Diagnostic Imaging Strategies for Patients With Stable Chest Pain and Intermediate Risk of Coronary Artery Disease

NCT ID: NCT02400229

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3546 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-03
• Study Completion Date: 2022-03-31

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.

Detailed Description

The primary objective of this prospective pragmatic randomised controlled trial (PRCT) in 3546 patients is to evaluate the possible superiority of a CT-based patient management over an ICA-based management strategy in stable chest pain patients with intermediate pretest probability (10-60%) of coronary artery disease. The primary outcome measure is the occurrence of MACE (MACE = major adverse cardiovascular events; defined as at least one of the following: cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke) after a maximum follow-up of 4 years after CT or ICA. Secondary outcomes include health related quality of life, cost-effectiveness, cross-over to ICA/CT. Procedural complications are classified into major and minor. Major procedural complications are a composite end-point and include death, nonfatal stroke, nonfatal myocardial infarction, and further complications prolonging hospitalization by at least 24 hrs,as well as dissection (coronary, aorta), cardiogenic shock, cardiac tamponade, retroperitoneal bleeding, cardiac arrhythmia (ventricular tachycardia, ventricular fibrillation), cardiac arrest. Possible minor procedural complications: Hematoma at the puncture site, secondary bleeding at the puncture site, bradycardia, angina without infarction, allergoid contrast agent reaction, stent migration, hypotension requiring treatment, headache, hyperthyreodism, skin tissue and nerve injuries, extravasate, cardiac arrhythmia, contrast-induced nephropathy (CIN), infections, femoral arterial occlusion (or arterial access vessel) or dissection, new requirement for dialysis, DVT/pulmonary embolism, closure or injury of vessels, injury of the heart (e.g. valve or myocardium), , perforation, gastrointestinal bleeding, genital-urinary bleeding, other major bleeding, red blood cell (RBC)/whole blood transfusion, twisting or rupture of the catheter part, other equipment mishaps (e.g. retained foreign body guidewire fracture), development of arterio-venous fistula(s), development of pseudo aneurysm at puncture site, dissection (except coronary dissection), permanent edema (e.g. due to lymphatic congestion at puncture site), embolisation of central or peripheral vessels due to thromboembolis, acute closure of coronary vessels, stent infection, heart failure, wrong patient or wrong procedure and other.

This study is a European multicentre study conducted at 26 clinical centres in 16 European countries and is methodologically based on the single-centre CAD-Man trial conducted by Charité (NCT00844220). The pragmatic approach of the study ensures generating practical and usable outcomes for clinical decision-making according to comparative effectiveness research methodology.

In a preceding pilot study, data for cost-effectiveness analyses and image-quality analyses are collected and methods are defined for implementation in the main PRCT. Also appropriate instruments for health related quality of life are being chosen.

DISCHARGE receives funding from the 7th Framework Programme of the European Commission (EC-GA 603266).

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Computed Tomography Angiography (CTA)

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

Group Type: EXPERIMENTAL

Computed tomography angiography (cardiac CT)

Intervention Type: PROCEDURE

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

Invasive coronary angiography (ICA)

Invasive coronary angiography

Group Type: ACTIVE_COMPARATOR

Invasive coronary angiography (ICA)

Intervention Type: PROCEDURE

Clinical management/treatment decisions based on invasive coronary angiography

Interventions

Computed tomography angiography (cardiac CT)

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

Intervention Type: PROCEDURE

Invasive coronary angiography (ICA)

Clinical management/treatment decisions based on invasive coronary angiography

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Marc Dewey

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc Dewey, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Medizinische Universitaet Innsbruck

Innsbruck, , Austria

Fakultni Nemocnice V Motole

Prague, , Czechia

Region Hovedstaden

Copenhagen, , Denmark

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Alb Fils Kliniken Gmbh

Göppingen, , Germany

Universitaet Leipzig

Leipzig, , Germany

Semmelweis Egyetem

Budapest, , Hungary

University College Dublin, National University of Ireland

Dublin, , Ireland

Universita Degli Studi Di Cagliari

Cagliari, , Italy

Universita Degli Studi Di Roma La Sapienza

Rome, , Italy

Paula Stradina Kliniska Universitates Slimnica As

Riga, , Latvia

Lietuvos Sveikatos Mokslu Universitetas

Kaunas, , Lithuania

Wojewodzki Szpital Specjalistyczny We Wroclawiu

Wroclaw, , Poland

Centro Hospitalar de Vila Nova de Gaia/Espinho Epe

Vila Nova de Gaia, , Portugal

Cardio Med Srl

Târgu Mureş, , Romania

Institut Za Kardiovaskularne Bolesti Vojvodine

Novi Sad, , Serbia

Institut Catala de La Salut

Barcelona, , Spain

South Eastern Health and Social Care Trust Nhs

Belfast, , United Kingdom

University of Glasgow

Glasgow, , United Kingdom

Aintree University Hospital Nhs Foundation Trust

Liverpool, , United Kingdom

Countries

Austria; Czechia; Denmark; Germany; Hungary; Ireland; Italy; Latvia; Lithuania; Poland; Portugal; Romania; Serbia; Spain; United Kingdom

References

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Related Links

http://www.dischargetrial.eu

Project homepage

https://cordis.europa.eu/project/rcn/110447/factsheet/en

European Commission Project homepage

Other Identifiers

EC-GA 603266

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Z 5 - 22462/2 - 2014-001

Identifier Type: OTHER

Identifier Source: secondary_id

EA1/294/13

Identifier Type: -

Identifier Source: org_study_id