NCT02400229

Brief Summary

The primary hypothesis is that computed tomography (CT) is superior to invasive coronary angiography (ICA) concerning the primary endpoint MACE (MACE = major adverse cardiovascular event; defined as at least one of the following: cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke) after a maximum follow-up of 4 years, in other words, that CT will result in a significantly lower rate of MACE. Secondary outcomes include MICE (MICE = minor cardiovascular events), procedural complications, cost-effectiveness, radiation exposure, cross-over to CT or ICA, gender differences, and health-related quality of life.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,546

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
15 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

October 3, 2015

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

6.4 years

First QC Date

January 15, 2015

Last Update Submit

February 11, 2025

Conditions

Coronary Artery Disease

Keywords

coronary artery diseasestable chest painintermediate pretest probabilitypragmatic randomised controlled trialcoronary computed tomographyangiographyinvasive coronary angiography

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiovascular Event

    Composite endpoint: major adverse cardiovascular event (MACE); defined as at least one of the following: cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.

    1 minute after randomisation to CT/ICA diagnostic procedure and during follow-up

Secondary Outcomes (127)

  • Likelihood of receiving coronary intervention in different European countries

    at baseline, 1-year follow-up and final follow-up up to a max of 4 years

  • Rates of percutaneous coronary intervention and use of intracoronary techniques different European countries

    at baseline, 1-year follow-up and final follow-up up to a max of 4 years

  • Patient management in different European countries

    at baseline, 1-year follow-up and final follow-up up to a max of 4 years

  • Follow-up strategies in different European countries

    at baseline, 1-year follow-up and final follow-up up to a max of 4 years

  • European differences in occurrence and extent of Coronary Artery Disease in regards to city versus rural lifestyle

    at baseline, 1-year follow-up and final follow-up up to a max of 4 years

  • +122 more secondary outcomes

Study Arms (2)

Computed Tomography Angiography (CTA)

EXPERIMENTAL

Computed Tomography Angiography including coronary calcium scoring and coronary computed tomography angiography

Procedure: Computed tomography angiography (cardiac CT)

Invasive coronary angiography (ICA)

ACTIVE COMPARATOR

Invasive coronary angiography

Procedure: Invasive coronary angiography (ICA)

Interventions

Computed tomography angiography (cardiac CT)PROCEDURE

Clinical management/treatment decisions based on cardiac computed tomography including coronary calcium scoring and coronary computed tomography angiography

Computed Tomography Angiography (CTA)
Invasive coronary angiography (ICA)PROCEDURE

Clinical management/treatment decisions based on invasive coronary angiography

Invasive coronary angiography (ICA)

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with suspected coronary artery disease with stable chest pain and intermediate pretest probability (10-60%) of CAD referred for conventional coronary angiography.
  • "Stable chest pain" defined as not:
  • being acute (= first appearance within the last 48 hours) or
  • instable (= a) first appearance with at least Canadian Cardiovascular Society Angina Grading Scale (CCS) Class III, b) progredient with at least 1 CCS Class to at least CCS Class III or, now at rest for at least 20 min) angina pectoris
  • Patients at least 30 years of age
  • Written informed consent

You may not qualify if:

  • Patients on hemodialysis
  • No sinus rhythm
  • Pregnancy
  • Any medical condition that leads to the concern that participation is not in the best interest of health (e.g., extensive comorbidities)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Medizinische Universitaet Innsbruck

Innsbruck, 6020, Austria

Location

Fakultni Nemocnice V Motole

Prague, 15006, Czechia

Location

Region Hovedstaden

Copenhagen, 3400, Denmark

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Alb Fils Kliniken Gmbh

Göppingen, 73035, Germany

Location

Universitaet Leipzig

Leipzig, 04109, Germany

Location

Semmelweis Egyetem

Budapest, 1085, Hungary

Location

University College Dublin, National University of Ireland

Dublin, 4, Ireland

Location

Universita Degli Studi Di Cagliari

Cagliari, 09124, Italy

Location

Universita Degli Studi Di Roma La Sapienza

Rome, 00185, Italy

Location

Paula Stradina Kliniska Universitates Slimnica As

Riga, 1002, Latvia

Location

Lietuvos Sveikatos Mokslu Universitetas

Kaunas, 44307, Lithuania

Location

Wojewodzki Szpital Specjalistyczny We Wroclawiu

Wroclaw, 51124, Poland

Location

Centro Hospitalar de Vila Nova de Gaia/Espinho Epe

Vila Nova de Gaia, 4434502, Portugal

Location

Cardio Med Srl

Târgu Mureş, 540124, Romania

Location

Institut Za Kardiovaskularne Bolesti Vojvodine

Novi Sad, 21204, Serbia

Location

Institut Catala de La Salut

Barcelona, 08007, Spain

Location

South Eastern Health and Social Care Trust Nhs

Belfast, BT16 1RH, United Kingdom

Location

University of Glasgow

Glasgow, G12 8QQ, United Kingdom

Location

Aintree University Hospital Nhs Foundation Trust

Liverpool, L9 7AL, United Kingdom

Location

Related Publications (12)

  • Napp AE, Haase R, Laule M, Schuetz GM, Rief M, Dreger H, Feuchtner G, Friedrich G, Spacek M, Suchanek V, Fuglsang Kofoed K, Engstroem T, Schroeder S, Drosch T, Gutberlet M, Woinke M, Maurovich-Horvat P, Merkely B, Donnelly P, Ball P, Dodd JD, Quinn M, Saba L, Porcu M, Francone M, Mancone M, Erglis A, Zvaigzne L, Jankauskas A, Sakalyte G, Haran T, Ilnicka-Suckiel M, Bettencourt N, Gama-Ribeiro V, Condrea S, Benedek I, Cemerlic Adjic N, Adjic O, Rodriguez-Palomares J, Garcia Del Blanco B, Roditi G, Berry C, Davis G, Thwaite E, Knuuti J, Pietila M, Kepka C, Kruk M, Vidakovic R, Neskovic AN, Diez I, Lecumberri I, Geleijns J, Kubiak C, Strenge-Hesse A, Do TH, Fromel F, Gutierrez-Ibarluzea I, Benguria-Arrate G, Keiding H, Katzer C, Muller-Nordhorn J, Rieckmann N, Walther M, Schlattmann P, Dewey M; DISCHARGE Trial Group. Computed tomography versus invasive coronary angiography: design and methods of the pragmatic randomised multicentre DISCHARGE trial. Eur Radiol. 2017 Jul;27(7):2957-2968. doi: 10.1007/s00330-016-4620-z. Epub 2016 Nov 18.

    PMID: 27864607BACKGROUND

  • Dewey M, Rief M, Martus P, Kendziora B, Feger S, Dreger H, Priem S, Knebel F, Bohm M, Schlattmann P, Hamm B, Schonenberger E, Laule M, Zimmermann E. Evaluation of computed tomography in patients with atypical angina or chest pain clinically referred for invasive coronary angiography: randomised controlled trial. BMJ. 2016 Oct 24;355:i5441. doi: 10.1136/bmj.i5441.

    PMID: 27777234BACKGROUND

  • Haase R, Dodd JD, Kauczor HU, Kazerooni EA, Dewey M. Developing a lung nodule management protocol specifically for cardiac CT: Methodology in the DISCHARGE trial. Eur J Radiol Open. 2020 Jun 25;7:100235. doi: 10.1016/j.ejro.2020.100235. eCollection 2020.

    PMID: 32637465BACKGROUND

  • De Rubeis G, Napp AE, Schlattmann P, Geleijns J, Laule M, Dreger H, Kofoed K, Sorgaard M, Engstrom T, Tilsted HH, Boi A, Porcu M, Cossa S, Rodriguez-Palomares JF, Xavier Valente F, Roque A, Feuchtner G, Plank F, Stechovsky C, Adla T, Schroeder S, Zelesny T, Gutberlet M, Woinke M, Karolyi M, Karady J, Donnelly P, Ball P, Dodd J, Hensey M, Mancone M, Ceccacci A, Berzina M, Zvaigzne L, Sakalyte G, Basevicius A, Ilnicka-Suckiel M, Kusmierz D, Faria R, Gama-Ribeiro V, Benedek I, Benedek T, Adjic F, Cankovic M, Berry C, Delles C, Thwaite E, Davis G, Knuuti J, Pietila M, Kepka C, Kruk M, Vidakovic R, Neskovic AN, Lecumberri I, Diez Gonzales I, Ruzsics B, Fisher M, Dewey M, Francone M; DISCHARGE Trial Group. Pilot study of the multicentre DISCHARGE Trial: image quality and protocol adherence results of computed tomography and invasive coronary angiography. Eur Radiol. 2020 Apr;30(4):1997-2009. doi: 10.1007/s00330-019-06522-z. Epub 2019 Dec 16.

    PMID: 31844958RESULT

  • Rieckmann N, Neumann K, Feger S, Ibes P, Napp A, Preuss D, Dreger H, Feuchtner G, Plank F, Suchanek V, Veselka J, Engstrom T, Kofoed KF, Schroder S, Zelesny T, Gutberlet M, Woinke M, Maurovich-Horvat P, Merkely B, Donnelly P, Ball P, Dodd JD, Hensey M, Loi B, Saba L, Francone M, Mancone M, Berzina M, Erglis A, Vaitiekiene A, Zajanckauskiene L, Haran T, Suckiel MI, Faria R, Gama-Ribeiro V, Benedek I, Rodean I, Adjic F, Cemerlic Adjic N, Rodriguez-Palomares J, Garcia Del Blanco B, Brooksbank K, Collison D, Davis G, Thwaite E, Knuuti J, Saraste A, Kepka C, Kruk M, Benedek T, Ratiu M, Neskovic AN, Vidakovic R, Diez I, Lecumberri I, Fisher M, Ruzsics B, Hollingworth W, Gutierrez-Ibarluzea I, Dewey M, Muller-Nordhorn J. Health-related qualify of life, angina type and coronary artery disease in patients with stable chest pain. Health Qual Life Outcomes. 2020 May 14;18(1):140. doi: 10.1186/s12955-020-01312-4.

    PMID: 32410687RESULT

  • Feger S, Ibes P, Napp AE, Lembcke A, Laule M, Dreger H, Bokelmann B, Davis GK, Roditi G, Diez I, Schroder S, Plank F, Maurovich-Horvat P, Vidakovic R, Veselka J, Ilnicka-Suckiel M, Erglis A, Benedek T, Rodriguez-Palomares J, Saba L, Kofoed KF, Gutberlet M, Adic F, Pietila M, Faria R, Vaitiekiene A, Dodd JD, Donnelly P, Francone M, Kepka C, Ruzsics B, Muller-Nordhorn J, Schlattmann P, Dewey M. Clinical pre-test probability for obstructive coronary artery disease: insights from the European DISCHARGE pilot study. Eur Radiol. 2021 Mar;31(3):1471-1481. doi: 10.1007/s00330-020-07175-z. Epub 2020 Sep 9.

    PMID: 32902743RESULT

  • Dodd JD, Bosserdt M, Oleksiak A, Vattay B, Bech Moller M, Benedek TM, Campbell F, Rodriguez-Palomares JF, Flynn S, Serna-Higuita LM, Sox H, Dewey M. Comparative Analysis of Cardiac CT and Invasive Coronary Angiography for Suspected Stable Coronary Artery Disease and Subsequent Functional Testing and Revascularization: A Prespecified Secondary DISCHARGE Randomized Trial Analysis. Radiol Cardiothorac Imaging. 2025 Aug;7(4):e240526. doi: 10.1148/ryct.240526.

    PMID: 40874840DERIVED

  • DISCHARGE Trial Group; Rieckmann N, Neumann K, Maurovich-Horvat P, Kofoed KF, Benedek T, Bosserdt M, Donnelly P, Rodriguez-Palomares J, Erglis A, Stechovsky C, Sakalyte G, Adic NC, Gutberlet M, Diez I, Davis G, Zimmermann E, Kepka C, Vidakovic R, Francone M, Ilnicka-Suckiel M, Plank F, Knuuti J, Faria R, Schroder S, Berry C, Saba L, Ruzsics B, Kubiak C, Hansen KS, Muller-Nordhorn J, Merkely B, Knudsen AD, Benedek I, Orr C, Valente FX, Zvaigzne L, Suchanek V, Zajanckauskiene L, Adic F, Woinke M, Waters D, Lecumberri I, Thwaite E, Laule M, Kruk M, Neskovic AN, Birtolo LI, Kusmierz D, Feuchtner G, Pietila M, Ribeiro VG, Drosch T, Delles C, Matta G, Fisher M, Szilveszter B, Larsen L, Ratiu M, Kelly S, Garcia Del Blanco B, Drobni ZD, Jurlander B, Regan S, Calabria HC, Boussoussou M, Engstrom T, Hodas R, Napp AE, Haase R, Feger S, Mohamed MMA, Dreger H, Rief M, Wieske V, Estrella M, Michallek F, Mark DB, Martus P, Dodd JD, Sox HC, Serna-Higuita LM, Dewey M. Health Status Outcomes After Computed Tomography or Invasive Coronary Angiography for Stable Chest Pain: A Prespecified Secondary Analysis of the DISCHARGE Randomized Clinical Trial. JAMA Cardiol. 2025 Jul 1;10(7):728-739. doi: 10.1001/jamacardio.2025.0992.

    PMID: 40366703DERIVED

  • DISCHARGE Trial Group; Bosserdt M, Serna-Higuita LM, Feuchtner G, Merkely B, Kofoed KF, Benedek T, Donnelly P, Rodriguez-Palomares J, Erglis A, Stechovsky C, Sakalyte G, Adic NC, Gutberlet M, Dodd JD, Diez I, Davis G, Zimmermann E, Kepka C, Vidakovic R, Francone M, Ilnicka-Suckiel M, Plank F, Knuuti J, Faria R, Schroder S, Berry C, Saba L, Ruzsics B, Rieckmann N, Kubiak C, Hansen KS, Muller-Nordhorn J, Szilveszter B, Sigvardsen PE, Benedek I, Orr C, Valente FX, Zvaigzne L, Suchanek V, Jankauskas A, Adic F, Woinke M, Hensey M, Lecumberri I, Thwaite E, Laule M, Kruk M, Neskovic AN, Mancone M, Kusmierz D, Pietila M, Ribeiro VG, Drosch T, Delles C, Porcu M, Fisher M, Boussoussou M, Kragelund C, Aurelian R, Kelly S, Garcia Del Blanco B, Rubio A, Maurovich-Horvat P, Hove JD, Rodean I, Regan S, Cuellar-Calabria H, Molnar L, Larsen L, Hodas R, Napp AE, Haase R, Feger S, Mohamed M, Neumann K, Dreger H, Rief M, Wieske V, Estrella M, Martus P, Sox HC, Dewey M. Age and Computed Tomography and Invasive Coronary Angiography in Stable Chest Pain: A Prespecified Secondary Analysis of the DISCHARGE Randomized Clinical Trial. JAMA Cardiol. 2024 Apr 1;9(4):346-356. doi: 10.1001/jamacardio.2024.0001.

    PMID: 38416472DERIVED

  • Mancone M, Mezquita AJV, Birtolo LI, Maurovich-Horvat P, Kofoed KF, Benedek T, Donnelly P, Rodriguez-Palomares J, Erglis A, Stechovsky C, Sakalyte G, Adic NC, Gutberlet M, Diez I, Davis G, Zimmermann E, Kepka C, Vidakovic R, Francone M, Ilnicka-Suckiel M, Plank F, Knuuti J, Faria R, Schroder S, Berry C, Saba L, Ruzsics B, Rieckmann N, Kubiak C, Hansen KS, Muller-Nordhorn J, Merkely B, Sigvardsen PE, Benedek I, Orr C, Valente FX, Zvaigzne L, Suchanek V, Jankauskas A, Adic F, Woinke M, Keane S, Lecumberri I, Thwaite E, Kruk M, Jovanovic V, Kusmierz D, Feuchtner G, Pietila M, Ribeiro VG, Drosch T, Delles C, Palmisano V, Fisher M, Drobni ZD, Kragelund C, Aurelian R, Kelly S, Del Blanco BG, Rubio A, Boussoussou M, Hove JD, Rodean I, Regan S, Calabria HC, Becker D, Larsen L, Hodas R, Napp AE, Haase R, Feger S, Mohamed M, Neumann K, Dreger H, Rief M, Wieske V, Douglas PS, Estrella M, Bosserdt M, Martus P, Serna-Higuita LM, Dodd JD, Dewey M. Impact of smoking in patients with suspected coronary artery disease in the randomised DISCHARGE trial. Eur Radiol. 2024 Jun;34(6):4127-4141. doi: 10.1007/s00330-023-10355-2. Epub 2023 Nov 22.

    PMID: 37991508DERIVED

  • DISCHARGE Trial Group; Kofoed KF, Bosserdt M, Maurovich-Horvat P, Rieckmann N, Benedek T, Donnelly P, Rodriguez-Palomares J, Erglis A, Stechovsky C, Sakalyte G, Adic F, Gutberlet M, Dodd JD, Diez I, Davis G, Zimmermann E, Kepka C, Vidakovic R, Francone M, Ilnicka-Suckiel M, Plank F, Knuuti J, Faria R, Schroder S, Berry C, Saba L, Ruzsics B, Kubiak C, Hansen KS, Muller-Nordhorn J, Merkely B, Jorgensen TS, Benedek I, Orr C, Valente FX, Zvaigzne L, Suchanek V, Zajanckauskiene L, Cankovic M, Woinke M, Keane S, Lecumberri I, Thwaite E, Laule M, Kruk M, Neskovic AN, Mancone M, Kusmierz D, Feuchtner G, Pietila M, Ribeiro VG, Drosch T, Delles C, Loi B, Fisher M, Szilveszter B, Sigvardsen PE, Ratiu M, Kelly S, Garcia Del Blanco B, Rubio A, Drobni ZD, Kragelund C, Rodean I, Regan S, Calabria HC, Boussoussou M, Engstrom T, Hodas R, Napp AE, Haase R, Feger S, Mohamed MMA, Serna-Higuita LM, Neumann K, Dreger H, Rief M, Wieske V, Estrella M, Martus P, Dewey M. Comparative effectiveness of initial computed tomography and invasive coronary angiography in women and men with stable chest pain and suspected coronary artery disease: multicentre randomised trial. BMJ. 2022 Oct 19;379:e071133. doi: 10.1136/bmj-2022-071133.

    PMID: 36261169DERIVED

  • DISCHARGE Trial Group; Maurovich-Horvat P, Bosserdt M, Kofoed KF, Rieckmann N, Benedek T, Donnelly P, Rodriguez-Palomares J, Erglis A, Stechovsky C, Sakalyte G, Cemerlic Adic N, Gutberlet M, Dodd JD, Diez I, Davis G, Zimmermann E, Kepka C, Vidakovic R, Francone M, Ilnicka-Suckiel M, Plank F, Knuuti J, Faria R, Schroder S, Berry C, Saba L, Ruzsics B, Kubiak C, Gutierrez-Ibarluzea I, Schultz Hansen K, Muller-Nordhorn J, Merkely B, Knudsen AD, Benedek I, Orr C, Xavier Valente F, Zvaigzne L, Suchanek V, Zajanckauskiene L, Adic F, Woinke M, Hensey M, Lecumberri I, Thwaite E, Laule M, Kruk M, Neskovic AN, Mancone M, Kusmierz D, Feuchtner G, Pietila M, Gama Ribeiro V, Drosch T, Delles C, Matta G, Fisher M, Szilveszter B, Larsen L, Ratiu M, Kelly S, Garcia Del Blanco B, Rubio A, Drobni ZD, Jurlander B, Rodean I, Regan S, Cuellar Calabria H, Boussoussou M, Engstrom T, Hodas R, Napp AE, Haase R, Feger S, Serna-Higuita LM, Neumann K, Dreger H, Rief M, Wieske V, Estrella M, Martus P, Dewey M. CT or Invasive Coronary Angiography in Stable Chest Pain. N Engl J Med. 2022 Apr 28;386(17):1591-1602. doi: 10.1056/NEJMoa2200963. Epub 2022 Mar 4.

    PMID: 35240010DERIVED

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Marc Dewey, Prof. Dr.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 15, 2015

First Posted

March 27, 2015

Study Start

October 3, 2015

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations

PT(1)DK(1)GB(3)DE(3)LI(1)CZ(1)AU(1)IE(1)HU(1)PL(1)ES(1)LA(1)IT(2)RO(1)SE(1)