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.
Subject age is ≥ 18 years or minimum legal age as required by local regulations.
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.
Subject is eligible for dual anti-platelet therapy treatment with aspirin plus either, clopidogrel, prasugrel, or ticagrelor.
Life expectancy >1 year in opinion of investigator.
ST elevation myocardial infarction within 7 days
Non-ST elevation myocardial infarction without stable or declining biomarkers.
Previous percutaneous coronary intervention within 7 days.
Inability to comply with recommended duration of dual anti-platelet therapy.
Based on the results of the clinical criteria checklist and clinical team decision regarding same day discharge or planned hospitalization, there will be 4 study groups identified: Negative checklist/Same day discharge; Negative checklist/Hospitalization; Positive checklist/Same day discharge; Positive checklist/Hospitalization.
Cohort
Prospective
Biomarker testing
Diagnostic testCKMB, Troponin T and Troponin I levels
The rate of elevation of troponin I or T > 5 times the upper reference limit (URL)
The primary endpoint is the rate of elevation of troponin I or T \> 5 times the upper reference limit (URL). The primary comparison will be for the group with positive clinical criteria checklist versus the group with negative clinical criteria checklist based on central laboratory assessment.
All-cause mortality at 1 year
All-cause mortality at 1 year. The primary comparison will be for the group with positive clinical criteria checklist versus the group with negative clinical criteria checklist.
Biomarker Analyses
* Distribution of CK-MB, troponin T and troponin I normalized as a ratio to the URL of each assay (mean ± SD, median, interquartile range). * Proportion of subjects with troponin T or I elevation \> 5 times the URL in patients without hospitalization (same day discharge) compared with patients planned for hospitalization. Assess impact of second sample at 12-24 hours. * Frequency of troponin T versus troponin I elevations (\<3 times URL; 3-5 times URL; \>5-10 times URL; \>10-35 times URL; \>35-70 times URL; \>70 times URL) overall and stratified by positive clinical criteria.
One-Year Clinical Outcome Analyses
* Composite of all-cause mortality and heart failure hospitalization for positive clinical criteria versus negative clinical criteria. Unadjusted and adjusted for clinical and baseline lesion characteristics. * Mortality or heart failure hospitalization composite and components at 1 year for planned hospitalization versus same day discharge. * One year mortality or heart failure hospitalization composite and components by biomarker threshold (\<3 times URL; 3-5 times URL; \>5-10 times URL; \>10-35 times URL; \>35-70 times URL; \>70 times URL) Troponin T, Troponin I, CKMB
Frequency of PPMI
Frequency of PPMI according to various definitions. * 4th Universal (+ clinical criteria only) Troponin I or T, Troponin T, Troponin I * ARC II (\>35 x URL for troponin with + clinical criteria or \>5x ULN for CKMB with + clinical criteria) Troponin I or T, Troponin T, Troponin I, CKMB * SCAI Troponin I or T \>70 times URL, Troponin T \>70 times URL, Troponin I \>70 times URL, CKMB \>10 times URL
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
