Diagnostic Investigation of Sudden Cardiac Event Risk

Completed

• Conditions: Heart Failure; Cardiovascular Diseases; Arrhythmia; CVD

• Registration Number: NCT00500708
• Lead Sponsor: CardioDx

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-11
• Study First Submitted QC: 2007-07-11
• Study First Posted: 2007-07-13
• Primary Completion: 2011-08-01
• Study Completion: 2011-08-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-17
• Last Update Posted: 2017-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1564

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gene discovery	up to 3 years	Genome Wide Association Study (GWAS)

Trial Locations

Locations (8)

Alaska Heart Institute; 🇺🇸 Anchorage, Alaska, United States

Palo Alto Medical Foundation; 🇺🇸 Palo Alto, California, United States

Minneapolis Heart Institute and Foundation; 🇺🇸 Minneapolis, Minnesota, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

West Penn Allegheny Health System; 🇺🇸 Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Intermountain Healthcare; 🇺🇸 Salt Lake City, Utah, United States