NCT05332262Recruiting
A Precision Medicine Approach to Identify Patients Undergoing Elective PCI at Risk of Peri-PCI Myocardial Infarction
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
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
Despite the relative safety of PCI with new generation stents, peri-PCI thrombotic complications, including myocardial infarction and myocardial injury, are common in elective PCI, occurring in up to 30% of patients. Importantly, these events are associated with poor prognosis. The risk of peri-PCI myocardial infarction/myocardial injury has been in part attributed to HPR. The aim of this study is to prospectively validate the accuracy of the ABCD-GENE score in identifying stable CAD patients undergoing elective PCI treated with standard of care clopidogrel who are at risk of peri-PCI myocardial infarction/myocardial injury. This investigation will be a prospective cohort study conducted in a population of patients (n=500) with stable CAD undergoing elective PCI treated with standard of care clopidogrel. By integrating genetic data with clinical variables, patients will be stratified into 2 cohorts based on their ABCD-GENE score (using a cut-off of 10). Assessments to define HPR status and myocardial infarction/myocardial injury will be performed post-PCI.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 11 Apr 2022
- Start date
- 23 May 2022
- Primary completion date
- Dec 2026
- Lead sponsor
- University of Florida
- Diseases
- Coronary artery disease
- NCT number
- NCT05332262
What you commit to
- Study type: Observational
- Planned participants: 500
- From 23 May 2022 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- On treatment with prasugrel or ticagrelor;
- Use of an intravenous antiplatelet therapy (i.e., cangrelor or GPI) during PCI;
Other illness
- Current presentation with myocardial infarction;
- Documented hypersensitivity to clopidogrel;
Other
- Unable to provide written informed consent.
Who the study is looking for
- Stable CAD undergoing elective PCI;
- Male or females, Age ≥ 18 years old;
- Troponin negative before PCI\*;
- Background of aspirin therapy;
- If troponin is unknown before coronary angiography and no clinical signs of acute coronary syndrome is present, a troponin will not be collected as this is line with standard practice.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Florida - Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.