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Clinical Evidence With Biomarker Confirmation for PPMI in PCI Clinical Trials Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at heart muscle injury around the time of PCI, a procedure to open narrowed heart arteries. It is for adults with stable heart artery disease or a recent heart problem that has become stable. Researchers will check whether a checklist and blood tests can help identify injury and are linked to death or a hospital stay for heart failure within one year.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old, or meet the minimum legal age where you live.
  • Have stable chest pain from heart artery disease, a test showing low blood flow to the heart, or a recent heart problem without a certain ECG change that is now stable, with blood markers of heart injury absent or falling.
  • Be able to take aspirin plus clopidogrel, prasugrel, or ticagrelor. These medicines help prevent blood clots.
  • Be expected by the study doctor to live more than one year.
  • Be willing and able to agree to join and complete study steps and follow-up visits.

Who can't join

  • Had a heart attack with a certain ECG change, called STEMI, within the past 7 days.
  • Have a heart attack without that ECG change, called NSTEMI, with blood markers of heart injury that are not stable or falling.
  • Had PCI to open heart arteries within the past 7 days.
  • Cannot take both blood clot prevention medicines for the recommended time.
  • Have heart failure that is worsening or not under control.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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-up evaluations. Exclusion Criteria: 1. ST elevation myocardial infarction within 7 days 2. Non-ST elevation myocardial infarction without stable or declining biomarkers. 3. Previous percutaneous coronary intervention within 7 days. 4. Inability to comply with recommended duration of dual anti-platelet therapy. 5. Decompensated heart failure.

Study sites (1)

MA