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Risk Characterization of Non-culprit Vessels in Patients Undergoing Primary PCI for ST-elevation MI in Multivessel Disease

NCT06506448 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 320

Last updated 2025-09-23

No results posted yet for this study

Summary

Most heart attacks occur because a clot forms in a coronary artery blocking blood flow. Without blood heart muscle dies. Untreated, clots can cause a specific type of heart attack -ST-elevation myocardial infarction (STEMI). STEMI patients are treated immediately by finding the blocked artery ("culprit" lesion) using a dye injected into the coronary arteries and then by unblocking the artery using balloons and stents. This procedure - primary angioplasty - is offered 24/7 and limits the size of heart attacks and saves lives.

Cardiologists know how to treat STEMI patients but it's less clear what to do about narrowings in other coronary arteries ("bystander" disease). This is important - if they're left alone some bystander lesions can cause future events including heart attacks or angina. Recent trials compared stenting ALL the bystander narrowings after primary angioplasty, with stenting none and showed some benefit from stenting all of them ("complete revascularisation").

However, complete revascularisation carries extra risk, putting patients through more complicated procedures and using up resource. A blanket strategy of complete revascularisation of ALL bystander narrowings in ALL STEMI patients is unlikely to be the correct answer as only a small minority of these patients have further events.

In PICNIC the investigators want to identify bystander narrowings most likely to cause a future event, and those unlikely to do so. The study can then test the hypothesis that only the high-risk bystander narrowings need stenting, and the others can be treated with tablets only. Investigators will study patients using specialised imaging techniques from coronary artery CT scans and levels of inflammation to see which narrowings cause future events and which do not. If this can be done, a case can be made to test complete revascularisation only in bystander narrowings that look high risk.

Conditions

  • ST Elevation Myocardial Infarction

Interventions

DIAGNOSTIC_TEST

CT Coronary Angiography

CTCA for anatomical, physiological, plaque composition and inflammatory assessment of coronary arteries

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • HeartFlow, Inc.

    collaborator INDUSTRY

  • Wessex Heartbeat

    collaborator UNKNOWN

  • Caristo

    collaborator UNKNOWN

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Nick Curzen, PhD · University Hospital Southampton NHS Foundation Trust

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-20
Primary Completion
2026-03-31
Completion
2029-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06506448 on ClinicalTrials.gov