Ignite Creation Date:
2024-05-06 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05332262
Status:
RECRUITING
Last Update Posted:
2024-01-19
First Post:
2022-04-11
Brief Title:
A Precision Medicine Approach to Identify Patients Undergoing Elective PCI at Risk of Peri-PCI Myocardial Infarction
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Ability of a Precision Medicine Approach to Identify Stable CAD Patients Undergoing Elective PCI Who Are at Risk of Peri-PCI Myocardial InfarctionMyocardial Injury The ABCD-Gene Prospective Study
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 infarctionmyocardial 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 infarctionmyocardial injury This investigation will be a prospective cohort study conducted in a population of patients n500 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 infarctionmyocardial injury will be performed post-PCI
Detailed Description:
Antiplatelet therapy with aspirin and a P2Y12 inhibitor is the cornerstone of treatment for patients undergoing percutaneous coronary intervention PCI Clopidogrel is the recommended P2Y12 inhibitor in patients with stable coronary artery disease CAD undergoing elective PCI However clopidogrel effects are subject to variability and 30-40 of patients have high platelet reactivity HPR which translates into higher rates of thrombotic complications 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 infarctionmyocardial injury has been in part attributed to HPR The investigators recently developed a precision medicine tool integrating clinical and genetic factors called ABCD-GENE able to identify HPR status This score helps characterize patients at risk for peri-PCI thrombotic complications who can thus potentially benefit from changes in antiplatelet treatment regimen However the ABCD-GENE score was generated through retrospective assessments thus warranting prospective validation The high frequency of elective PCI procedures and the prevalence with which myocardial infarctionmyocardial injury occurs underscore the need for tools that can better identify patients at risk so that therapeutic measures can be implemented to improve their prognosis 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 infarctionmyocardial injury This investigation will be a prospective cohort study conducted in a population of patients n500 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 infarctionmyocardial injury will be performed post-PCI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None