NCT00500708

Diagnostic Investigation of Sudden Cardiac Event Risk

Identifying Markers That Predict Ventricular Arrhythmia Risk

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,564 (actual)
• Sponsor: CardioDx · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arrhythmia
• Cardiovascular Diseases
• Heart Failure
• CVD

Timeline

• Start date: 2007-07-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2007-07-13
• Last updated: 2017-10-19

Locations

8 sites across 1 country: United States