Clinical trial NCT00500708: Diagnostic Investigation of Sudden Cardiac Event Risk
Official title: Identifying Markers That Predict Ventricular Arrhythmia Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmia
Cardiovascular Diseases
Heart Failure
CVD
Keywords: 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
Lead sponsor: CardioDx
Sponsor class: INDUSTRY
First posted: 2007-07-13
Enrollment: 1564
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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 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

Primary outcomes:
measure: Gene discovery
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Heart Institute
state: Alaska
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation
state: California
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute and Foundation
state: Minnesota
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Pittsburgh
country: United States
facility: West Penn Allegheny Health System
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Salt Lake City
country: United States
facility: Intermountain Healthcare
state: Utah
Study officials:
affiliation: CardioDx, Inc.
name: Michael Zapien, MS
role: STUDY_DIRECTOR
References:
citation: 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.