NCT06506448Recruiting
Risk Characterization of Non-culprit Vessels in Patients Undergoing Primary PCI for ST-elevation MI in Multivessel Disease
Anatomical, Physiological and Inflammatory Characterization of the Non-Culprit Vessels in Patients Undergoing Primary PCI for ST-Elevation Myocardial Infarction in the Presence of Multivessel Disease Toward a Personalised Approach to Complete Revascularisation After Primary PCI
Source: ClinicalTrials.gov · Last updated 23 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 320 (estimated)
- First submitted
- 22 May 2024
- Start date
- 20 Jan 2025
- Primary completion date
- Mar 2026
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Diseases
- Coronary artery disease
- NCT number
- NCT06506448
What you commit to
- Study type: Observational
- Planned participants: 320
- From 20 Jan 2025 to the primary completion date, Mar 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous coronary artery bypass surgery (CABG)
- Planned surgical revascularisation
Other illness
- Decompensated heart failure requiring intubation, inotropes, or intra-aortic balloon counter pulsation
- Refractory ventricular arrhythmia
- Stent thrombosis and in stent restenosis
- Active malignancy or inflammatory disorders such as rheumatoid arthritis or inflammatory bowel disease
- Severe valvular heart disease requiring surgery
- \< TIMI (thrombolysis in myocardial infarction) flow grade 3 in the NIRA,
Lab values
- 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
Other
- Cardiogenic shock
- An intention before inclusion into the study to revascularize a non-culprit lesion
- Active participation in another study/trial
- \< 12 months life expectancy
- NIRA stenosis of 50% or more in the left main stem or the ostia of both the left anterior descending and circumflex arteries
- Evidence of thrombus in the NIRA.
Who the study is looking for
- Ability to provide written informed consent (post PPCI)
- Age 18 years to 85 years
- Presentation of acute STEMI within 12 hours of symptom on-set
- Culprit artery PPCI
- Coronary stenosis of \> 50% diameter stenosis by visual estimation in NIRA with a minimum diameter of 2.5mm
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Dorset NHS Foundation Trust Coordinator of this site? Confirm its status | Bournemouth | United Kingdom | Recruiting |
| University Hospital Southampton NHS Foundation Trust Coordinator of this site? Confirm its status | Southampton | United Kingdom | Recruiting |
| Royal Stoke University Hospital Coordinator of this site? Confirm its status | Stoke-on-Trent | United Kingdom | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.