Diagnostic Investigation of Sudden Cardiac Event Risk

Identifying Markers That Predict Ventricular Arrhythmia Risk

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00500708

Acronym

DISCERN

Enrollment

1564

Registered

2007-07-13

Start date

2007-07-31

Completion date

2011-08-01

Last updated

2017-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia, Cardiovascular Diseases, CVD, Heart Failure

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Gene discovery	up to 3 years	Genome Wide Association Study (GWAS)

Countries

United States

Outcome results