Identifying patients at risk of heart attack during elective PCI
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
This study is testing a new scoring system to see if it can help identify patients with stable heart disease who are at risk of having a heart attack during a specific heart procedure called PCI.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT05332262 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the ABCD-GENE score, a precision medicine tool that integrates genetic and clinical data, to identify patients with stable coronary artery disease (CAD) who are at risk of experiencing myocardial infarction or myocardial injury during elective percutaneous coronary intervention (PCI). The study will involve a prospective cohort of 500 patients undergoing elective PCI while being treated with clopidogrel. By assessing platelet reactivity and troponin levels, the researchers hope to stratify patients based on their risk and potentially improve treatment outcomes. The findings could lead to better management strategies for patients undergoing PCI.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with stable coronary artery disease undergoing elective PCI who are negative for troponin before the procedure.
Not a fit: Patients currently experiencing a myocardial infarction or those on alternative antiplatelet therapies like prasugrel or ticagrelor will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at high risk for complications during PCI, allowing for tailored antiplatelet therapy and improved patient outcomes.
How similar studies have performed: Other studies have shown promise in using genetic and clinical factors to predict thrombotic complications in PCI, but this specific approach with the ABCD-GENE score is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Stable CAD undergoing elective PCI; 2. Male or females, Age ≥ 18 years old; 3. Troponin negative before PCI\*; 4. 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. Exclusion criteria: 1. Current presentation with myocardial infarction; 2. On treatment with prasugrel or ticagrelor; 3. Documented hypersensitivity to clopidogrel; 4. Use of an intravenous antiplatelet therapy (i.e., cangrelor or GPI) during PCI; 5. Unable to provide written informed consent.
Where this trial is running
Jacksonville, Florida
- University of Florida Jacksonville — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Francesco Franchi, MD — University of Florida College of Medicine Jacksonville
- Study coordinator: Francesco Franchi, MD
- Email: francesco.franchi@jax.ufl.edu
- Phone: 9042442060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.