Diagnostic Investigation of Sudden Cardiac Event Risk
DISCERN
Identifying Markers That Predict Ventricular Arrhythmia Risk
2 other identifiers
observational
1,564
1 country
8
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2007
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 11, 2007
CompletedFirst Posted
Study publicly available on registry
July 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedOctober 19, 2017
October 1, 2017
4.1 years
July 11, 2007
October 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gene discovery
Genome Wide Association Study (GWAS)
up to 3 years
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Congenital heart disease
- Known inherited arrhythmia disorder
- Organ transplantation
- Inability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CardioDxlead
Study Sites (8)
Alaska Heart Institute
Anchorage, Alaska, 99508, United States
Palo Alto Medical Foundation
Palo Alto, California, 94301, United States
Minneapolis Heart Institute and Foundation
Minneapolis, Minnesota, 55407, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
West Penn Allegheny Health System
Pittsburgh, Pennsylvania, 15212, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Intermountain Healthcare
Salt Lake City, Utah, 84111, United States
Related Publications (1)
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.
RESULT
Biospecimen
whole blood, buffy coat, spun plasma, saliva
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Zapien, MS
CardioDx, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2007
First Posted
July 13, 2007
Study Start
July 1, 2007
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
October 19, 2017
Record last verified: 2017-10