NCT07848529Not yet recruiting
Clinical Evidence With Biomarker Confirmation for PPMI in PCI Clinical Trials Study
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 26 Aug 2026
- Start date
- Dec 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Baim Institute for Clinical Research
- Diseases
- Heart failure, Coronary artery disease
- NCT number
- NCT07848529
What you commit to
- Study type: Observational
- Planned participants: 1000
- From Dec 2026 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous percutaneous coronary intervention within 7 days.
Other illness
- ST elevation myocardial infarction within 7 days
- Non-ST elevation myocardial infarction without stable or declining biomarkers.
- Decompensated heart failure.
Lab values
- Inability to comply with recommended duration of dual anti-platelet therapy.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baim Institute for Clinical Research Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.