Diagnostic Investigation of Sudden Cardiac Event Risk

CardioDx1,564 enrolled

Overview

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).

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 Type

OBSERVATIONAL

Enrollment

1,564

Conditions

Arrhythmia Cardiovascular Diseases Heart Failure CVD

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Gene discovery

Genome Wide Association Study (GWAS)

Time frame: up to 3 years

Data from ClinicalTrials.gov

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