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Computed tomography versus invasive coronary angiography: design and methods of the pragmatic randomised multicentre DISCHARGE trial
AE. Napp, R. Haase, M. Laule, GM. Schuetz, M. Rief, H. Dreger, G. Feuchtner, G. Friedrich, M. Špaček, V. Suchánek, K. Fuglsang Kofoed, T. Engstroem, S. Schroeder, T. Drosch, M. Gutberlet, M. Woinke, P. Maurovich-Horvat, B. Merkely, P. Donnelly,...
Language English Country Germany
Document type Journal Article, Multicenter Study, Randomized Controlled Trial
NLK
ProQuest Central
from 1997-01-01 to 2017-12-31
CINAHL Plus with Full Text (EBSCOhost)
from 2008-01-01 to 1 year ago
Medline Complete (EBSCOhost)
from 2000-01-01 to 1 year ago
Nursing & Allied Health Database (ProQuest)
from 1997-01-01 to 2017-12-31
Health & Medicine (ProQuest)
from 1997-01-01 to 2017-12-31
- MeSH
- Cost-Benefit Analysis MeSH
- Outcome Assessment, Health Care * MeSH
- Coronary Angiography methods MeSH
- Quality of Life MeSH
- Middle Aged MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Coronary Artery Disease diagnosis economics MeSH
- Pilot Projects MeSH
- Tomography, X-Ray Computed methods MeSH
- Retrospective Studies MeSH
- Aged MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Geographicals
- Europe MeSH
OBJECTIVES: More than 3.5 million invasive coronary angiographies (ICA) are performed in Europe annually. Approximately 2 million of these invasive procedures might be reduced by noninvasive tests because no coronary intervention is performed. Computed tomography (CT) is the most accurate noninvasive test for detection and exclusion of coronary artery disease (CAD). To investigate the comparative effectiveness of CT and ICA, we designed the European pragmatic multicentre DISCHARGE trial funded by the 7th Framework Programme of the European Union (EC-GA 603266). METHODS: In this trial, patients with a low-to-intermediate pretest probability (10-60 %) of suspected CAD and a clinical indication for ICA because of stable chest pain will be randomised in a 1-to-1 ratio to CT or ICA. CT and ICA findings guide subsequent management decisions by the local heart teams according to current evidence and European guidelines. RESULTS: Major adverse cardiovascular events (MACE) defined as cardiovascular death, myocardial infarction and stroke as a composite endpoint will be the primary outcome measure. Secondary and other outcomes include cost-effectiveness, radiation exposure, health-related quality of life (HRQoL), socioeconomic status, lifestyle, adverse events related to CT/ICA, and gender differences. CONCLUSIONS: The DISCHARGE trial will assess the comparative effectiveness of CT and ICA. KEY POINTS: • Coronary artery disease (CAD) is a major cause of morbidity and mortality. • Invasive coronary angiography (ICA) is the reference standard for detection of CAD. • Noninvasive computed tomography angiography excludes CAD with high sensitivity. • CT may effectively reduce the approximately 2 million negative ICAs in Europe. • DISCHARGE addresses this hypothesis in patients with low-to-intermediate pretest probability for CAD.
Basque Office for Health Technology Assessment Donostia San Sebastian 1 01010 Vitoria Gasteiz Spain
Department of Cardiology Aintree University Hospital Longmoor Lane L9 7AL Liverpool UK
Department of Cardiology ALB FILS KLINIKEN GmbH Eichertstrasse 3 73035 Goeppingen Germany
Department of Cardiology Azienda Ospedaliera Brotzu Cagliari CA Italy
Department of Cardiology Basurto University Hospital Avenida Montevideo 18 48013 Bilbao Spain
Department of Cardiology Cardio Med Medical Center 22 decembrie 1989 540156 Targu Mures Romania
Department of Cardiology Charité Universitätsmedizin Berlin Charitéplatz 1 10117 Berlin Germany
Department of Cardiology Clinical Hospital Center Zemun Vukova 9 11080 Belgrade Zemun Serbia
Department of Cardiology Lithuanian University of Health Sciences Eivelniu 2 50009 Kaunas Lithuania
Department of Cardiology Medical University Innsbruck Anichstr 35 6020 Innsbruck Austria
Department of Cardiology Rigshospitalet Region Hovedstaden Rigshospitalet 9 2100 Copenhagen Denmark
Department of Cardiology St Vincent's University Hospital Belfield Campus 4 Dublin Ireland
Department of Cardiology The Institute of Cardiology in Warsaw Ul Alpejska 42 04 628 Warsaw Poland
Department of Cardiology University Hospital Motol Vuvalu 84 150 06 Prague 5 Czech Republic
Department of Radiology Aintree University Hospital Longmoor Lane L9 7AL Liverpool UK
Department of Radiology Basurto University Hospital Avenida Montevideo 18 48013 Bilbao Spain
Department of Radiology Charité Universitätsmedizin Berlin Charitéplatz 1 10117 Berlin Germany
Department of Radiology Leiden University Medical Center Albinusdreef 2 2333 ZA Leiden Netherlands
Department of Radiology Lithuanian University of Health Sciences Eivelniu 2 50009 Kaunas Lithuania
Department of Radiology Medical University Innsbruck Anichstr 35 6020 Innsbruck Austria
Department of Radiology Sapienza University of Rome Viale Regina Elena 324 00161 Rome Italy
Department of Radiology The Institute of Cardiology in Warsaw Ul Alpejska 42 04 628 Warsaw Poland
Department of Radiology University Hospital Motol Vuvalu 84 150 06 Prague 5 Czech Republic
Department of Radiology University of Leipzig Heart Centre Strümpellstrasse 39 04289 Leipzig Germany
European Clinical Research Infrastructure Network Management Office 5 Rue Watt 75013 Paris France
Heart Centre Turku University Hospital Kiinamyllynkatu 4 8 FI 20120 Turku Finland
Institute of Public Health Charité Universitätsmedizin Berlin Charitéplatz 1 10117 Berlin Germany
References provided by Crossref.org
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- $a Napp, Adriane E $u Department of Radiology, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany.
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- $a Computed tomography versus invasive coronary angiography: design and methods of the pragmatic randomised multicentre DISCHARGE trial / $c AE. Napp, R. Haase, M. Laule, GM. Schuetz, M. Rief, H. Dreger, G. Feuchtner, G. Friedrich, M. Špaček, V. Suchánek, K. Fuglsang Kofoed, T. Engstroem, S. Schroeder, T. Drosch, M. Gutberlet, M. Woinke, P. Maurovich-Horvat, B. Merkely, P. Donnelly, P. Ball, JD. Dodd, M. Quinn, L. Saba, M. Porcu, M. Francone, M. Mancone, A. Erglis, L. Zvaigzne, A. Jankauskas, G. Sakalyte, T. Harań, M. Ilnicka-Suckiel, N. Bettencourt, V. Gama-Ribeiro, S. Condrea, I. Benedek, N. Čemerlić Adjić, O. Adjić, J. Rodriguez-Palomares, B. Garcia Del Blanco, G. Roditi, C. Berry, G. Davis, E. Thwaite, J. Knuuti, M. Pietilä, C. Kępka, M. Kruk, R. Vidakovic, AN. Neskovic, I. Díez, I. Lecumberri, J. Geleijns, C. Kubiak, A. Strenge-Hesse, TH. Do, F. Frömel, I. Gutiérrez-Ibarluzea, G. Benguria-Arrate, H. Keiding, C. Katzer, J. Müller-Nordhorn, N. Rieckmann, M. Walther, P. Schlattmann, M. Dewey, . ,
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- $a OBJECTIVES: More than 3.5 million invasive coronary angiographies (ICA) are performed in Europe annually. Approximately 2 million of these invasive procedures might be reduced by noninvasive tests because no coronary intervention is performed. Computed tomography (CT) is the most accurate noninvasive test for detection and exclusion of coronary artery disease (CAD). To investigate the comparative effectiveness of CT and ICA, we designed the European pragmatic multicentre DISCHARGE trial funded by the 7th Framework Programme of the European Union (EC-GA 603266). METHODS: In this trial, patients with a low-to-intermediate pretest probability (10-60 %) of suspected CAD and a clinical indication for ICA because of stable chest pain will be randomised in a 1-to-1 ratio to CT or ICA. CT and ICA findings guide subsequent management decisions by the local heart teams according to current evidence and European guidelines. RESULTS: Major adverse cardiovascular events (MACE) defined as cardiovascular death, myocardial infarction and stroke as a composite endpoint will be the primary outcome measure. Secondary and other outcomes include cost-effectiveness, radiation exposure, health-related quality of life (HRQoL), socioeconomic status, lifestyle, adverse events related to CT/ICA, and gender differences. CONCLUSIONS: The DISCHARGE trial will assess the comparative effectiveness of CT and ICA. KEY POINTS: • Coronary artery disease (CAD) is a major cause of morbidity and mortality. • Invasive coronary angiography (ICA) is the reference standard for detection of CAD. • Noninvasive computed tomography angiography excludes CAD with high sensitivity. • CT may effectively reduce the approximately 2 million negative ICAs in Europe. • DISCHARGE addresses this hypothesis in patients with low-to-intermediate pretest probability for CAD.
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