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Acute Coronary Syndromes (ACS)OCT-AGEMNCT07182799

Starring Optical Coherence Tomography During Percutaneous Coronary Intervention Guidance

An observational study of Acute Coronary Syndromes (ACS) and Chronic Coronary Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Plaque vulnerability assessment and Stent implantation optimization
How many people
3,200 participants
Where
1 siteItaly
Study dates
1 Sep 2025to 1 Sep 2036
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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).

Who may be able to join

  • 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.

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

    Rome, 00168

Other trials in Italy

About this study

Official title: Definition of Intra-procedural Optical Coherence Tomography (OCT) Clinical Impact, Both in Terms of Revascularization Indication and Procedural Result.

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.

Read the 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

Being tested
Plaque vulnerability assessment, Stent implantation optimization
Keywords
Percutaneous coronary intervention, Optical Coherence Tomography, Acute coronary syndrome, Chronic coronary syndrome, Clinical outcome, Coronary plaque, Coronary stent optimization
Medical subject headings
Acute Coronary Syndrome, MINOCA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Plaque vulnerability assessmentDiagnostic test

    Also called Minimum lumen area, Fibrous cap minimum thickness, Lipid arc extension, Presence of macrophages

    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 optimizationDiagnostic test

    Also called Minimum lumen area, Fibrous cap minimum thickness, Lipid arc extension, Presence of macrophages

    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 groups in NCT07182799
Study groupRoleWhat they receive
Non-interventionalPatients undergoing an OCT coronary assessment during a clinically indicated coronary angiogram, resulting in a non-obstructive coronary artery disease
Receives: Diagnostic Test: Plaque vulnerability assessment
InterventionalPatients undergoing an OCT coronary assessment during a clinically indicated coronary angiogram, guiding a percutaneous coronary intervention
Receives: Diagnostic Test: Stent implantation optimization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 1 year, 3 years, and 5 years

  2. 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%).

    Measured: 1 year, 3 years, and 5 years

Secondary outcomes (6)

  1. 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)

    Measured: 1 year, 3 years, and 5 years

  2. 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).

    Measured: 1 year, 3 years, and 5 years

  3. 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.

    Measured: 1 year, 3 years, and 5 years

  4. 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.

    Measured: 1 year, 3 years, and 5 years

  5. 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.

    Measured: 1 year, 3 years, and 5 years

  6. 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

    Measured: 1 year, 3 years, and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2025
  2. Study start1 Sep 2025
  3. Primary completion1 Sep 2031 (estimated)
  4. Study completion1 Sep 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
3,200 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07182799
Sponsor's protocol ID
7262
Acronym
OCT-AGEM
Status last verified
Sep 2025
First submitted
2 Sep 2025
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Prati F, Romagnoli E, Gatto L, La Manna A, Burzotta F, Limbruno U, Versaci F, Fabbiocchi F, Di Giorgio A, Marco V, Ramazzotti V, Di Vito L, Trani C, Porto I, Boi A, Tavazzi L, Mintz GS. Clinical Impact of Suboptimal Stenting and Residual Intrastent Plaque/Thrombus Protrusion in Patients With Acute Coronary Syndrome: The CLI-OPCI ACS Substudy (Centro per la Lotta Contro L'Infarto-Optimization of Percutaneous Coronary Intervention in Acute Coronary Syndrome). Circ Cardiovasc Interv. 2016 Dec;9(12):e003726. doi: 10.1161/CIRCINTERVENTIONS.115.003726.

    PubMed 27965297

  • Romagnoli E, Gatto L, La Manna A, Burzotta F, Taglieri N, Saia F, Amico F, Marco V, Ramazzotti V, Di Giorgio A, Di Vito L, Boi A, Contarini M, Castriota F, Mintz GS, Prati F. Role of residual acute stent malapposition in percutaneous coronary interventions. Catheter Cardiovasc Interv. 2017 Oct 1;90(4):566-575. doi: 10.1002/ccd.26974. Epub 2017 Mar 15.

    PubMed 28295990

  • Prati F, Romagnoli E, La Manna A, Burzotta F, Gatto L, Marco V, Fineschi M, Fabbiocchi F, Versaci F, Trani C, Tamburino C, Alfonso F, Mintz GS. Long-term consequences of optical coherence tomography findings during percutaneous coronary intervention: the Centro Per La Lotta Contro L'infarto - Optimization Of Percutaneous Coronary Intervention (CLI-OPCI) LATE study. EuroIntervention. 2018 Jul 20;14(4):e443-e451. doi: 10.4244/EIJ-D-17-01111.

    PubMed 29633940

  • Gatto L, Alfonso F, Paoletti G, Burzotta F, La Manna A, Budassi S, Biccire FG, Fineschi M, Marco V, Fabbiocchi F, Vergallo R, Boi A, Ruscica G, Versaci F, Taglieri N, Calligaris G, Albertucci M, Romagnoli E, Ramazzotti V, Tamburino C, Crea F, Ozaki Y, Arbustini E, Prati F. Relationship betweeen the amount and location of macrophages and clinical outcome: subanalysis of the CLIMA-study. Int J Cardiol. 2022 Jan 1;346:8-12. doi: 10.1016/j.ijcard.2021.11.042. Epub 2021 Nov 17.

    PubMed 34798205

  • Prati F, Romagnoli E, Biccire FG, Burzotta F, La Manna A, Budassi S, Ramazzotti V, Albertucci M, Fabbiocchi F, Sticchi A, Trani C, Calligaris G, Fineschi M, Versaci F, Tamburino C, Ozaki Y, Alfonso F, Mintz GS. Clinical outcomes of suboptimal stent deployment as assessed by optical coherence tomography: long-term results of the CLI-OPCI registry. EuroIntervention. 2022 Jun 3;18(2):e150-e157. doi: 10.4244/EIJ-D-21-00627.

    PubMed 34825652

  • Romagnoli E, Ramazzotti V, Burzotta F, Gatto L, Marco V, Paoletti G, Biondi-Zoccai G, Alfonso F, Crea F, Trani C, Prati F; CLI-OPCI Project Investigators*. Definition of Optimal Optical Coherence Tomography-Based Stent Expansion Criteria: In-Stent Minimum Lumen Area Versus Residual Stent Underexpansion. Circ Cardiovasc Interv. 2022 Sep;15(9):e011496. doi: 10.1161/CIRCINTERVENTIONS.121.011496. Epub 2022 Sep 20.

    PubMed 36126136

  • Romagnoli E, Burzotta F, Vergallo R, Gatto L, Biondi-Zoccai G, Ramazzotti V, Biccire F, Budassi S, Trani C, Ali Z, Stone GW, Prati F. Clinical impact of OCT-derived suboptimal stent implantation parameters and definitions. Eur Heart J Cardiovasc Imaging. 2023 Dec 21;25(1):48-57. doi: 10.1093/ehjci/jead172.

    PubMed 37463223

  • Biccire FG, Fabbiocchi F, Gatto L, La Manna A, Ozaki Y, Romagnoli E, Marco V, Boi A, Fineschi M, Piedimonte G, Cerrato E, Musto C, Taglieri N, Di Giorgio A, Vizzari G, Ruscica G, Canova PA, Vergallo R, Burzotta F, Limbruno U, Albertucci M, Raber L, Crea F, Alfonso F, Arbustini E, Stone GW, Prati F. Long-Term Prognostic Impact of OCT-Derived High-Risk Plaque Features: Extended Follow-Up of the CLIMA Study. JACC Cardiovasc Interv. 2025 Jun 9;18(11):1361-1372. doi: 10.1016/j.jcin.2025.04.044.

    PubMed 40500004

  • Tanigawa J, Barlis P, Di Mario C. Intravascular optical coherence tomography: optimisation of image acquisition and quantitative assessment of stent strut apposition. EuroIntervention. 2007 May;3(1):128-36.

    PubMed 19737696

  • Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007 May 8;115(18):2435-41. doi: 10.1161/CIRCULATIONAHA.107.693739. Epub 2007 Apr 16.

    PubMed 17438147

  • Niccoli G, Montone RA, Di Vito L, Gramegna M, Refaat H, Scalone G, Leone AM, Trani C, Burzotta F, Porto I, Aurigemma C, Prati F, Crea F. Plaque rupture and intact fibrous cap assessed by optical coherence tomography portend different outcomes in patients with acute coronary syndrome. Eur Heart J. 2015 Jun 7;36(22):1377-84. doi: 10.1093/eurheartj/ehv029. Epub 2015 Feb 18.

    PubMed 25713314

  • Prati F, Uemura S, Souteyrand G, Virmani R, Motreff P, Di Vito L, Biondi-Zoccai G, Halperin J, Fuster V, Ozaki Y, Narula J. OCT-based diagnosis and management of STEMI associated with intact fibrous cap. JACC Cardiovasc Imaging. 2013 Mar;6(3):283-7. doi: 10.1016/j.jcmg.2012.12.007.

    PubMed 23473109

  • Souteyrand G, Arbustini E, Motreff P, Gatto L, Di Vito L, Marco V, Amabile N, Chisari A, Kodama T, Romagnoli E, Tavazzi L, Crea F, Narula J, Prati F. Serial optical coherence tomography imaging of ACS-causing culprit plaques. EuroIntervention. 2015 Jul;11(3):319-24. doi: 10.4244/EIJV11I3A59.

    PubMed 26196754

  • Tearney GJ, Regar E, Akasaka T, Adriaenssens T, Barlis P, Bezerra HG, Bouma B, Bruining N, Cho JM, Chowdhary S, Costa MA, de Silva R, Dijkstra J, Di Mario C, Dudek D, Falk E, Feldman MD, Fitzgerald P, Garcia-Garcia HM, Gonzalo N, Granada JF, Guagliumi G, Holm NR, Honda Y, Ikeno F, Kawasaki M, Kochman J, Koltowski L, Kubo T, Kume T, Kyono H, Lam CC, Lamouche G, Lee DP, Leon MB, Maehara A, Manfrini O, Mintz GS, Mizuno K, Morel MA, Nadkarni S, Okura H, Otake H, Pietrasik A, Prati F, Raber L, Radu MD, Rieber J, Riga M, Rollins A, Rosenberg M, Sirbu V, Serruys PW, Shimada K, Shinke T, Shite J, Siegel E, Sonoda S, Suter M, Takarada S, Tanaka A, Terashima M, Thim T, Uemura S, Ughi GJ, van Beusekom HM, van der Steen AF, van Es GA, van Soest G, Virmani R, Waxman S, Weissman NJ, Weisz G; International Working Group for Intravascular Optical Coherence Tomography (IWG-IVOCT). Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation. J Am Coll Cardiol. 2012 Mar 20;59(12):1058-72. doi: 10.1016/j.jacc.2011.09.079.

    PubMed 22421299

  • Prati F, Guagliumi G, Mintz GS, Costa M, Regar E, Akasaka T, Barlis P, Tearney GJ, Jang IK, Arbustini E, Bezerra HG, Ozaki Y, Bruining N, Dudek D, Radu M, Erglis A, Motreff P, Alfonso F, Toutouzas K, Gonzalo N, Tamburino C, Adriaenssens T, Pinto F, Serruys PW, Di Mario C; Expert's OCT Review Document. Expert review document part 2: methodology, terminology and clinical applications of optical coherence tomography for the assessment of interventional procedures. Eur Heart J. 2012 Oct;33(20):2513-20. doi: 10.1093/eurheartj/ehs095. Epub 2012 May 31. No abstract available.

    PubMed 22653335

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndromes (ACS) and Chronic Coronary Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07182799, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

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