Impact of Stress CT Myocardial Perfusion on Downstream Resources and Prognosis (CTP-PRO)
1 czerwca 2026 zaktualizowane przez: Gianluca Pontone, MD, PhD, Centro Cardiologico Monzino
Impact of Stress Cardiac Computed Tomography Myocardial Perfusion on Downstream Resources and PROgnosis in Patients With Suspected or Known Coronary Artery Disease: a Multicenter International Study
CT myocardial perfusion imaging (CTP) represents one of the newly developed CT-based techniques but its cost-effectiveness in the clinical pathway is undefined.
The aim of the study is to evaluate the usefulness of combined evaluation of coronary anatomy and myocardial perfusion in intermediate to high-risk patients for suspected CAD or with known disease in terms of clinical decision-making, resource utilization and outcomes in a broad variety of geographic areas and patient subgroups.
Przegląd badań
Status
Aktywny, nie rekrutujący
Szczegółowy opis
The use of cardiac computed tomography angiography (CCTA) is usually suggested in low to intermediate risk for its diagnostic and prognostic role to rule out CAD with low radiation exposure. In the setting of intermediate to high risk patients, the addition of functional information is prognostically useful and, in patients with previous history of percutaneous coronary intervention (PCI), functional strategy has been shown to be more cost-effective as compared to anatomical assessment CT myocardial perfusion imaging (CTP) represents one of the newly developed CT-based techniques, combining both anatomical and functional evaluation of CAD in a single imaging modality. More recently, stress CTP was shown to provide additional diagnostic value as compared to CCTA alone in intermediate to high risk patients. The purpose of this study will be to evaluate the usefulness and impact of combined evaluation of coronary artery anatomy and myocardial perfusion with CCTA+CTP in intermediate to high risk patients for suspected CAD or with known disease in terms of clinical decision-making, resource utilization, and outcomes in a broad variety of geographic areas and patient subgroups.
CTP-PRO study is a cooperative, international, multicentre, prospective, open-label, randomized controlled study evaluating the cost-effectiveness of a CCTA+CTP strategy versus usual care in intermediate to high risk patients with suspected or known CAD who undergo clinically indicated diagnostic evaluation.
Patients will be screened for study eligibility. Patients meeting all selection criteria will be asked to sign an informed consent document prior to undergoing any study-specific evaluation; then a structured interview will be performed and a clinical history obtained, assessing the presence of common cardiac risk factors, drug therapy (focus on statin, aspirin and/or antiplatelet agent use) and symptoms (typical or atypical angina, to estimate the pre-test likelihood of CAD).
Upon completion of the screening procedure and enrollment, the patients will be randomized 1:1 to the CT-based strategy (Group A) or usual care (Group B). Patient follow-up will be performed at 1 year (± 1 month) and 2 years (± 1 month) by trained interviewers who check medical records or by phone interview collecting the following information: downstream testing; overall radiation exposure; outcomes; cost-effectiveness estimation.
The primary endpoint of the study is the reclassification rate of CCTA in group B due to the addition of CTP. The secondary endpoint will be the comparison between group A and group B in terms of non-invasive and invasive downstream testing, prevalence of obstructive CAD at ICA, revascularization, cumulative ED and overall cost during the follow-up at 1- and 2-years. The tertiary endpoint will be the comparison between each group in terms of MACE and cost-effectiveness at 1- and 2-years.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
2000
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
MI
-
Milan, MI, Włochy, 20138
- Centro Cardiologico Monzino IRCCS
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Opis
Inclusion Criteria:
- Consecutive patients (age ≥ 18 years) with known or suspected CAD referred for clinically indicated diagnostic evaluation.
- CCTA has to be performed with the state of art in terms of scanner technology as follow: Revolution CT (GE Healthcare, Milwaukee, WI), CardioGraphe (Arineta, Caesarea, Israel), SOMATOM Force (Siemens, Forchheim, Germany), Brilliance iCT and IQon CT (Philips, Best, Netherlands), Aquilion One Vision (Toshiba Medical Systems Corp., Otawara, Japan).
Exclusion Criteria:
- Performance of any non-invasive diagnostic testing within 90 days before enrollment
- Low to intermediate pre-test likelihood of CAD according to the updated Diamond-Forrester risk model score
- Acute coronary syndrome
- Need for an emergent procedure
- Evidence of clinical instability
- Contra-indication to contrast agent administration and/or impaired renal function
- Inability to sustain a breath hold
- Pregnancy
- Cardiac arrhythmias
- Presence of pace maker or implantable cardioverter defibrillator
- Contra-indications to the administration of sub-lingual nitrates, beta-blockade and adenosine
- Structural cardiomyopathy outside of suspected or know ischemic heart disease
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: CCTA Strategy
CCTA will be performed with one of the latest generation scanners.
A stenosis > 50% will be considered as significant from an anatomical point of view.
For coronary stents, degree of intrastent restenosis will be evaluated by visual assessment of intraluminal contrast density.
ISR > 50% will be considered as significant from an anatomical point of view.
For CABG, each graft will be visually evaluated and scored as patent, non-significant stenosis ≤ 50%, significant stenosis > 50%, or occluded.
For patients with positive CCTA results, additional stress CTP will be performed subsequently.
If indicated, vasodilatation will be induced with i.v.
adenosine injection or regadenoson.
Static or dynamic CTP will be performed according to local practice and scanner technology available.
For all patients with previous history of MI the presence of reversible ischemia will be obtained by the comparison between rest and stress perfusion.
|
When judged indicated, functional assessment with stress CTP perfusion will be performed on top of CCTA.
|
|
Aktywny komparator: Standard of care Strategy
Patients randomized to this group will be evaluated according to current clinical guidelines with the following approaches: (a) stress ECG, or imaging-based tests such as Stress Echo, Stress CMR, SPECT or PET; (b) direct referral to ICA.
|
(a) functional non-invasive tests (stress ECG, or imaging-based tests such as Stress Echo, Stress CMR, SPECT or PET) as a gatekeeper for ICA; (b) direct referral to ICA.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Reclassification rate of CCTA in group B due to the addition of CTP
Ramy czasowe: 30 days.
|
For each enrolled patient in whom both CCTA and stress CTP will be performed, the endpoint review committee will use data from coronary CTA and CTP, along with the clinical data to determine the management plan using the following criteria: (a) optimal medical therapy, (b) more non-invasive information required, (c) invasive evaluation required, (d) revascularization treatment (PCI or CABG or hybrid treatment).
|
30 days.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Downstream non-invasive testing
Ramy czasowe: 1- and 2-years.
|
Comparison between group A and group B in terms of number of non-invasive downstream testing (Exercise EKG, Stress-Echo, SPECT, Stress CMR, PET) or invasive testing (invasive coronary angiography) performed after the randomization.
|
1- and 2-years.
|
|
Downstream invasive testing
Ramy czasowe: 1- and 2-years.
|
Comparison between group A and group B in terms of number of downstream invasive testing (invasive coronary angiography) performed after the randomization.
|
1- and 2-years.
|
|
Prevalence of obstructive CAD at ICA
Ramy czasowe: 1- and 2-years.
|
Comparison between group A and group B in terms of number of patients with obstructive CAD at ICA.
|
1- and 2-years.
|
|
Revascularization
Ramy czasowe: 1- and 2-years.
|
Comparison between group A and group B in terms of number of patients treated with revascularization (PCI or CABG or hybrid treatment).
|
1- and 2-years.
|
|
Effective Dose
Ramy czasowe: 1- and 2-years.
|
Comparison between group A and group B in terms of cumulative Effective Dose (ED), measured in mSv, due to non-invasive or invasive testing performed after randomization.
|
1- and 2-years.
|
|
Overall costs related to downstream diagnostic tests.
Ramy czasowe: 1- and 2-years.
|
Comparison between group A and group B in terms of overall costs of downstream diagnostic tests (sum of costs of all diagnostic tests performed after randomization), expressed in Dollars, according to local reimbursement.
|
1- and 2-years.
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Hospitalization for cardiac reason
Ramy czasowe: 1- and 2-years.
|
Comparison between group A and group B group in terms of number of patients that needed hospitalization for cardiac reason.
|
1- and 2-years.
|
|
Unstable angina
Ramy czasowe: 1- and 2-years.
|
Comparison between group A and group B group in terms of number of patients that needed hospitalization for unstable angina (defined according to 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation.
Eur Heart J 2016:37,267-315).
|
1- and 2-years.
|
|
Non-fatal myocardial infarction
Ramy czasowe: 1- and 2-years.
|
Comparison between group A and group B group in terms of number of patients that experienced non-fatal myocardial infarction (defined according to Fourth universal definition of myocardial infarction, 2018.
Eur Heart J 2019:40,237-269).
|
1- and 2-years.
|
|
Cardiac death
Ramy czasowe: 1- and 2-years.
|
Comparison between group A and group B group in terms of number of patients that experienced death because of immediate cardiac cause (e.g., MI, low-output failure, fatal arrhythmia) or vascular cause (e.g., cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause).
Unwitnessed death and death of unknown cause will be classified as cardiovascular death.
|
1- and 2-years.
|
|
MACE (Major adverse cardiovascular events)
Ramy czasowe: 1- and 2-years.
|
MACE will be defined as a combined endpoint of unstable angina, nonfatal MI, and cardiac death.
|
1- and 2-years.
|
|
Cost-effectiveness ratio
Ramy czasowe: 1- and 2-years.
|
Cost-effectiveness ratio will be calculated according to the following equation: (Index test cost + downstream diagnostic tests cost) / projected remaining life expectancy.
|
1- and 2-years.
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Gianluca Pontone, MD, PhD, Centro Cardiologico Monzino, IRCCS
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- Austen WG, Edwards JE, Frye RL, Gensini GG, Gott VL, Griffith LS, McGoon DC, Murphy ML, Roe BB. A reporting system on patients evaluated for coronary artery disease. Report of the Ad Hoc Committee for Grading of Coronary Artery Disease, Council on Cardiovascular Surgery, American Heart Association. Circulation. 1975 Apr;51(4 Suppl):5-40. doi: 10.1161/01.cir.51.4.5. No abstract available.
- Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available.
- Budoff MJ, Dowe D, Jollis JG, Gitter M, Sutherland J, Halamert E, Scherer M, Bellinger R, Martin A, Benton R, Delago A, Min JK. Diagnostic performance of 64-multidetector row coronary computed tomographic angiography for evaluation of coronary artery stenosis in individuals without known coronary artery disease: results from the prospective multicenter ACCURACY (Assessment by Coronary Computed Tomographic Angiography of Individuals Undergoing Invasive Coronary Angiography) trial. J Am Coll Cardiol. 2008 Nov 18;52(21):1724-32. doi: 10.1016/j.jacc.2008.07.031.
- Einstein AJ, Moser KW, Thompson RC, Cerqueira MD, Henzlova MJ. Radiation dose to patients from cardiac diagnostic imaging. Circulation. 2007 Sep 11;116(11):1290-305. doi: 10.1161/CIRCULATIONAHA.107.688101. No abstract available.
- Leipsic J, Abbara S, Achenbach S, Cury R, Earls JP, Mancini GJ, Nieman K, Pontone G, Raff GL. SCCT guidelines for the interpretation and reporting of coronary CT angiography: a report of the Society of Cardiovascular Computed Tomography Guidelines Committee. J Cardiovasc Comput Tomogr. 2014 Sep-Oct;8(5):342-58. doi: 10.1016/j.jcct.2014.07.003. Epub 2014 Jul 24. No abstract available.
- Takx RA, Blomberg BA, El Aidi H, Habets J, de Jong PA, Nagel E, Hoffmann U, Leiner T. Diagnostic accuracy of stress myocardial perfusion imaging compared to invasive coronary angiography with fractional flow reserve meta-analysis. Circ Cardiovasc Imaging. 2015 Jan;8(1):e002666. doi: 10.1161/CIRCIMAGING.114.002666.
- Cerci RJ, Arbab-Zadeh A, George RT, Miller JM, Vavere AL, Mehra V, Yoneyama K, Texter J, Foster C, Guo W, Cox C, Brinker J, Di Carli M, Lima JA. Aligning coronary anatomy and myocardial perfusion territories: an algorithm for the CORE320 multicenter study. Circ Cardiovasc Imaging. 2012 Sep 1;5(5):587-95. doi: 10.1161/CIRCIMAGING.111.970608. Epub 2012 Aug 10.
- Shaw LJ, Berman DS, Maron DJ, Mancini GB, Hayes SW, Hartigan PM, Weintraub WS, O'Rourke RA, Dada M, Spertus JA, Chaitman BR, Friedman J, Slomka P, Heller GV, Germano G, Gosselin G, Berger P, Kostuk WJ, Schwartz RG, Knudtson M, Veledar E, Bates ER, McCallister B, Teo KK, Boden WE; COURAGE Investigators. Optimal medical therapy with or without percutaneous coronary intervention to reduce ischemic burden: results from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial nuclear substudy. Circulation. 2008 Mar 11;117(10):1283-91. doi: 10.1161/CIRCULATIONAHA.107.743963. Epub 2008 Feb 11.
- Pijls NH, Fearon WF, Tonino PA, Siebert U, Ikeno F, Bornschein B, van't Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, De Bruyne B; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention in patients with multivessel coronary artery disease: 2-year follow-up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study. J Am Coll Cardiol. 2010 Jul 13;56(3):177-84. doi: 10.1016/j.jacc.2010.04.012. Epub 2010 May 28.
- Pontone G, Muscogiuri G, Baggiano A, Andreini D, Guaricci AI, Guglielmo M, Fazzari F, Mushtaq S, Conte E, Annoni A, Formenti A, Mancini E, Verdecchia M, Fusini L, Bonfanti L, Consiglio E, Rabbat MG, Bartorelli AL, Pepi M. Image Quality, Overall Evaluability, and Effective Radiation Dose of Coronary Computed Tomography Angiography With Prospective Electrocardiographic Triggering Plus Intracycle Motion Correction Algorithm in Patients With a Heart Rate Over 65 Beats Per Minute. J Thorac Imaging. 2018 Jul;33(4):225-231. doi: 10.1097/RTI.0000000000000320.
- Erthal F, Premaratne M, Yam Y, Chen L, Lamba J, Keenan M, Haddad T, Pharasi K, Anand S, Beanlands RS, Burwash IG, Dwivedi G, Ruddy TD, Chow BJW. Appropriate Use Criteria for Cardiac Computed Tomography: Does Computed Tomography Have Incremental Value in All Appropriate Use Criteria Categories? J Thorac Imaging. 2018 Mar;33(2):132-137. doi: 10.1097/RTI.0000000000000297.
- Pontone G, Bertella E, Mushtaq S, Loguercio M, Cortinovis S, Baggiano A, Conte E, Annoni A, Formenti A, Beltrama V, Guaricci AI, Andreini D. Coronary artery disease: diagnostic accuracy of CT coronary angiography--a comparison of high and standard spatial resolution scanning. Radiology. 2014 Jun;271(3):688-94. doi: 10.1148/radiol.13130909. Epub 2014 Feb 8.
- Pontone G, Andreini D, Bartorelli AL, Bertella E, Cortinovis S, Mushtaq S, Foti C, Annoni A, Formenti A, Baggiano A, Conte E, Bovis F, Veglia F, Ballerini G, Fiorentini C, Agostoni P, Pepi M. A long-term prognostic value of CT angiography and exercise ECG in patients with suspected CAD. JACC Cardiovasc Imaging. 2013 Jun;6(6):641-50. doi: 10.1016/j.jcmg.2013.01.015.
- Pontone G, Andreini D, Guaricci AI, Rota C, Guglielmo M, Mushtaq S, Baggiano A, Beltrama V, Fusini L, Solbiati A, Segurini C, Conte E, Gripari P, Annoni A, Formenti A, Petulla' M, Lombardi F, Muscogiuri G, Bartorelli AL, Pepi M. The STRATEGY Study (Stress Cardiac Magnetic Resonance Versus Computed Tomography Coronary Angiography for the Management of Symptomatic Revascularized Patients): Resources and Outcomes Impact. Circ Cardiovasc Imaging. 2016 Oct;9(10):e005171. doi: 10.1161/CIRCIMAGING.116.005171.
- 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.
- Yang Z, Zheng H, Zhou T, Yang LF, Hu XF, Peng ZH, Jiang YZ, Li M, Sun G. Diagnostic performance of myocardial perfusion imaging with SPECT, CT and MR compared to fractional flow reserve as reference standard. Int J Cardiol. 2015;190:103-5. doi: 10.1016/j.ijcard.2015.04.091. Epub 2015 Apr 15. No abstract available.
- Pontone G, Andreini D, Guaricci AI, Baggiano A, Fazzari F, Guglielmo M, Muscogiuri G, Berzovini CM, Pasquini A, Mushtaq S, Conte E, Calligaris G, De Martini S, Ferrari C, Galli S, Grancini L, Ravagnani P, Teruzzi G, Trabattoni D, Fabbiocchi F, Lualdi A, Montorsi P, Rabbat MG, Bartorelli AL, Pepi M. Incremental Diagnostic Value of Stress Computed Tomography Myocardial Perfusion With Whole-Heart Coverage CT Scanner in Intermediate- to High-Risk Symptomatic Patients Suspected of Coronary Artery Disease. JACC Cardiovasc Imaging. 2019 Feb;12(2):338-349. doi: 10.1016/j.jcmg.2017.10.025. Epub 2018 Feb 14.
- Pontone G, Andreini D, Guaricci AI, Guglielmo M, Baggiano A, Muscogiuri G, Fusini L, Soldi M, Fazzari F, Berzovini C, Pasquini A, Ciancarella P, Mushtaq S, Conte E, Calligaris G, De Martini S, Ferrari C, Galli S, Grancini L, Ravagnani P, Teruzzi G, Trabattoni D, Fabbiocchi F, Lualdi A, Montorsi P, Rabbat MG, Bartorelli AL, Pepi M. Quantitative vs. qualitative evaluation of static stress computed tomography perfusion to detect haemodynamically significant coronary artery disease. Eur Heart J Cardiovasc Imaging. 2018 Nov 1;19(11):1244-1252. doi: 10.1093/ehjci/jey111.
- Jensen JM, Voss M, Hansen VB, Andersen LK, Johansen PB, Munkholm H, Norgaard BL. Risk stratification of patients suspected of coronary artery disease: comparison of five different models. Atherosclerosis. 2012 Feb;220(2):557-62. doi: 10.1016/j.atherosclerosis.2011.11.027. Epub 2011 Nov 25.
- Pontone G, Andreini D, Bertella E, Baggiano A, Mushtaq S, Loguercio M, Segurini C, Conte E, Beltrama V, Annoni A, Formenti A, Petulla M, Guaricci AI, Montorsi P, Trabattoni D, Bartorelli AL, Pepi M. Impact of an intra-cycle motion correction algorithm on overall evaluability and diagnostic accuracy of computed tomography coronary angiography. Eur Radiol. 2016 Jan;26(1):147-56. doi: 10.1007/s00330-015-3793-1. Epub 2015 May 9.
- Andreini D, Pontone G, Bartorelli AL, Trabattoni D, Mushtaq S, Bertella E, Annoni A, Formenti A, Cortinovis S, Montorsi P, Veglia F, Ballerini G, Pepi M. Comparison of feasibility and diagnostic accuracy of 64-slice multidetector computed tomographic coronary angiography versus invasive coronary angiography versus intravascular ultrasound for evaluation of in-stent restenosis. Am J Cardiol. 2009 May 15;103(10):1349-58. doi: 10.1016/j.amjcard.2009.01.343. Epub 2009 Mar 25.
- Cury RC, Magalhaes TA, Paladino AT, Shiozaki AA, Perini M, Senra T, Lemos PA, Cury RC, Rochitte CE. Dipyridamole stress and rest transmural myocardial perfusion ratio evaluation by 64 detector-row computed tomography. J Cardiovasc Comput Tomogr. 2011 Nov-Dec;5(6):443-8. doi: 10.1016/j.jcct.2011.10.012. Epub 2011 Nov 4.
- Feuchtner G, Goetti R, Plass A, Wieser M, Scheffel H, Wyss C, Stolzmann P, Donati O, Schnabl J, Falk V, Alkadhi H, Leschka S, Cury RC. Adenosine stress high-pitch 128-slice dual-source myocardial computed tomography perfusion for imaging of reversible myocardial ischemia: comparison with magnetic resonance imaging. Circ Cardiovasc Imaging. 2011 Sep;4(5):540-9. doi: 10.1161/CIRCIMAGING.110.961250. Epub 2011 Aug 23.
- Moschetti K, Favre D, Pinget C, Pilz G, Petersen SE, Wagner A, Wasserfallen JB, Schwitter JJ. Comparative cost-effectiveness analyses of cardiovascular magnetic resonance and coronary angiography combined with fractional flow reserve for the diagnosis of coronary artery disease. J Cardiovasc Magn Reson. 2014 Jan 25;16(1):13. doi: 10.1186/1532-429X-16-13.
- Turchetti G, Lorenzoni V, Bellelli S, Pierotti F, Rovai D, Caselli C, Underwood R, Knuuti J, Neglia D. Effectiveness And Costs Of Different Strategies For The Diagnosis Of Stable Coronary Artery Disease Results From The Evinci Study. Value Health. 2014 Nov;17(7):A474. doi: 10.1016/j.jval.2014.08.1352. Epub 2014 Oct 26. No abstract available.
- Hlatky MA, Shilane D, Hachamovitch R, Dicarli MF; SPARC Investigators. Economic outcomes in the Study of Myocardial Perfusion and Coronary Anatomy Imaging Roles in Coronary Artery Disease registry: the SPARC Study. J Am Coll Cardiol. 2014 Mar 18;63(10):1002-8. doi: 10.1016/j.jacc.2013.11.038.
- Lubbers M, Coenen A, Kofflard M, Bruning T, Kietselaer B, Galema T, Kock M, Niezen A, Das M, van Gent M, van den Bos EJ, van Woerkens L, Musters P, Kooij S, Nous F, Budde R, Hunink M, Nieman K. Comprehensive Cardiac CT With Myocardial Perfusion Imaging Versus Functional Testing in Suspected Coronary Artery Disease: The Multicenter, Randomized CRESCENT-II Trial. JACC Cardiovasc Imaging. 2018 Nov;11(11):1625-1636. doi: 10.1016/j.jcmg.2017.10.010. Epub 2017 Dec 13.
- American College of Cardiology Foundation Task Force on Expert Consensus Documents; Mark DB, Berman DS, Budoff MJ, Carr JJ, Gerber TC, Hecht HS, Hlatky MA, Hodgson JM, Lauer MS, Miller JM, Morin RL, Mukherjee D, Poon M, Rubin GD, Schwartz RS. ACCF/ACR/AHA/NASCI/SAIP/SCAI/SCCT 2010 expert consensus document on coronary computed tomographic angiography: a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents. Circulation. 2010 Jun 8;121(22):2509-43. doi: 10.1161/CIR.0b013e3181d4b618. Epub 2010 May 17. No abstract available.
- Min JK, Dunning A, Lin FY, Achenbach S, Al-Mallah M, Budoff MJ, Cademartiri F, Callister TQ, Chang HJ, Cheng V, Chinnaiyan K, Chow BJ, Delago A, Hadamitzky M, Hausleiter J, Kaufmann P, Maffei E, Raff G, Shaw LJ, Villines T, Berman DS; CONFIRM Investigators. Age- and sex-related differences in all-cause mortality risk based on coronary computed tomography angiography findings results from the International Multicenter CONFIRM (Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter Registry) of 23,854 patients without known coronary artery disease. J Am Coll Cardiol. 2011 Aug 16;58(8):849-60. doi: 10.1016/j.jacc.2011.02.074.
- Pontone G, Andreini D, Bartorelli AL, Cortinovis S, Mushtaq S, Bertella E, Annoni A, Formenti A, Nobili E, Trabattoni D, Montorsi P, Ballerini G, Agostoni P, Pepi M. Diagnostic accuracy of coronary computed tomography angiography: a comparison between prospective and retrospective electrocardiogram triggering. J Am Coll Cardiol. 2009 Jul 21;54(4):346-55. doi: 10.1016/j.jacc.2009.04.027.
- Douglas PS, Hoffmann U. Anatomical versus Functional Testing for Coronary Artery Disease. N Engl J Med. 2015 Jul 2;373(1):91. doi: 10.1056/NEJMc1505594. No abstract available.
- Mudrick D, Kaltenbach LA, Shah B, Lytle B, Masoudi FA, Mark DB, Federspiel JJ, Cowper PA, Green C, Douglas PS. Downstream testing and subsequent procedures after coronary computed tomographic angiography following coronary stenting in patients >/=65 years of age. Am J Cardiol. 2012 Sep 15;110(6):776-83. doi: 10.1016/j.amjcard.2012.05.004. Epub 2012 May 30.
- Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; ESC Scientific Document Group. Fourth universal definition of myocardial infarction (2018). Eur Heart J. 2019 Jan 14;40(3):237-269. doi: 10.1093/eurheartj/ehy462. No abstract available.
- Task Force Members; Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A, Bugiardini R, Crea F, Cuisset T, Di Mario C, Ferreira JR, Gersh BJ, Gitt AK, Hulot JS, Marx N, Opie LH, Pfisterer M, Prescott E, Ruschitzka F, Sabate M, Senior R, Taggart DP, van der Wall EE, Vrints CJ; ESC Committee for Practice Guidelines; Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Knuuti J, Valgimigli M, Bueno H, Claeys MJ, Donner-Banzhoff N, Erol C, Frank H, Funck-Brentano C, Gaemperli O, Gonzalez-Juanatey JR, Hamilos M, Hasdai D, Husted S, James SK, Kervinen K, Kolh P, Kristensen SD, Lancellotti P, Maggioni AP, Piepoli MF, Pries AR, Romeo F, Ryden L, Simoons ML, Sirnes PA, Steg PG, Timmis A, Wijns W, Windecker S, Yildirir A, Zamorano JL. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013 Oct;34(38):2949-3003. doi: 10.1093/eurheartj/eht296. Epub 2013 Aug 30. No abstract available.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 lipca 2019
Zakończenie podstawowe (Szacowany)
30 czerwca 2026
Ukończenie studiów (Szacowany)
30 czerwca 2027
Daty rejestracji na studia
Pierwszy przesłany
30 maja 2019
Pierwszy przesłany, który spełnia kryteria kontroli jakości
4 czerwca 2019
Pierwszy wysłany (Rzeczywisty)
6 czerwca 2019
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
3 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
1 czerwca 2026
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- R993/19-CCM 1044
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .