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(904) 244-0411

The ABCD-Gene Prospective Study

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
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Description

This investigation will be a prospective cohort study conducted in a population of 500 patients 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. Data will be collected and then entered into a secure database.

Details

Protocol number IRB202200298

Eligibility

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;

* Troponin negative will be defined as hs-cTn below the URL for the laboratory (Male < 22 ng/L; Female < 14 ng/L) or modestly positive hs-cTn (Male: 22-99 ng/L; Female: 14-99 ng/L) flat or decreasing from hour 0 to 3.

† 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.

Lead researcher

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.