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

NCT07848529 | Not Yet Recruiting

• 1 other identifier: CEC PPMI
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

PCI; Coronary artery disease; biomarkers

Outcome Measures

Primary Outcomes (1)

• 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.

  Peri-procedural, up to 24 hours

Secondary Outcomes (1)

• All-cause mortality at 1 year

  1 year

Other Outcomes (3)

• Biomarker Analyses

  Peri-procedural, up to 24 hours.

• One-Year Clinical Outcome Analyses

  1 year

• Frequency of PPMI

  Up to 24 hours

Study Arms (4)

Same day discharge with positive clinical checklist

Patients with a positive checklist and same day discharge

Diagnostic Test: Biomarker testing

Hospitalization with negative clinical checklist

Patients with a negative checklist and hospitalization

Diagnostic Test: Biomarker testing

Same day discharge with negative clinical checklist

Patients with a negative clinical checklist and same day discharge

Diagnostic Test: Biomarker testing

Hospitalization with positive clinical checklist

Patients with a positive clinical checklist and hospitalization

Diagnostic Test: Biomarker testing

Interventions

Biomarker testing DIAGNOSTIC_TEST

CKMB, Troponin T and Troponin I levels

Hospitalization with negative clinical checklist; Hospitalization with positive clinical checklist; Same day discharge with negative clinical checklist; Same day discharge with positive clinical checklist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• ST elevation myocardial infarction within 7 days
• Non-ST elevation myocardial infarction without stable or declining biomarkers.
• Previous percutaneous coronary intervention within 7 days.
• Inability to comply with recommended duration of dual anti-platelet therapy.
• Decompensated heart failure.

Sponsors & Collaborators

• Baim Institute for Clinical Research: lead

Study Sites (1)

Baim Institute for Clinical Research

Boston, Massachusetts, 02215, United States

Location

Related Publications (25)

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Related Links

• Baim Institute for Clinical Research Website

MeSH Terms

Conditions

Angina, Stable; Non-ST Elevated Myocardial Infarction; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 30, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 30, 2026

Record last verified: 2026-08

Locations

US (1)