Status:
RECRUITING
Risk Characterization of Non-culprit Vessels in Patients Undergoing Primary PCI for ST-elevation MI in Multivessel Disease
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Collaborating Sponsors:
Boston Scientific Corporation
HeartFlow, Inc.
Conditions:
ST Elevation Myocardial Infarction
Eligibility:
All Genders
18-85 years
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 myocar...
Detailed Description
Approximately 50% of patients presenting with an acute ST-segment elevation myocardial infarction (STEMI) have multivessel coronary artery disease (CAD). Five randomized studies have shown that comple...
Eligibility Criteria
Inclusion
- 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
- 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)
- Angiographic exclusion criteria
- 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.
Key Trial Info
Start Date :
January 20 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT06506448
Start Date
January 20 2025
End Date
January 1 2029
Last Update
September 23 2025
Active Locations (3)
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1
University Hospitals Dorset NHS Foundation Trust
Bournemouth, Dorset, United Kingdom, BH15 2JB
2
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
3
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG