Synergy Between morpHOlogical and inflammatoRy Evaluation in Predicting Long-term Coronary Plaque… (NCT05436977) | Clinical Trial Compass
CompletedNot Applicable
Synergy Between morpHOlogical and inflammatoRy Evaluation in Predicting Long-term Coronary Plaque Progression
Italy40 participantsStarted 2021-06-21
Plain-language 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
Who can participate
Age range50 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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.