: NCT00500708    
Other Study ID Numbers: CDX_000003
DISCERN ( Other Identifier: CardioDx )
First Posted: July 13, 2007    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Keywords provided by CardioDx:
Heart failure
Implanted Cardioverter Defibrillator
Biological Markers
Molecular Genetics
Coronary Heart Disease
Gene Expression
Precision Medicine
Genome-wide association study
Cardiovascular Disease
Additional relevant MeSH terms:
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Heart Failure
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes