Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1500 participants
INTERVENTIONAL
2023-01-06
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Single Arm
To investigate the diagnostic efficacy of WGS 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Stable ambulatory patients with a cardiology visit within the past year or scheduled within the next 90 days.
3. At least one of the following clinical diagnoses:
A. Any aortopathy, B. Dyslipidemia, C. Coronary or peripheral arterial disease, D. Heart Failure or cardiomyopathy, E. Any arrythmia
4. Must be able to read, understand, and sign an informed consent
Exclusion Criteria
2. Bone marrow transplant recipients
3. Individuals with severe cognitive dysfunction or diminished capacity who are unable to provide informed consent
4. Patients undergoing active chemotherapy treatment for cancer
5. Patients with end-stage renal disease
6. Patients with poor medical prognosis with a life expectancy \<1 year
7. Principal Investigator decides for any reason the study is not in the best interest of the patient
18 Years
ALL
No
Sponsors
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Henry Ford Health System
OTHER
Illumina, Inc.
INDUSTRY
Responsible Party
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Locations
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Henry Ford Health System
Detroit, Michigan, United States
Countries
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Other Identifiers
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ILMN-007
Identifier Type: -
Identifier Source: org_study_id
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