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Genetic Testing

Genetic testing arm for High Cholesterol

N/A
Waitlist Available
Led By Deepak Voora, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Are a Veteran
* Aged 40-75 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15-months
Awards & highlights

Summary

Statins are the most cost-effective medications to lower cholesterol and cardiovascular disease (CVD) risk. However, many patients at high-risk for CVD do not accept or adhere to statins. This gap in patient's use of statins limits the full impact of these effective medications resulting in higher cholesterol levels and CVD risk. The main barriers to using statins are patients' perceived lack of benefit, excess risk of statin toxicity as well as their misperceptions of their CVD risk. Statin pharmacogenomic testing - an application of precision medicine - is a readily available, feasible, and inexpensive intervention that addresses this barrier by using genetic testing to identify the nearly 1 out of 2 patients with enhanced benefit and/or reduced risk of statin toxicity or increased risk for CVD. By communicating statin pharmacogenomic test results to Veterans at high-risk for CVD not taking statin therapy, the investigators aim to improve patients' perceptions of their risk of CVD and statins and, in turn, their acceptance of and adherence to statins to reduce their cholesterol levels and CVD risk.

Who is the study for?
This trial is for individuals with high cholesterol who are at risk for cardiovascular disease (CVD) but may be hesitant to take statins due to concerns about their effectiveness or potential side effects. Participants should not currently be on statin therapy.
What is being tested?
The study tests whether genetic testing can help predict the benefits and risks of taking statins, potentially improving patient acceptance and adherence by personalizing treatment plans based on individual genetic profiles.
What are the potential side effects?
While specific side effects are not detailed here, common ones associated with statins include muscle pain, digestive problems, increased blood sugar levels, and neurological symptoms like memory loss or confusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in low density lipoprotein cholesterol

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Genetic testing armExperimental Treatment1 Intervention
The intervention involves: genetic testing; interpretation; and prior to and shortly following an upcoming appointment, communication to patients and providers about the patients' predicted statin efficacy and toxicity, genetic risk for CVD, and individualized recommended statin type/dose.
Group II: ControlActive Control1 Intervention
The control condition involves receipt of a report highlighting the risk of cardiovascular disease and benefits of statins (without genetic test results).

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,638 Previous Clinical Trials
3,327,153 Total Patients Enrolled
Deepak Voora, MDPrincipal InvestigatorDurham VA Medical Center, Durham, NC
3 Previous Clinical Trials
365 Total Patients Enrolled
~273 spots leftby May 2027