1500 Participants Needed

Whole Genome Sequencing for Cardiovascular Disease

KR
Overseen ByKeisha Robinson
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Illumina, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

I have a heart or blood vessel condition.
Must be able to read, understand, and sign an informed consent
I can walk and have seen or will see a heart doctor within a year.

Exclusion Criteria

I have a genetic condition linked to heart disease.
I am currently receiving chemotherapy for my cancer.
My kidneys are in the final stage of failure.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Whole Genome Sequencing (WGS) to assess diagnostic efficacy and impact on clinical management

42 months

Return of Results

Participants receive results from the WGS and any changes in management are assessed

Immediate

Follow-up

Participants are monitored for changes in management and outcomes at 3 and 6 months after Return of Results

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • TruGenome Cardiovascular Disease test
Trial Overview The study tests the TruGenome Cardiovascular Disease test to see if it's better at diagnosing and influencing treatment decisions in cardiovascular patients compared to standard care. Participants will be matched against others receiving usual care based on their electronic health records.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Illumina, Inc.

Lead Sponsor

Trials
25
Recruited
154,000+

Henry Ford Health System

Collaborator

Trials
334
Recruited
2,197,000+

Published Research Related to This Trial

The understanding of how genetic variations influence cardiovascular disease has significantly advanced in the past 15 years, highlighting the potential for precision medicine in improving patient care.
Despite the promise of genomics in managing cardiovascular diseases, challenges remain in implementing genomics-guided approaches due to the complexity of common diseases and a lack of familiarity among clinicians with genomic medicine.
Precision Cardiovascular Medicine: State of Genetic Testing.Giudicessi, JR., Kullo, IJ., Ackerman, MJ.[2022]
In a review of 147 clinical trials for cardiovascular disease (CVD), only 1 trial (less than 1%) used a genomic biomarker prospectively to enhance patient selection, despite 32% of drug targets having relevant genetic evidence.
Almost half (46%) of the trials indicated exploratory use of biomarkers, suggesting a significant opportunity to improve drug development efficiency by better integrating genetic knowledge into clinical trial designs.
An Overview of Genomic Biomarker Use in Cardiovascular Disease Clinical Trials.Adeniyi, O., Ramamoorthy, A., Schuck, R., et al.[2021]

Citations

Precision Cardiovascular Medicine: State of Genetic Testing. [2022]
Implementing genome-driven personalized cardiology in clinical practice. [2023]
Next generation sequencing applications for cardiovascular disease. [2022]
Validation and Utilization of a Clinical Next-Generation Sequencing Panel for Selected Cardiovascular Disorders. [2022]
Integrative analysis of loss-of-function variants in clinical and genomic data reveals novel genes associated with cardiovascular traits. [2020]
An Overview of Genomic Biomarker Use in Cardiovascular Disease Clinical Trials. [2021]
7.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Screening for Rare Genetic Variants Associated with Atherosclerosis: Opportunity for Personalized Medicine. [2020]
Genetic cardiomyopathies. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security