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| Name | Class |
|---|---|
| Henry Ford Health System | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TruGenome Cardiovascular Disease test | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who receive a new monogenic cardiovascular disease finding | Quantify the proportion of patients who receive a new monogenic cardiovascular disease finding from the TruGenome CVD test | 42 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who receive any monogenic cardiovascular disease, cardiovascular risk allele, or cardiovascular pharmacogenomic findings. | Quantify the proportion of patients who receive monogenic cardiovascular disease, cardiovascular risk allele and/or cardiovascular pharmacogenomic findings. | 42 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who received a CoM (as defined above) compared to a contemporaneous matched (2:1) UC group assessed at patient index date (Return of Results), 3 months (90 days), and 6 months (180 days) thereafter. | Quantify the proportion of patients who received a CoM as defined above compared to a contemporaneous matched (2:1) UC group assessed at patient index date (Return of Results), 3 months (90 days), and 6 months (180 days) thereafter. |
Inclusion Criteria:
Individuals ≥18 years of age
Stable ambulatory patients with a cardiology visit within the past year or scheduled within the next 90 days.
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
Must be able to read, understand, and sign an informed consent
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Number of patients who receive monogenic cardiovascular disease, cardiovascular risk allele, or cardiovascular pharmacogenomic findings leading to a CoM within 3 months (90 days) and 6 months (180 days) after Return of Results (RoR). |
Quantify the proportion of patients who receive monogenic cardiovascular disease, cardiovascular risk allele, or cardiovascular pharmacogenomic findings leading to a CoM within 3 months (90 days) and 6 months (180 days) after Return of Results (RoR). |
| Within 3 months (90 days) and 6 months (180 days) after Return of Results |
| Within 3 months (90 days) and 6 months (180 days) after Return of Results |