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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Baim Institute for Clinical Research
Study ID
NCT07848529
Status
Not Yet Recruiting

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Conditions

  • Heart Failure Hospitalization
  • Mortality
  • Non ST Elevation Myocardial Infarction (NSTEMI)
  • Peri-procedural Myocardial Infarction
  • Stable Angina Pectoris

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biomarker testing — DIAGNOSTIC_TEST
    CKMB, Troponin T and Troponin I levels

Study Details

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.

Key Dates

First listed
Sep 30, 2026
Start date
Dec 31, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Same day discharge with positive clinical checklist
    Patients with a positive checklist and same day discharge
  • Arm: Hospitalization with negative clinical checklist
    Patients with a negative checklist and hospitalization
  • Arm: Same day discharge with negative clinical checklist
    Patients with a negative clinical checklist and same day discharge
  • Arm: Hospitalization with positive clinical checklist
    Patients with a positive clinical checklist and hospitalization

Primary Outcome Measure

The rate of elevation of troponin I or T > 5 times the upper reference limit (URL) [ Time Frame: Peri-procedural, up to 24 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
Baim Institute for Clinical ResearchBostonMassachusetts02215
Donald E Cutlip, MD
[email protected]
Cecilia Bahit, MD
[email protected]
Donald E Cutlip, MD (PRINCIPAL_INVESTIGATOR)
Cecilia Bahit, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Baim Institute for Clinical Research· Boston, MA

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