Plaque vulnerability assessment: The purpose of the OCT-AGEM registry is to confirm the clinical utility of plaque OCT assessment over the standard coronary angiography evaluation. In particular, this ambispective cohort study aims to validate the predictive value of the OCT-based plaque vulnerability criteria:
* Minimum lumen area \<3.5 mm2;
* Fibrous cap minimum thickness \<65 µm;
* Lipid arc extension \>180°;
* Presence of macrophages;
* Superficial and deep calcified nodules
* Ulceration/Erosion/Dissection
* Layered tissue
* Optical flow ratio (OFR)
Stent implantation optimization: The purpose of the OCT-AGEM registry is to confirm the clinical utility of OCT guidance during PCI over the standard coronary angiography evaluation. In particular, this ambispective cohort study aims to validate the predictive value of the OCT-derived plaque/stent parameters reported in expert consensus OCT documents, utilizing the cut-off points identified in the previous OCT registries
Study summary
The starring optical coherence tomography during percutaneous coronary intervention guidance (OCT-AGEM) registry aims to evaluate the clinical impact of intra-procedural optical coherence tomography (OCT) in coronary revascularization, both in guiding revascularization decisions and optimizing interventional procedural outcomes, as well as assessing mid- and long-term clinical results.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age over 18 years;
* Patients with clinical indication to coronary angiography undergoing intra-procedural OCT regardless of the clinical syndrome;
* Patients with at least one end-procedural OCT assessment with a sufficient acquisition length to address the whole length of plaque or stented segments plus the proximal and distal reference segments;
* Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Ethical Committee of the respective clinical site.
Exclusion Criteria:
* Female with childbearing potential or lactating;
* Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl and/or glomerular filtration rate \<30 ml/min);
* Advanced heart failure (NYHA III-IV);
* Previous heart transplantation;
* Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;
* Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;
* Heavily calcified lesion or tortuous vessel which cannot be successfully imaged by OCT;
* Lesion located at the coronary ostium or in angulated (\>70°), sharp take-off vessel;
Primary outcome measure(s)
Number of patients with cardiac death or target-vessel myocardial infarction or target lesion revascularization (non-interventional group) — 1 year, 3 years, and 5 years Composite outcome including cardiac death (i.e. any death due to heart disease, including heart failure, myocardial infarction, arrhythmia, and sudden unexpected death), target-vessel myocardial infarction (i.e. any spontaneous myocardial infarction attributed to the vessel studied with OCT), and target lesion revascularization (i.e. any target-lesion revascularization by means of percutaneous coronary intervention and coronary artery bypass grafting).
Number of patients with cardiac death or target-vessel myocardial infarction or target lesion revascularization or stent restenosis/thrombosis (interventional group) — 1 year, 3 years, and 5 years Composite outcome including cardiac death (i.e. any death due to heart disease, including heart failure, myocardial infarction, arrhythmia, and sudden unexpected death), target-vessel myocardial infarction (i.e. any spontaneous myocardial infarction attributed to the vessel studied with OCT), target lesion revascularization (i.e. any target-lesion revascularization by means of percutaneous coronary intervention and coronary artery bypass grafting), and stent restenosis (i.e. angiographic in-stent stenosis/thrombosis \>50%).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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