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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
University of Florida
Study ID
NCT05332262
Status
Recruiting
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Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
May 23, 2022
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: 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).
  • Arm: 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).

Primary Outcome Measure

Peri-PCI myocardial infarction or myocardial injury [ Time Frame: 24 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Florida JacksonvilleJacksonvilleFlorida32209
Francesco Franchi, MD

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By research site
University of Florida Jacksonville· Jacksonville, FL

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