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NCT05332262 · ClinicalTrials.gov registry record
A Precision Medicine Approach to Identify Patients Undergoing Elective PCI at Risk of Peri-PCI Myocardial Infarction
A clinical trial of Coronary Artery Disease, sponsored by University of Florida.
- Recruiting
- Registry status
- 500
- Enrollment target
- 1
- Study location
NCT05332262: Recruiting study of Coronary Artery Disease, sponsored by University of Florida.
NCT05332262 is a study of Coronary Artery Disease that is actively recruiting participants, run by University of Florida. The registered enrollment target is 500 participants, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05332262, a study of Coronary Artery Disease, is actively recruiting participants, sponsored by University of Florida.
- RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The primary endpoint of the study will be rate of peri-PCI myocardial infarction or myocardial injury, which will be compared between the high ABCD-GENE score cohort and the low ABCD-GENE score cohort.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Assessment of platelet reactivity
- DIAGNOSTIC_TEST Troponin measurement
Study Locations (1)
Florida
- University of Florida Jacksonville - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2022-05-23 |
| Est. Completion | 2027-08 |
What NCT05332262 shows while recruiting
NCT05332262 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Assessment of platelet reactivity is the first listed.
NCT05332262 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05332262 about?
NCT05332262 is a clinical study titled "A Precision Medicine Approach to Identify Patients Undergoing Elective PCI at Risk of Peri-PCI Myocardial Infarction". 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 ...
What is the current status of trial NCT05332262?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2022-05-23. Estimated completion is 2027-08.
What conditions does trial NCT05332262 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT05332262?
The interventions under investigation include: Assessment of platelet reactivity (DIAGNOSTIC_TEST), Troponin measurement (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05332262?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05332262 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05332262's enrollment target sits among peer trials
500 74th of 219 higher than 145 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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