RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-05-23
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05332262

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Stable CAD undergoing elective PCI;
  2. 2. Male or females, Age ≥ 18 years old;
  3. 3. Troponin negative before PCI\*;
  4. 4. Background of aspirin therapy;
  5. * 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.
  1. 1. Current presentation with myocardial infarction;
  2. 2. On treatment with prasugrel or ticagrelor;
  3. 3. Documented hypersensitivity to clopidogrel;
  4. 4. Use of an intravenous antiplatelet therapy (i.e., cangrelor or GPI) during PCI;
  5. 5. Unable to provide written informed consent.

Contacts and Locations

Study Contact

Francesco Franchi, MD
CONTACT
9042442060
francesco.franchi@jax.ufl.edu
Andrea Burton
CONTACT
9042445617
Andrea.Burton@jax.ufl.edu

Principal Investigator

Francesco Franchi, MD
PRINCIPAL_INVESTIGATOR
University of Florida College of Medicine Jacksonville

Study Locations (Sites)

University of Florida Jacksonville
Jacksonville, Florida, 32209
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Francesco Franchi, MD, PRINCIPAL_INVESTIGATOR, University of Florida College of Medicine Jacksonville

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-23
Study Completion Date2025-08

Study Record Updates

Study Start Date2022-05-23
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Coronary Artery Disease