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NOT YET RECRUITING
NCT07848529

Clinical Evidence With Biomarker Confirmation for PPMI in PCI Clinical Trials Study

Sponsor: Baim Institute for Clinical Research

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

Biomarker testing

CKMB, Troponin T and Troponin I levels

Locations (1)

Baim Institute for Clinical Research

Boston, Massachusetts, United States