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ACTIVE NOT RECRUITING
NCT05656183
NA

CardioSeq: Impact of WGS in Individuals With CVD

Sponsor: Illumina, Inc.

View on ClinicalTrials.gov

Summary

This is a prospective, single-center, open-label study to investigate the diagnostic efficacy of the TruGenome CVD test and its impact on clinical management compared to usual care in individuals with cardiovascular disease. Diagnostic yield and changes of management (CoM) will be assessed both within the WGS group and compared to a contemporaneous, matched (2:1) usual care (UC) group sourced from EHR records.

Official title: CardioSeq: A Prospective, Single-Center, Open-label Study to Evaluate the Impact of Whole Genome Sequencing (WGS) in Individuals With Cardiovascular Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1500

Start Date

2023-01-06

Completion Date

2025-06

Last Updated

2024-04-30

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

TruGenome Cardiovascular Disease test

The TruGenome Cardiovascular Disease (CVD) test which consists of an in-silico 200 gene cardiovascular disease panel, a further 4 genes with cardiovascular disease risk alleles, 10 pharmacogenomic genes, 35 non-cardiovascular ACMG secondary finding genes and a polygenic risk score (PRS) for coronary artery disease (CAD) will be utilized in this study.

Locations (1)

Henry Ford Health System

Detroit, Michigan, United States