Baim Institute for Clinical Research
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.
Periprocedural myocardial infarction (PPMI) is commonly included as an outcome in clinical trials involving percutaneous coronary intervention (PCI). However, uncertainty remains regarding the most appropriate cardiac biomarker, biomarker threshold, and accompanying clinical criteria to use when defining PPMI. The increasing use of high-sensitivity troponin assays has further complicated the interpretation of cardiac biomarker elevations after PCI. Lower biomarker thresholds may identify a relatively large proportion of patients, but the clinical significance of these elevations and their rela…
Inclusion Criteria: 1. Subject age is ≥ 18 years or minimum legal age as required by local regulations. 2. Documented stable angina or functional testing demonstrating ischemia; or stabilized non-ST elevation acute coronary syndrome defined as negative or confirmed declining site determined biomarker. 3. Subject is eligible for dual anti-platelet therapy treatment with aspirin plus either, clopidogrel, prasugrel, or ticagrelor. 4. Life expectancy \>1 year in opinion of investigator. 5. Subject is willing and able to provide informed consent and comply with study procedures and required follow…
CKMB, Troponin T and Troponin I levels