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Diagnostic Investigation of Sudden Cardiac Event Risk (DISCERN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00500708
First Posted: July 13, 2007
Last Update Posted: October 19, 2017
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.
Information provided by (Responsible Party):
CardioDx
  Purpose
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
Arrhythmia Cardiovascular Diseases Heart Failure CVD

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 ]
    Genome Wide Association Study (GWAS)


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)
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.

  Eligibility

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.


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
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 ClinicalTrials.gov identifier (NCT number): 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
DISCERN ( Other Identifier: CardioDx )
First Submitted: July 11, 2007
First Posted: July 13, 2007
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
GES
CVD
CHD
Precision Medicine
Genome-wide association study
Cardiovascular Disease
CAD
GWAS
DISCERN

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases