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Background: the decision-making process of patients with angiographically-intermediate coronary lesions (ICL) is clinically challenging and may benefit from adjunctive invasive techniques. Fractional-flow-reserve (FFR) represents the gold standard to evaluate ICL but optical-coherence-tomography (OCT) is a novel, promising, high resolution coronary imaging technique.
Objectives:
Study design: multicentre, international, individual patient's level data pooled analysis.
Principal investigators that enrolled stable or unstable patients with ICL who underwent both FFR and OCT assessment of the same lesion, will be contacted to participate the study. Agreeing investigators will be asked to complete a structured database by providing a series of key baseline clinical and angiographic data, OCT and FFR parameters.
Collected dataset will include: sex, age, hypertension, diabetes, hypercholesterolemia, current smoking, family history of CAD, clinical presentation, previous PCI, previous MI, previous CABG, non-invasive ischemia, angina, n° of diseased vessels, diseased vessel, percentage diameter stenosis at quantitative coronary angiography (QCA% stenosis), length of stenosis at quantitative coronary angiography, presence of thrombus or ulceration, MLA, area stenosis at OCT, FFR protocol (intracoronary adenosine, endovenous adenosine, contrast) results and long term clinical follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optical coherence tomography (OCT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical coherence tomography (OCT) | Device | Lesion OCT assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| OCT measures predicting FFR - mean lumen area | ICL mean lumen area (MLA) | 1 day |
| OCT measure predicting FFR - area stenosis | ICL percentage area stenosis (AS) | 1 day |
| OCT measure predicting FFR - thrombus or ulceration | Presence of thrombus or ulceration at the level of ICL | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac Events (MACE) in untreated patients (no PCI or CABG) | Major Adverse Cardiac Events (MACE) defined as the composite of:
| 1 year |
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Inclusion Criteria:
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Stable or unstable patients with intermediate coronary lesions who underwent both FFR and OCT assessment of the same lesion
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico A. Gemelli. Università Cattolica del Sacro Cuore | Roma | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39091119 | Derived | Lombardi M, Vergallo R, Costantino A, Bianchini F, Kakuta T, Pawlowski T, Leone AM, Sardella G, Agostoni P, Hill JM, De Maria GL, Banning AP, Roleder T, Belkacemi A, Trani C, Burzotta F. Development of machine learning models for fractional flow reserve prediction in angiographically intermediate coronary lesions. Catheter Cardiovasc Interv. 2024 Sep;104(3):472-482. doi: 10.1002/ccd.31167. Epub 2024 Aug 1. |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |