Status:
COMPLETED
Synergy Between morpHOlogical and inflammatoRy Evaluation in Predicting Long-term Coronary Plaque Progression
Lead Sponsor:
University of Bologna
Collaborating Sponsors:
University of Cambridge
Centro per la Lotta Contro l'Infarto - Fondazione Onlus
Conditions:
Acute Coronary Syndrome
Atherosclerosis
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Data from human autopsy studies have showed that thrombosis of a ruptured plaque with a large necrotic core, inflammatory cells and a thin fibrous cap, the so-called thin cap fibroatheroma (TCFA), rep...
Detailed Description
ACS are the leading cause of mortality and morbidity in the western world. Despite recommended therapies, after experiencing an ACS episode patients still have an increased cardiovascular risk during ...
Eligibility Criteria
Inclusion
- Male or female participants \> 50 years old
- Able to give written, informed consent and to lie flat
- Presentation of ACS within \~2 weeks
- At least 1 intermediate (30-80% diameter stenosis) non-culprit coronary artery lesion on angiography, managed medically as clinically indicated (i.e.: negative FFR/iFR)
Exclusion
- Women of child bearing potential not using adequate contraception
- Contrast allergy or contrast-nephropathy
- Uncontrolled atrial fibrillation
- Chronic kidney disease (eGFR \<30 l/min/1.73m2)
- Uncontrolled chronic inflammatory disorder
- History of recent malignancy deemed relevant to the study by the investigator
- Current use of systemic corticosteroids
- Previous coronary artery bypass grafting surgery (CABG) or percutaneous coronary intervention (PCI) before the index event
- Contraindication to coronary angiography
- Requires CABG or staged non-culprit artery PCI
- Coronary vessels that could not be adequately imaged
- Severe valvular heart disease
- Any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study.
Key Trial Info
Start Date :
June 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05436977
Start Date
June 21 2021
End Date
June 21 2024
Last Update
May 20 2025
Active Locations (1)
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1
University of Bologna IRCCS Policlinico di St. Orsola
Bologna, Italy