Blood tests for heart injury after stent procedures in coronary artery disease
Checks blood markers of heart injury in adults getting stents for coronary artery disease.
Key facts
- Who runs it
- Baim Institute for Clinical Research
- Where
- Boston, United StatesSee the site
- Trial code
- Registry title
- Clinical Evidence With Biomarker Confirmation for PPMI in PCI Clinical Trials Study
- Status
- Not yet recruiting
- People taking part
- 1,000 people, planned
- Starts
- Dec 2026
- Expected to end
- Dec 2029
- Type of study
- Observational, 4 groups
- Treatments tested
- Biomarker testing
- Record updated
- 30 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults having a stenting procedure (PCI) for stable coronary artery disease or a stabilised heart attack of the non-ST-elevation type. Blood heart markers are measured before and after, and people are followed for one year.
- Age
- 18 years or older, or the minimum legal age set by local rules.
- Sex
- All sexes can join.
- Disease stage
- Stable angina or a test showing reduced blood supply to the heart, or stabilised non-ST-elevation acute coronary syndrome with a negative or falling blood marker.
- Earlier treatment
- Must be able to take aspirin plus clopidogrel, prasugrel or ticagrelor. No earlier PCI within 7 days.
- Biomarker or test result
- Troponin I, troponin T and CK-MB blood levels are measured before and after PCI. For stabilised acute coronary syndrome, the site's heart marker must be negative or falling.
Main reasons for not taking part
- ST-elevation heart attack within 7 days
- Non-ST-elevation heart attack without stable or falling heart markers
- PCI within the last 7 days
- Cannot keep to the advised length of dual antiplatelet therapy
- Decompensated heart failure
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
- Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations
Who cannot take part
- Previous percutaneous coronary intervention within 7 days
- ST elevation myocardial infarction within 7 days
- Non-ST elevation myocardial infarction without stable or declining biomarkers
- Decompensated heart failure
- Inability to comply with recommended duration of dual anti-platelet therapy
Where in United States
- Baim Institute for Clinical ResearchBoston, United StatesContact: Donald E Cutlip, MDNot yet recruiting
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
* 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.
The 4 groups in the trial
- Same day discharge with positive clinical checklist
Patients with a positive checklist and same day discharge
Treatment: Biomarker testing
- Hospitalization with negative clinical checklist
Patients with a negative checklist and hospitalization
Treatment: Biomarker testing
- Same day discharge with negative clinical checklist
Patients with a negative clinical checklist and same day discharge
Treatment: Biomarker testing
- Hospitalization with positive clinical checklist
Patients with a positive clinical checklist and hospitalization
Treatment: Biomarker testing
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Clinical Evidence With Biomarker Confirmation for PPMI in PCI Clinical Trials Study
- Plain-language title
- Blood tests for heart injury after stent procedures in coronary artery diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 30 September 2026