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RECRUITING
NCT05332262

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

Sponsor: University of Florida

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2022-05-23

Completion Date

2027-08

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Assessment of platelet reactivity

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.

DIAGNOSTIC_TEST

Troponin measurement

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

Locations (1)

University of Florida Jacksonville

Jacksonville, Florida, United States