Definition of Intra-procedural Optical Coherence Tomography (OCT) Clinical Impact, Both in Terms of Revascularization Indication and Procedural Result.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 3,200
- Locations
- 1
- Primary Endpoint
- Number of patients with cardiac death or target-vessel myocardial infarction or target lesion revascularization (non-interventional group)
Study Overview
Brief 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.
Detailed Description
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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;
Outcomes
Primary Outcomes
Number of patients with cardiac death or target-vessel myocardial infarction or target lesion revascularization (non-interventional group)
Time Frame: 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)
Time Frame: 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%).
Secondary Outcomes
- Predictive value of single vulnerable plaque OCT-derived criteria (non-interventional and interventional group) in terms of incidence of the primary and secondary outcomes(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(1 year, 3 years, and 5 years)
- Number of patients with cardiac death(1 year, 3 years, and 5 years)
- Number of patients with non-fatal spontaneous target-vessel myocardial infarction (excluding peri-procedural myocardial infarction)(1 year, 3 years, and 5 years)
- Number of patients with target lesion revascularization(1 year, 3 years, and 5 years)
- Number of patients with restenosis or thrombosis of the target lesion(1 year, 3 years, and 5 years)
Investigators
Romagnoli Enrico
Clinical Physician, Principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS