An observational study in Peri-procedural Myocardial Infarction, Heart Failure Hospitalization and Mortality, sponsored by Baim Institute for Clinical Research. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Baim Institute for Clinical Research · Observational
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:
Participants will:
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 relationship with subsequent adverse outcomes remain uncertain.
Several definitions of PPMI are currently used, including the Fourth Universal Definition of Myocardial Infarction, the Academic Research Consortium-2 (ARC-2) definition, and the Society for Cardiovascular Angiography and Interventions (SCAI) definition. These definitions differ in their required biomarker thresholds and in how clinical evidence of periprocedural ischemia is incorporated. In addition, routine collection of serial post-PCI biomarkers can be challenging in contemporary practice, particularly because many patients are discharged on the same day as their procedure. Differences among cardiac biomarkers, including troponin I, troponin T, and creatine kinase-myocardial band (CK-MB), may also affect the frequency with which PPMI is diagnosed.
CEC-PPMI is a prospective, multicenter, non-randomized cohort study designed to evaluate the relationship among clinical evidence of periprocedural ischemia, cardiac biomarker elevation after PCI, and adverse clinical outcomes at one year. The study will enroll up to 1,000 adults at up to 20 clinical sites in the United States. An adaptive enrollment design will be used to ensure that at least 250 participants have positive clinical criteria.
Eligible participants will have stable coronary artery disease, including stable angina or functional evidence of ischemia, or stabilized non-ST-elevation acute coronary syndrome, and will be undergoing PCI. The PCI procedure will be performed according to local standards of care using commercially approved devices or devices being evaluated under an applicable investigational device exemption. The study does not assign a specific PCI device, treatment strategy, or medical therapy. The study will not analyze outcomes according to a specific device or manufacturer.
Before PCI, participants will provide informed consent. Baseline demographic information, clinical characteristics, and procedural and lesion-related information will also be collected.
All participants will have cardiac biomarker samples collected before PCI and approximately 4 to 6 hours after PCI. Participants who remain hospitalized will have an additional sample collected approximately 12 to 24 hours after PCI. All samples will be sent to and analyzed at a central laboratory for CK-MB, troponin T, and troponin I. Centralized analysis will allow direct comparison of these biomarkers using samples collected at the same time, with each participant serving as a matched control.
After PCI, the study team will complete a clinical criteria checklist. The checklist will identify clinical evidence potentially consistent with periprocedural myocardial ischemia, including relevant symptoms, electrocardiographic findings, and angiographic complications. The study team will also document whether the participant is planned for same-day discharge or hospitalization for at least one night.
Baseline lesion characteristics and PCI-related angiographic findings will be evaluated by an independent angiographic core laboratory. Assessments will include lesion length, bifurcation involvement, thrombus, percentage diameter stenosis, dissection, side-branch occlusion, distal embolization, and slow coronary flow. Agreement between clinical-site reporting and independent core-laboratory assessment of angiographic complications will be examined.
Participants will be categorized according to the result of the clinical criteria checklist and their planned post-PCI disposition. The four prespecified groups are:
The key secondary endpoint is the composite of all-cause mortality or hospitalization for heart failure at one year. This outcome will be compared between participants with positive and negative clinical criteria. The individual components of the composite endpoint will also be evaluated.
Additional analyses will examine:
Follow-up at one year to assess vital status and whether hospitalization for heart failure has occurred will be completed using a direct-to-participant remote approach. If contact with the participant is unsuccessful, an alternate contact will be approached. If this is also unsuccessful, a series of additional follow-up methods, as permitted by the participant's consent and applicable requirements, will be used to ascertain the secondary endpoint.
The study is intended to clarify whether a standardized, clinically driven assessment can help identify patients at increased risk for meaningful cardiac biomarker elevation after PCI and whether combining clinical criteria with specific biomarker thresholds improves the identification of patients at risk for adverse outcomes. The findings may also inform future definitions of PPMI and reduce the burden and missing data associated with routine serial biomarker collection in PCI clinical trials.
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.
Exclusion Criteria:
Patients with a positive checklist and same day discharge
Diagnostic Test: Biomarker testing
Patients with a negative checklist and hospitalization
Diagnostic Test: Biomarker testing
Patients with a negative clinical checklist and same day discharge
Diagnostic Test: Biomarker testing
Patients with a positive clinical checklist and hospitalization
Diagnostic Test: Biomarker testing
CKMB, 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.
Time frame: Peri-procedural, up to 24 hours
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.
Time frame: 1 year
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.
Time frame: Peri-procedural, up to 24 hours.
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
Time frame: 1 year
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
Time frame: Up to 24 hours
Plan to share: Undecided
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Baim Institute for Clinical Research