Synergy Between morpHOlogical and inflammatoRy Evaluation in Predicting Long-term Coronary Plaque Progression
NCT05436977 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-05-20
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), represents the main mechanism for acute coronary syndrome (ACS). Optical coherence tomography (OCT) is an imaging technique that provides high-resolution, cross-sectional images of tissue in situ. The resolution of OCT (10 um) is appropriate for measuring a cap thickness less than65 μm, and even the plaque macrophage density. 68Ga-DOTA-(Tyr3)-octreotate/NaI3-octreotide(68Ga-DOTA-TATE/NOC) Positron Emission Tomography (PET)/Computed Tomography coronary angiography (CTCA), targeting the somatostatin receptor subtype-2 selectively expressed by M1 macrophages may show coronary inflammation. The SHORE protocol aims at evaluating the synergy between OCT and 68Ga-DOTA-TATE/NOC in predicting coronary plaque progression as assessed by CTCA
Conditions
- Acute Coronary Syndrome
- Atherosclerosis
- Inflammation
- Coronary Artery Disease
Interventions
- DIAGNOSTIC_TEST
-
coronary OCT
Intermediate coronary lesions will be evaluated by OCT
- DIAGNOSTIC_TEST
-
68GaDOTATATE PET/CTCA
Intermediate coronary lesions will be evaluated by68GaDOTATATE PET/CTCA
Sponsors & Collaborators
- collaborator OTHER
-
Centro per la Lotta Contro l'Infarto - Fondazione Onlus
collaborator OTHER -
University of Bologna
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-21
- Primary Completion
- 2024-06-21
- Completion
- 2024-06-21
Countries
- Italy
Study Locations
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