Whole Genome Sequencing for Cardiovascular Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is whole genome sequencing for cardiovascular disease safe for humans?
Whole genome sequencing (WGS) and next-generation sequencing (NGS) technologies have been widely used in clinical settings for cardiovascular diseases without specific safety concerns reported. These technologies are primarily used for genetic testing and diagnosis, which are generally considered safe as they involve analyzing DNA from a blood sample or saliva.12345
How does the TruGenome Cardiovascular Disease test treatment differ from other treatments for cardiovascular disease?
The TruGenome Cardiovascular Disease test is unique because it uses whole genome sequencing (WGS) to identify genetic variants that may increase the risk of cardiovascular disease, allowing for personalized prevention and management strategies. Unlike traditional treatments that focus on symptoms, this test aims to uncover genetic predispositions, offering a more tailored approach to patient care.13456
What data supports the effectiveness of the TruGenome Cardiovascular Disease test treatment?
The research highlights that next-generation sequencing (NGS) technology, which is used in the TruGenome Cardiovascular Disease test, has been successful in identifying genetic mutations linked to cardiovascular diseases. This can help in diagnosing conditions and developing personalized treatment plans, potentially improving patient outcomes.14578
Are You a Good Fit for This Trial?
This trial is for adults over 18 with cardiovascular disease, including coronary or peripheral arterial disease, arrhythmias, dyslipidemia, heart failure or cardiomyopathy. They must have seen a cardiologist recently or have an appointment soon. It's not for those with known genetic heart diseases, severe cognitive issues, cancer treatment ongoing, very short life expectancy, bone marrow transplant recipients or end-stage renal disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo Whole Genome Sequencing (WGS) to assess diagnostic efficacy and impact on clinical management
Return of Results
Participants receive results from the WGS and any changes in management are assessed
Follow-up
Participants are monitored for changes in management and outcomes at 3 and 6 months after Return of Results
What Are the Treatments Tested in This Trial?
Interventions
- TruGenome Cardiovascular Disease test
Find a Clinic Near You
Who Is Running the Clinical Trial?
Illumina, Inc.
Lead Sponsor
Henry Ford Health System
Collaborator