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Genetic Test
Whole Genome Sequencing for Cardiovascular Disease
N/A
Recruiting
Research Sponsored by Illumina, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 months
Awards & highlights
Study Summary
This trial will assess the accuracy of a new test & how it may help people with heart disease by changing how they're managed.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves a diagnostic test rather than a medication or therapy intervention, there are no direct side effects from the test itself. However, any medical procedures required as part of the testing process may carry typical procedural risks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 42 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients who receive a new monogenic cardiovascular disease finding
Secondary outcome measures
Number of patients who receive any monogenic cardiovascular disease, cardiovascular risk allele, or cardiovascular pharmacogenomic findings.
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).
Other outcome measures
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.
Trial Design
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 Location
Who is running the clinical trial?
Henry Ford Health SystemOTHER
300 Previous Clinical Trials
2,098,499 Total Patients Enrolled
Illumina, Inc.Lead Sponsor
24 Previous Clinical Trials
152,896 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am 18 years old or older.I have a heart or blood vessel condition.I am able to understand and give consent for my treatment.I can walk and have seen or will see a heart doctor within a year.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment capacity for this clinical trial?
"Affirmative, clinicaltrials.gov records show that this study is presently recruiting patients. It was initially published on December 23rd 2022 and last updated January 6th 2023. This research seeks a total of 1500 participants from 1 location."
Answered by AI
Is this study currently seeking participants?
"Affirmative. According to clinicaltrials.gov, this medical trial is currently in the process of recruiting participants after being first posted on December 23rd 2022 and last updated on January 6th 2023. 1500 prospective patients must be recruited from a single site."
Answered by AI
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