Actively Recruiting
Ability of a Precision Medicine Approach to Identify Stable CAD Patients Undergoing Elective PCI Who Are at Risk of Peri-PCI Myocardial Infarction/Myocardial Injury: The ABCD-Gene Prospective Study
Led by University of Florida · Updated on 2026-01-20
500
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the ability of the ABCD-GENE score, a precision medicine tool combining clinical and genetic factors, to identify stable coronary artery disease (CAD) patients undergoing elective percutaneous coronary intervention (PCI) who are at risk of peri-PCI myocardial infarction or myocardial injury. These complications occur in up to 30% of patients despite newer stents and are linked to worse outcomes. The study aims to prospectively validate this score in patients treated with standard clopidogrel therapy. This study is a prospective cohort involving about 500 stable CAD patients receiving elective PCI and standard care clopidogrel. Participants are divided into two groups based on their ABCD-GENE score, which includes age, body mass index, chronic kidney disease, diabetes, and a genetic marker (CYP2C19 loss of function). Platelet reactivity and high platelet reactivity status are assessed after PCI using the VerifyNow P2Y12 test. Additionally, high sensitivity troponin levels are measured post-PCI to detect myocardial infarction or injury. Participants will undergo blood tests after PCI to measure platelet reactivity and troponin levels to determine myocardial infarction or injury within 24 hours. The study closely monitors these outcomes to validate the predictive accuracy of the ABCD-GENE score. The research may help tailor antiplatelet treatment strategies for patients at increased risk. The trial is expected to continue through August 2027.
CONDITIONS
Brief Title
A Precision Medicine Approach to Identify Patients Undergoing Elective PCI at Risk of Peri-PCI Myocardial Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Stable coronary artery disease undergoing elective PCI
- Male or female aged 18 years or older
- Negative troponin test before PCI (unless clinical signs of acute coronary syndrome are absent and troponin is unknown)
- Currently on aspirin therapy
You will not qualify if you...
- Current presentation with myocardial infarction
- Treatment with prasugrel or ticagrelor
- Documented allergy or hypersensitivity to clopidogrel
- Use of intravenous antiplatelet therapy (such as cangrelor or GPI) during PCI
- Unable to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 hours post-PCI
Participants with stable coronary artery disease undergoing elective PCI are observed to assess platelet reactivity and myocardial injury risk using the ABCD-GENE score.
1 visit post-PCI (in-person)
Trial Site Locations
Total: 1 location
1
University of Florida Jacksonville
Jacksonville, Florida, United States, 32209
Actively Recruiting
Research Team
F
Francesco Franchi, MD
A
Andrea Burton
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here