Spektral- och Ultra-Högupplösnings-CT-system för icke-invasiv detektion av myokardischemi: Stress-CT-perfusion vs. FFr-CT (SURE-CT)
16 september 2026 uppdaterad av: Anna Palmisano, IRCCS San Raffaele
Spectrala och ultra högupplösta CT-system för icke-invasiv detektering av myokardischemi: Stress-CT-perfusion vs. FFR-CT
Coronary artery disease (CAD) is the leading cause of mortality and morbidity worldwide. Coronary Computed Tomography angiography (CCTA) gained a pivotal clinical role for excellent sensitivity in rule-out CAD, but has limited specificity for a tendency to overestimate stenoses and for the lack of information about their hemodynamic impact. Fractional Flow Reserve derived from CT (FFR-CT) and stress CT perfusion (CTP) have been recently proposed to complement CCTA in the non-invasive assessment of myocardial ischemia, increasing the specificity and avoiding unnecessary catheterization. However, on energy-integrating (EID)-CT, FFR-CT has suboptimal performance, while CTP is affected by high radiation exposure. Both these approaches may benefit by the introduction of the new Photon Counting Detector (PCD)-CT technology, but data completely lacks. Aim of the study is to assess the performance of PCD-CT in the identification of significant CAD combining CCTA with FFR-CT and spectral CTP.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Studietyp
Observationell
Inskrivning (Beräknad)
142
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Anna Palmisano, Medicine and Surgery
- Telefonnummer: +39 3200985665
- E-post: palmisano.anna@hsr.it
Studera Kontakt Backup
- Namn: Davide Vignale, Medicine and Surgery
- Telefonnummer: +39 3480521191
- E-post: vignale.davide@hsr.it
Studieorter
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-
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Milan, Italien
- IRCCS Ospedale San Raffaele
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RM
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Roma, RM, Italien, 00189
- Azienda Ospedaliero-Universitaria Sant'Andrea
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Kontakt:
- Damiano Caruso, Medicine and Surgery
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
142 patients (age>18 years old) referred to our hospitals for elective CCTA for ruling out CAD and CCTA evidence of moderate stenosis (50-69%) requiring functional assessment according to ESC guidelines (1) because is known that not all anatomical stenosis in the range of moderate (50-69%) are haemodynamically significant (2) or induce myocardial ischaemia (3).
Beskrivning
Inclusion Criteria:
- Patient referred to our hospitals for elective CCTA for ruling out CAD
- CCTA evidence of moderate stenosis (50-69%) requiring functional assessment according to ESC guidelines
Exclusion Criteria:
- hemodynamically unstable conditions,
- previous revascularization,
- myocardial infarction,
- obesity (BMI>40 kg/m2),
- renal insufficiency (GFR<30 mL/min),
- atrial fibrillation or other significant arrhythmias; and
- other overt cardiovascular diseases affecting CTP performance (e.g., heart failure, severe valvular regurgitation),
- pregnancy and breastfeeding,
- contraindications to iodinated contrast agents or regadenoson.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Diagnostic accuracy of CCTA, CCTA plus FFR-CT, and CCTA plus spectral stress CT perfusion in the detection of hemodynamically relevant coronary stenosis
Tidsram: 36 months
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CCTA-derived stenosis and plaque characterization; CT-FFR values from commercial and in-house solutions; CTP-derived iodine uptake measurement; invasive FFR as reference standard. Comparison of off-site versus on-site CT-FFR solutions determined against invasive FFR. |
36 months
|
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Evaluation of rest spectral CT perfusion for the assessment of haemodynamic significance of stenosis
Tidsram: 36 months
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Coronary stenosis severity at CCTA; myocardial iodine uptake at baseline, rest, and stress CTP; diagnostic performance of iodine uptake values against invasive FFR. |
36 months
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Identification of geometric features from PCD-CT ultra high resolution CCTA associated to plaque-specific ischemia at invasive FFR.
Tidsram: 36 months
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Blinded analysis of baseline CCTA for qualitative and quantitative plaque characteristics, with correlation to invasive FFR. Inter-rater agreement assessment between two expert readers. Deep learning-based radiomic feature extraction from plaques and vessel walls. Development of a data-driven feature selection pipeline to predict hemodynamically significant stenosis from CCTA data, using invasive FFR as reference. |
36 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Whiting PF, Rutjes AW, Westwood ME, Mallett S, Deeks JJ, Reitsma JB, Leeflang MM, Sterne JA, Bossuyt PM; QUADAS-2 Group. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med. 2011 Oct 18;155(8):529-36. doi: 10.7326/0003-4819-155-8-201110180-00009.
- Cohen JF, Korevaar DA, Altman DG, Bruns DE, Gatsonis CA, Hooft L, Irwig L, Levine D, Reitsma JB, de Vet HC, Bossuyt PM. STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration. BMJ Open. 2016 Nov 14;6(11):e012799. doi: 10.1136/bmjopen-2016-012799.
- Collins GS, Reitsma JB, Altman DG, Moons KG. Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): the TRIPOD Statement. BMC Med. 2015 Jan 6;13:1. doi: 10.1186/s12916-014-0241-z.
- Tonino PA, Fearon WF, De Bruyne B, Oldroyd KG, Leesar MA, Ver Lee PN, Maccarthy PA, Van't Veer M, Pijls NH. Angiographic versus functional severity of coronary artery stenoses in the FAME study fractional flow reserve versus angiography in multivessel evaluation. J Am Coll Cardiol. 2010 Jun 22;55(25):2816-21. doi: 10.1016/j.jacc.2009.11.096.
- Schuijf JD, Wijns W, Jukema JW, Atsma DE, de Roos A, Lamb HJ, Stokkel MP, Dibbets-Schneider P, Decramer I, De Bondt P, van der Wall EE, Vanhoenacker PK, Bax JJ. Relationship between noninvasive coronary angiography with multi-slice computed tomography and myocardial perfusion imaging. J Am Coll Cardiol. 2006 Dec 19;48(12):2508-14. doi: 10.1016/j.jacc.2006.05.080. Epub 2006 Nov 28.
- Palmisano A, Vignale D, Tadic M, Moroni F, De Stefano D, Gatti M, Boccia E, Faletti R, Oppizzi M, Peretto G, Slavich M, Sala S, Montorfano M, Agricola E, Margonato A, De Cobelli F, Gentile F, Robella M, Cortese G, Esposito A. Myocardial Late Contrast Enhancement CT in Troponin-Positive Acute Chest Pain Syndrome. Radiology. 2022 Mar;302(3):545-553. doi: 10.1148/radiol.211288. Epub 2021 Dec 7.
- Cury RC, Leipsic J, Abbara S, Achenbach S, Berman D, Bittencourt M, Budoff M, Chinnaiyan K, Choi AD, Ghoshhajra B, Jacobs J, Koweek L, Lesser J, Maroules C, Rubin GD, Rybicki FJ, Shaw LJ, Williams MC, Williamson E, White CS, Villines TC, Blankstein R. CAD-RADS 2.0 - 2022 Coronary Artery Disease-Reporting and Data System: An Expert Consensus Document of the Society of Cardiovascular Computed Tomography (SCCT), the American College of Cardiology (ACC), the American College of Radiology (ACR), and the North America Society of Cardiovascular Imaging (NASCI). J Cardiovasc Comput Tomogr. 2022 Nov-Dec;16(6):536-557. doi: 10.1016/j.jcct.2022.07.002. Epub 2022 Jul 8.
- Correction to: 2024 ESC Guidelines for the management of chronic coronary syndromes: Developed by the task force for the management of chronic coronary syndromes of the European Society of Cardiology (ESC) Endorsed by the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2025 Apr 22;46(16):1565. doi: 10.1093/eurheartj/ehaf079. No abstract available.
- De Santis D, Del Gaudio A, Santangeli C, Fanelli F, Pacelli F, Capece Minutolo Del Sasso L, Zerunian M, Polici M, Polidori T, Pucciarelli F, Marin D, Laghi A, Caruso D. Every Drop (Photon) Counts: Current Applications and Future Challenges of Photon-Counting Detector CT in Abdominal Imaging. Invest Radiol. 2025 Oct 1;60(10):647-657. doi: 10.1097/RLI.0000000000001178.
- Caruso D, Eid M, Schoepf UJ, Jin KN, Varga-Szemes A, Tesche C, Mangold S, Spandorfer A, Laghi A, De Cecco CN. Dynamic CT myocardial perfusion imaging. Eur J Radiol. 2016 Oct;85(10):1893-1899. doi: 10.1016/j.ejrad.2016.07.017. Epub 2016 Aug 3.
- Caruso D, DE Santis D, Schoepf UJ, Zerunian M, Eid M, Varga-Szemes A, Tesche C, Duguay TM, Laghi A, DE Cecco CN. CT myocardial perfusion: state of the science. Minerva Cardioangiol. 2017 Jun;65(3):252-264. doi: 10.23736/S0026-4725.16.04281-X. Epub 2016 Dec 13.
- Ghizzoni G, Ancona MB, Romano V, Bellini B, Ferri L, Russo F, Vella C, Gentile D, Chionchio G, Macelletti V, Ancona F, Agricola E, Palmisano A, Esposito A, Montorfano M. Mind the "commissural drop" when crossing the aortic valve! Catheter Cardiovasc Interv. 2023 Sep;102(3):538-541. doi: 10.1002/ccd.30763. Epub 2023 Jul 18. No abstract available.
- Bellini B, Romano V, Zanda G, Iannopollo G, De Ferrari T, Bijlsma E, Napoli F, Vella C, Gentile D, Ghizzoni G, Ferri LA, Russo F, Ancona MB, Ancona F, Agricola E, Palmisano A, Esposito A, Montorfano M. Clinical Outcomes of Patients With Bicuspid Aortic Valve Undergoing a Targeted Transcatheter Aortic Valve Replacement Approach: The LIRA Method. Can J Cardiol. 2025 May;41(5):831-839. doi: 10.1016/j.cjca.2024.12.006. Epub 2024 Dec 10.
- Ferri LA, Ancona MB, Papageorgiou C, Vella C, Capuano S, Romano V, Russo F, Bellini B, Zanda G, Gentile D, Ghizzoni G, Napoli F, Federico F, Agricola E, Palmisano A, Esposito A, Montorfano M. Computed tomography derived predictors of left ventricular obstruction after TAVR. Int J Cardiol. 2025 Mar 1;422:132956. doi: 10.1016/j.ijcard.2024.132956. Epub 2025 Jan 5.
- Palmisano A, Vignale D, Boccia E, Nonis A, Gnasso C, Leone R, Montagna M, Nicoletti V, Bianchi AG, Brusamolino S, Dorizza A, Moraschini M, Veettil R, Cereda A, Toselli M, Giannini F, Loffi M, Patelli G, Monello A, Iannopollo G, Ippolito D, Mancini EM, Pontone G, Vignali L, Scarnecchia E, Iannacone M, Baffoni L, Sperandio M, de Carlini CC, Sironi S, Rapezzi C, Antiga L, Jagher V, Di Serio C, Furlanello C, Tacchetti C, Esposito A. AI-SCoRE (artificial intelligence-SARS CoV2 risk evaluation): a fast, objective and fully automated platform to predict the outcome in COVID-19 patients. Radiol Med. 2022 Sep;127(9):960-972. doi: 10.1007/s11547-022-01518-0. Epub 2022 Aug 29.
- Esposito A, Palmisano A, Antunes S, Colantoni C, Rancoita PMV, Vignale D, Baratto F, Della Bella P, Del Maschio A, De Cobelli F. Assessment of Remote Myocardium Heterogeneity in Patients with Ventricular Tachycardia Using Texture Analysis of Late Iodine Enhancement (LIE) Cardiac Computed Tomography (cCT) Images. Mol Imaging Biol. 2018 Oct;20(5):816-825. doi: 10.1007/s11307-018-1175-1.
- Muscogiuri G, Palumbo P, Kitagawa K, Nakamura S, Senatieri A, De Cecco CN, Gershon G, Chierchia G, Usai J, Sferratore D, D'Angelo T, Guglielmo M, Dell'Aversana S, Jankovic S, Salgado R, Saba L, Cau R, Marra P, Di Cesare E, Sironi S. State of the art of CT myocardial perfusion. Radiol Med. 2025 Mar;130(3):438-452. doi: 10.1007/s11547-024-01942-4. Epub 2024 Dec 20.
- Soschynski M, Storelli R, Birkemeyer C, Hagar MT, Faby S, Schwemmer C, Nous FMA, Pugliese F, Vliegenthart R, Schlett CL, Nikolaou K, Krumm P, Nieman K, Bamberg F, Artzner CP. CT Myocardial Perfusion and CT-FFR versus Invasive FFR for Hemodynamic Relevance of Coronary Artery Disease. Radiology. 2024 Aug;312(2):e233234. doi: 10.1148/radiol.233234.
- Magalhaes TA, Cury RC, Pereira AC, Moreira Vde M, Lemos PA, Kalil-Filho R, Rochitte CE. Additional value of dipyridamole stress myocardial perfusion by 64-row computed tomography in patients with coronary stents. J Cardiovasc Comput Tomogr. 2011 Nov-Dec;5(6):449-58. doi: 10.1016/j.jcct.2011.10.013. Epub 2011 Nov 4.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 april 2029
Avslutad studie (Beräknad)
1 september 2029
Studieregistreringsdatum
Först inskickad
15 april 2026
Först inskickad som uppfyllde QC-kriterierna
15 april 2026
Första postat (Faktisk)
22 april 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
21 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 september 2026
Senast verifierad
1 april 2026
Mer information
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Andra studie-ID-nummer
- GR-2024-12380180
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