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This is a retrospective, single-center study to develop and validate an updated algorithm for computing fractional flow reserve from intravascular ultrasound images (IvusFFR v2.0). The study will use existing intravascular ultrasound (IVUS) images and corresponding invasive fractional flow reserve (FFR) measurements obtained from approximately 100 patients who underwent clinically indicated coronary angiography, IVUS, and FFR assessment at Fuwai Hospital. All data will be anonymized prior to analysis. The primary objective is to assess the diagnostic accuracy of IvusFFR v2.0 in identifying hemodynamically significant coronary stenosis, using wire-based FFR ≤0.80 as the reference standard. This study involves no prospective intervention or additional patient contact.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective IVUS-FFR Cohort | This single retrospective cohort consists of approximately 100 patients who underwent clinically indicated coronary angiography, intravascular ultrasound (IVUS) imaging, and invasive fractional flow reserve (FFR) measurement at Fuwai Hospital. All data were collected as part of routine clinical care and have been fully anonymized prior to analysis. The cohort includes both pre- and post-percutaneous coronary intervention (PCI) pullbacks where available. No prospective intervention or patient contact is involved. The dataset is used for algorithm development and validation of IvusFFR v2.0, a software for computing FFR from IVUS images. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention (Retrospective Data Analysis) | Other | This is a retrospective observational study. No prospective intervention is administered. Participants' existing IVUS images and FFR measurements are analyzed. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of IvusFFR v2.0 for Identifying Hemodynamically Significant Coronary Stenosis | Diagnostic accuracy of IvusFFR v2.0 in identifying hemodynamically significant coronary stenosis, using wire-based fractional flow reserve (FFR) ≤0.80 as the reference standard. Accuracy is defined as (True Positive + True Negative) / (Total Number of Vessels). | Through study completion, an average of 6 months |
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This retrospective study includes approximately 100 adult patients with suspected or known coronary artery disease who underwent clinically indicated invasive coronary angiography, intravascular ultrasound (IVUS) imaging, and fractional flow reserve (FFR) measurement at Fuwai Hospital. The cohort consists of patients with intermediate coronary lesions (30-90% diameter stenosis by visual estimation) for whom both anatomical assessment by IVUS and physiological assessment by FFR were deemed clinically necessary. Data were collected from existing medical records and imaging archives, and all personal identifiers have been removed prior to analysis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai hospital | Beijing | Select | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26347918 | Result | Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Kober L; DANAMI-3-PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71. doi: 10.1016/s0140-6736(15)60648-1. | |
| 28317428 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Result |
| Smits PC, Abdel-Wahab M, Neumann FJ, Boxma-de Klerk BM, Lunde K, Schotborgh CE, Piroth Z, Horak D, Wlodarczak A, Ong PJ, Hambrecht R, Angeras O, Richardt G, Omerovic E; Compare-Acute Investigators. Fractional Flow Reserve-Guided Multivessel Angioplasty in Myocardial Infarction. N Engl J Med. 2017 Mar 30;376(13):1234-1244. doi: 10.1056/NEJMoa1701067. Epub 2017 Mar 18. |
| 30596995 | Result | Zimmermann FM, Omerovic E, Fournier S, Kelbaek H, Johnson NP, Rothenbuhler M, Xaplanteris P, Abdel-Wahab M, Barbato E, Hofsten DE, Tonino PAL, Boxma-de Klerk BM, Fearon WF, Kober L, Smits PC, De Bruyne B, Pijls NHJ, Juni P, Engstrom T. Fractional flow reserve-guided percutaneous coronary intervention vs. medical therapy for patients with stable coronary lesions: meta-analysis of individual patient data. Eur Heart J. 2019 Jan 7;40(2):180-186. doi: 10.1093/eurheartj/ehy812. |
| 33541105 | Result | Yu W, Tanigaki T, Ding D, Wu P, Du H, Ling L, Huang B, Li G, Yang W, Zhang S, Yan F, Okubo M, Xu B, Matsuo H, Wijns W, Tu S. Accuracy of Intravascular Ultrasound-Based Fractional Flow Reserve in Identifying Hemodynamic Significance of Coronary Stenosis. Circ Cardiovasc Interv. 2021 Feb;14(2):e009840. doi: 10.1161/CIRCINTERVENTIONS.120.009840. Epub 2021 Feb 5. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |