A Precision Medicine Approach to Identify Patients Undergoing Elective PCI at Risk of Peri-PCI Myocardial Infarction

NCT05332262 | Recruiting DMC

• 1 other identifier: IRB202200298
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

percutaneous coronary intervention; clopidogrel; high platelet reactivity; myocardial injury

Outcome Measures

Primary Outcomes (1)

• Peri-PCI myocardial infarction or myocardial injury

  The primary endpoint of the study will be rate of peri-PCI myocardial infarction or myocardial injury, which will be compared between the high ABCD-GENE score cohort and the low ABCD-GENE score cohort.

  24 hours

Study Arms (2)

High ABCD-GENE score (≥10)

All patients in this cohort will have an ABCD-GENE score ≥10 and will be receiving clopidogrel following PCI as per standard of care. The ABCD-GENE score encompasses a total of 5 variables: 4 clinical (age, body mass index, chronic kidney disease status, and diabetes mellitus) and 1 genetic (CYP2C19 LOF).

Diagnostic Test: Assessment of platelet reactivity; Diagnostic Test: Troponin measurement

Low ABCD-GENE score (<10)

All patients in this cohort will have an ABCD-GENE score \<10 and will be receiving clopidogrel following PCI as per standard of care. The ABCD-GENE score encompasses a total of 5 variables: 4 clinical (age, body mass index, chronic kidney disease status, and diabetes mellitus) and 1 genetic (CYP2C19 LOF).

Diagnostic Test: Assessment of platelet reactivity; Diagnostic Test: Troponin measurement

Interventions

Assessment of platelet reactivity DIAGNOSTIC_TEST

Assessment of platelet reactivity and HPR status will be performed post-PCI. Platelet reactivity will be measured by VerifyNow P2Y12 and HPR status will be defined using a cut-off value of platelet reactivity units (PRU)\>208.

High ABCD-GENE score (≥10); Low ABCD-GENE score (<10)

Troponin measurement DIAGNOSTIC_TEST

Measurement of high sensitivity troponin for the assessment for the presence of myocardial infarction/myocardial injury will be performed post-PCI.

High ABCD-GENE score (≥10); Low ABCD-GENE score (<10)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All-comers population of troponin-negative CAD patients undergoing elective PCI as part of their standard of care at the Division of Cardiology of University of Florida Health, Jacksonville, Florida. Genotyping will be performed as per standard of care in the UF Health Pathology lab.

You may qualify if:

• 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.

You may not qualify if:

• Current presentation with myocardial infarction;
• On treatment with prasugrel or ticagrelor;
• Documented hypersensitivity to clopidogrel;
• Use of an intravenous antiplatelet therapy (i.e., cangrelor or GPI) during PCI;
• Unable to provide written informed consent.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Jacksonville

Jacksonville, Florida, 32209, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be stored for future analysis, which may include assessment of markers of inflammation, novel genetic variants, or micro-RNA. Blood samples will be stored in a UF-approved storage bank (IRB202100157).

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Francesco Franchi, MD

  University of Florida College of Medicine Jacksonville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Franchi, MD

CONTACT

9042442060; francesco.franchi@jax.ufl.edu

Andrea Burton

CONTACT

9042445617; Andrea.Burton@jax.ufl.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 18, 2022
• Study Start: May 23, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)