NCT06506448 Risk Characterization of Non-culprit Vessels in Patients Undergoing Primary PCI for ST-elevation MI in Multivessel Disease
| NCT ID | NCT06506448 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Southampton NHS Foundation Trust |
| Condition | ST Elevation Myocardial Infarction |
| Study Type | OBSERVATIONAL |
| Enrollment | 320 participants |
| Start Date | 2025-01-20 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 320 participants in total. It began in 2025-01-20 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Ability to provide written informed consent (post PPCI) 2. Age 18 years to 85 years 3. Presentation of acute STEMI within 12 hours of symptom on-set 4. Culprit artery PPCI 5. Coronary stenosis of \> 50% diameter stenosis by visual estimation in NIRA with a minimum diameter of 2.5mm Exclusion Criteria: 1. Cardiogenic shock 2. Decompensated heart failure requiring intubation, inotropes, or intra-aortic balloon counter pulsation 3. Refractory ventricular arrhythmia 4. Previous coronary artery bypass surgery (CABG) 5. Stent thrombosis and in stent restenosis 6. An intention before inclusion into the study to revascularize a non-culprit lesion 7. Active malignancy or inflammatory disorders such as rheumatoid arthritis or inflammatory bowel disease 8. Severe valvular heart disease requiring surgery 9. Planned surgical revascularisation 10. Active participation in another study/trial 11. \< 12 months life expectancy 12. Contraindication to CTCA * Presence of internal defibrillator * Known allergy to iodinated contrast * Pregnancy * Contraindication to intravenous beta blockade * Contraindication to acute sublingual nitrate administration * Mechanical prosthetic heart valve * Advanced renal impairment (creatinine \>200) * Significant valve disease (sever aortic stenosis or regurgitation; severe mitral regurgitation) Angiographic exclusion criteria 1. NIRA stenosis of 50% or more in the left main stem or the ostia of both the left anterior descending and circumflex arteries 2. \< TIMI (thrombolysis in myocardial infarction) flow grade 3 in the NIRA, 3. Evidence of thrombus in the NIRA.
Contact & Investigator
Nick Curzen, PhD
PRINCIPAL INVESTIGATOR
University Hospital Southampton NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT06506448 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying ST Elevation Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06506448 currently recruiting?
Yes, NCT06506448 is actively recruiting participants. Contact the research team at zoe.nicholas@uhs.nhs.uk for enrollment information.
Where is the NCT06506448 trial being conducted?
This trial is being conducted at Bournemouth, United Kingdom, Southampton, United Kingdom, Stoke-on-Trent, United Kingdom.
Who is sponsoring the NCT06506448 clinical trial?
NCT06506448 is sponsored by University Hospital Southampton NHS Foundation Trust. The principal investigator is Nick Curzen, PhD at University Hospital Southampton NHS Foundation Trust. The trial plans to enroll 320 participants.