Actively Recruiting
Risk Characterization of Non-culprit Vessels in Patients Undergoing Primary PCI for ST-elevation MI in Multivessel Disease
Led by University Hospital Southampton NHS Foundation Trust · Updated on 2025-09-23
320
Participants Needed
3
Research Sites
206 weeks
Total Duration
On this page
Sponsors
U
University Hospital Southampton NHS Foundation Trust
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Risk Characterization of Non-culprit Vessels in Patients Undergoing Primary PCI for ST-elevation MI in Multivessel Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent after PPCI
- Aged 18 to 85 years
- Acute STEMI within 12 hours of symptom onset
- Undergoing PPCI of the culprit artery
- Presence of non-infarct artery narrowing over 50% with minimum diameter of 2.5 mm
You will not qualify if you...
- Cardiogenic shock
- Decompensated heart failure needing intubation, inotropes, or balloon pump
- Refractory ventricular arrhythmia
- Previous coronary artery bypass surgery (CABG)
- Stent thrombosis or in-stent restenosis
- Planned revascularization of non-culprit lesion before study inclusion
- Active cancer or inflammatory disorders like rheumatoid arthritis or inflammatory bowel disease
- Severe valvular heart disease requiring surgery
- Planned surgical revascularization
- Current participation in another study
- Life expectancy less than 12 months
- Contraindications to CT coronary angiography including internal defibrillator, allergy to iodinated contrast, pregnancy, contraindication to beta blockers or sublingual nitrates, mechanical prosthetic heart valve, advanced kidney impairment, or severe valve disease
- Angiographic exclusions: left main stem or ostial stenosis in key arteries, less than TIMI grade 3 blood flow in non-infarct artery, or thrombus in non-infarct artery
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University Hospitals Dorset NHS Foundation Trust
Bournemouth, Dorset, United Kingdom, BH15 2JB
Actively Recruiting
2
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
Actively Recruiting
3
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
Actively Recruiting
Research Team
Z
Zoe Nicholas
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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