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Clinical Evidence With Biomarker Confirmation for PPMI in PCI Clinical Trials Study
Sponsor: Baim Institute for Clinical Research
Summary
The goal of this prospective, multicenter, non-randomized observational study is to better identify and understand periprocedural myocardial injury among adults undergoing percutaneous coronary intervention (PCI) for stable coronary artery disease or stabilized non-ST-elevation acute coronary syndrome. The main questions it aims to answer are: * Can a clinical criteria checklist identify patients with an increased likelihood of cardiac biomarker elevation following PCI? * Are positive clinical criteria and different post-PCI levels of troponin I, troponin T, and CK-MB associated with all-cause mortality or hospitalization for heart failure at one year? Researchers will compare participants with a positive clinical criteria checklist with those with a negative checklist to assess differences in post-PCI biomarker elevations and one-year clinical outcomes. Outcomes will also be compared between participants discharged on the same day and those hospitalized overnight. Participants will: * Undergo PCI using commercially approved devices according to local standards of care. * Have blood samples collected before and after PCI to measure cardiac biomarkers. * Have relevant clinical and PCI procedural information collected, including completion of a clinical criteria checklist by the study team before discharge. * Be followed for one year to determine whether they have died from any cause or been hospitalized for heart failure.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2026-12
Completion Date
2029-12
Last Updated
2026-09-30
Healthy Volunteers
No
Conditions
Interventions
Biomarker testing
CKMB, Troponin T and Troponin I levels
Locations (1)
Baim Institute for Clinical Research
Boston, Massachusetts, United States