DISCERN: Diagnostic Investigation of Sudden Cardiac Event Risk

Sponsor

CardioDx (Industry)

Overall Status

Completed

CT.gov ID

NCT00500708

Collaborator

(none)

1,564

Enrollment

Locations

Duration (Months)

195.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

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 :

Jul 1, 2007

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Outcome Measures

Primary Outcome Measures

Gene discovery [up to 3 years]
Genome Wide Association Study (GWAS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Alaska Heart Institute	Anchorage	Alaska	United States	99508
2	Palo Alto Medical Foundation	Palo Alto	California	United States	94301
3	Minneapolis Heart Institute and Foundation	Minneapolis	Minnesota	United States	55407
4	Duke University Medical Center	Durham	North Carolina	United States	27705
5	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
6	West Penn Allegheny Health System	Pittsburgh	Pennsylvania	United States	15212
7	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
8	Intermountain Healthcare	Salt Lake City	Utah	United States	84111