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
University Hospital Southampton NHS Foundation Trust
320 participants
Jan 20, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria5
- 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
Exclusion Criteria23
- Cardiogenic shock
- Decompensated heart failure requiring intubation, inotropes, or intra-aortic balloon counter pulsation
- Refractory ventricular arrhythmia
- Previous coronary artery bypass surgery (CABG)
- Stent thrombosis and in stent restenosis
- An intention before inclusion into the study to revascularize a non-culprit lesion
- Active malignancy or inflammatory disorders such as rheumatoid arthritis or inflammatory bowel disease
- Severe valvular heart disease requiring surgery
- Planned surgical revascularisation
- Active participation in another study/trial
- \< 12 months life expectancy
- 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)
- NIRA stenosis of 50% or more in the left main stem or the ostia of both the left anterior descending and circumflex arteries
- \< TIMI (thrombolysis in myocardial infarction) flow grade 3 in the NIRA,
- Evidence of thrombus in the NIRA.
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Interventions
CTCA for anatomical, physiological, plaque composition and inflammatory assessment of coronary arteries
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06506448