An observational study in Acute Coronary Syndromes (ACS), Chronic Coronary Syndrome and MINOCA, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
The OCT-AGEM registry is an ambispective, single-center observational cohort study comprising a retrospective registry (Phase I) and a prospective registry (Phase II). All patients aged 18 years or older undergoing OCT assessment during a clinically indicated coronary angiography, regardless of clinical presentation (silent ischemia, stable angina, or acute coronary syndrome), are eligible. The retrospective phase targets approximately 2,200 patients, while the prospective phase will enroll 1,000 patients, based on a current annual rate of about 150 OCT-guided procedures. Sample size calculations, informed by prior studies and preliminary experience, are as follows: for the non-interventional arm, assuming a 5% cumulative incidence of the composite endpoint and a 20% prevalence of OCT-defined vulnerable plaque, a total of 1,100 patients is required (hazard ratio [HR] 0.80; 80% power); for the interventional arm, assuming a 25% incidence of OCT-defined suboptimal stent implantation and 12% for the composite endpoint, a total of 2,100 patients will be enrolled (HR 0.85; 80% power). The study will investigate the predictive clinical value of OCT-defined vulnerable plaque in patients with non-obstructive coronary artery disease (MINOCA/INOCA) and the prognostic impact of OCT-derived plaque and stent parameters in patients undergoing percutaneous coronary intervention (PCI). The primary composite endpoint includes cardiac death, target-vessel myocardial infarction, target lesion revascularization, and stent thrombosis
1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.
This study's planned enrollment of 3,200 is above the median of 500 across 590 observational studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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All subjects over 18 years who are undergoing an OCT coronary assessment during clinically indicated coronary angiogram regardless of the clinical syndrome (silent ischemia, effort angina or acute coronary syndrome).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing an OCT coronary assessment during a clinically indicated coronary angiogram, resulting in a non-obstructive coronary artery disease
Diagnostic Test: Plaque vulnerability assessment
Patients undergoing an OCT coronary assessment during a clinically indicated coronary angiogram, guiding a percutaneous coronary intervention
Diagnostic Test: Stent implantation optimization
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)
Also known as: Minimum lumen area, Fibrous cap minimum thickness, Lipid arc extension, Presence of macrophages, Superficial and deep calcified nodules, Ulceration/Erosion/Dissection, Layered tissue, Plaque burden (%), Optical flow ratio (OFR)
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
Also known as: Minimum lumen area, Fibrous cap minimum thickness, Lipid arc extension, Presence of macrophages, Superficial and deep calcified nodules, Ulceration/Erosion/Dissection, Layered tissue, Plaque burden (%), Stent edge dissection, Reference narrowing, Stent malapposition, Minimum stent area, Stent expansion (%), In-stent tissue protrusion, Stent deformation, Stent geometry, Neo-carina shaping, Optical flow ratio (OFR)
Number of patients with cardiac death or target-vessel myocardial infarction or target lesion revascularization (non-interventional group)
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).
Time frame: 1 year, 3 years, and 5 years
Number of patients with cardiac death or target-vessel myocardial infarction or target lesion revascularization or stent restenosis/thrombosis (interventional group)
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%).
Time frame: 1 year, 3 years, and 5 years
Predictive value of single vulnerable plaque OCT-derived criteria (non-interventional and interventional group) in terms of incidence of the primary and secondary outcomes
Clinical impact of the single pre-specified OCT features of plaque vulnerability: * Minimum lumen area \<3.5 mm2 (measured along the entire length of the assessed coronary segment ); * Fibrous cap minimum thickness \<65 µm (defined as a signal-rich homogeneous band overlying a lipid core, and measured at the thinnest portion); * Lipid arc extension \>180° (defined as a signal-poor region diffusely bordered by overlying signal-rich bands corresponding to a fibrous cap); * Presence of macrophages (characterized at visual estimation as signal-rich, distinct, or confluent punctate regions that exceed the intensity of background speckle noise); * Superficial and deep calcified nodules (protruding mass with irregular surface characterized by signal-poor heterogeneous regions with sharp borders) * Ulceration/Erosion/Dissection (linear rim of tissue with a width ≥200μm and a clear separation from the vessel wall or underlying plaque) * Layered tissue (plaque with one or more evident layers)
Time frame: 1 year, 3 years, and 5 years
Predictive clinical value of single pre-specified plaque/stent OCT features in patients undergoing percutaneous coronary revascularization (interventional group) in terms of incidence of the primary and secondary outcomes
Clinical impact of the single pre-specified OCT features of the stented plaques: * Edge dissection with a width ≥200μm (linear rim of tissue with a width ≥200μm and a clear separation from the vessel wall or underlying plaque); * Reference narrowing: lumen area \<4.5mm2 in the presence of significant residual plaque adjacent to stent endings (including 5mm beyond stent borders); * Malapposition \>200μm (stent-adjacent vessel lumen distance \>200μm); * In-stent minimum lumen area (MLA) \<4.5mm2 (measure of smaller in-stent lumen area); * In-stent MLA \<80% (expressed as % of the average reference lumen areas); * Intrastent plaque/thrombus protrusion ≥500μm in thickness (tissue prolapsing between stent struts extending inside a circular arc connecting adjacent struts or intraluminal mass ≥500μm in thickness with no direct continuity with the surface of the vessel wall or highly backscattered luminal protrusion in continuity with the vessel wall and resulting in signal-free shadowing).
Time frame: 1 year, 3 years, and 5 years
Number of patients with cardiac death
Cardiac death will be defined as any death due to heart disease, including heart failure, myocardial infarction, arrhythmia, and sudden unexpected death.
Time frame: 1 year, 3 years, and 5 years
Number of patients with non-fatal spontaneous target-vessel myocardial infarction (excluding peri-procedural myocardial infarction)
Any spontaneous myocardial infarction will be attributed to the target vessel if not clearly attributable to the non-target vessels.
Time frame: 1 year, 3 years, and 5 years
Number of patients with target lesion revascularization
Any lesion revascularization will be considered in case of percutaneous coronary intervention or coronary artery bypass grafting of the studied lesion.
Time frame: 1 year, 3 years, and 5 years
Number of patients with restenosis or thrombosis of the target lesion
Any revascularization procedure performed because of angiographic restenosis/thrombosis \>50% at the site of the target lesion associated with clinical or objective evidence of inducible myocardial ischemia
Time frame: 1 year, 3 years, and 5 years
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
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