Clinical trial NCT02400229: Diagnostic Imaging Strategies for Patients With Stable Chest Pain and Intermediate Risk of Coronary Artery Disease
Official title: Diagnostic Imaging Strategies for Patients With Stable Chest Pain and Intermediate Risk of Coronary Artery Disease: Comparative Effectiveness Research of Existing Technologies) - A Pragmatic Randomised Controlled Trial of CT Versus ICA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
stable chest pain
intermediate pretest probability
pragmatic randomised controlled trial
coronary computed tomography
angiography
invasive coronary angiography
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 3546
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

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)

Primary outcomes:
measure: Major Adverse Cardiovascular Event
timeFrame: 1 minute after randomisation to CT/ICA diagnostic procedure and during follow-up
Secondary outcomes:
measure: Likelihood of receiving coronary intervention in different European countries
timeFrame: at baseline, 1-year follow-up and final follow-up up to a max of 4 years
measure: Rates of percutaneous coronary intervention and use of intracoronary techniques different European countries
timeFrame: at baseline, 1-year follow-up and final follow-up up to a max of 4 years
measure: Patient management in different European countries
timeFrame: at baseline, 1-year follow-up and final follow-up up to a max of 4 years
measure: Follow-up strategies in different European countries
timeFrame: at baseline, 1-year follow-up and final follow-up up to a max of 4 years
measure: European differences in occurrence and extent of Coronary Artery Disease in regards to city versus rural lifestyle
timeFrame: at baseline, 1-year follow-up and final follow-up up to a max of 4 years
measure: European and local differences in patient consent of sites
timeFrame: at baseline, 1-year follow-up and final follow-up up to a max of 4 years
measure: Comparison in the Coronary Computed Tomographic Angiography and Invasive Coronary Angiography group:Occurrence of Minor Adverse Cardiovascular Events
timeFrame: 1 minute after randomisation to CT/ICA diagnostic procedure and during follow-up
measure: Comparison in the Computed Tomography Angiography and Invasive coronary Angiography group: Percutaneous Coronary Intervention and Coronary Artery Bypass Graft
timeFrame: during the CTA/ICA examination, up to 48h after hours after the final procedure related to the test randomized to, 1-year follow-up and final follow-up to a max of 4 years
measure: Comparison in the Computer Tomography Angiography and Invasive Coronary Angiography group: Rates of patients on dialysis
timeFrame: during the CTA /ICA examination, up to 48h after hours after the final procedure related to the test randomized to, 1-year follow-up and final follow-up to a max of 4 years
measure: Comparison in the Computer Tomography Angiography and Invasive Coronary Angiography group: Rate of coronary anatomical anomalies
timeFrame: during the CTA /ICA examination, up to 48h after hours after the final procedure related to the test randomized to, 1-year follow-up and final follow-up to a max of 4 years
measure: Comparison in the computer tomography angiography and invasive coronary angiography group: Rates of patients undergoing further cardiac diagnostics
timeFrame: up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow up to a max of 4 years
measure: Comparison in the computer tomography angiography and invasive coronary angiography group: Rates of coronary interventions
timeFrame: up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow up to a max of 4 years
measure: Analysis of the influence of prior computer tomography angiography on invasive coronary angiography and percutaneous coronary intervention
timeFrame: up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow up to a max of 4 years
measure: Comparison of cumulative contrast agent amount in the two arms
timeFrame: up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow up to a max of 4 years
measure: Comparison in the computer tomography angiography and invasive coronary angiography group: Number/proportion of patients undergoing coronary revascularization
timeFrame: up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow up to a max of 4 years
measure: Comparison in the computer tomography angiography and invasive coronary angiography group: Distribution in the mode of revascularization: percutaneous coronary intervention vs. coronary artery bypass graft
timeFrame: up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow up to a max of 4 years
measure: Comparison of Quality of Life between treatment regimens.
timeFrame: at 1-year follow-up and final follow-up to a max of 4 years
measure: Geographical distribution of risk factors for Major Cardiovascular Events and Minor Cardiovascular Events and other events
timeFrame: at 1-year follow-up and final follow-up to a max of 4 years
measure: Extent of Coronary Artery Disease
timeFrame: at 1-year follow-up and final follow-up to a max of 4 years
measure: Time from randomisation to Invasive Coronary Angiography in both groups
timeFrame: at 1-year follow-up and final follow-up to a max of 4 years
measure: Time from randomisation to first coronary revascularisation in both groups
timeFrame: at 1-year follow-up and final follow-up to a max of 4 years
measure: Completeness of revascularisation for Percutaneous Coronary Intervention single vessel vs multivessel Percutaneous Coronary Intervention and Coronary Artery Bypass Graft; stent use (bare metal vs drug eluting)
timeFrame: at 1-year follow-up and final follow-up to a max of 4 years
measure: Information on surgical procedures i.e. isolated Coronary Artery Bypass Graft, Coronary Artery Bypass graft with valve replacement, Coronary Artery Bypass Graft with aortic surgery
timeFrame: at 1-year follow-up and final follow-up to a max of 4 years
measure: Comparison in the Computer Tomography Angiography and Invasive Coronary Angiography group: procedures and outcomes in relation to age
timeFrame: at 1-year follow-up and final follow-up to a max of 4 years
measure: Comparison in the Computer Tomography Angiography and Invasive Coronary Angiography group: procedures and outcomes in relation to body mass index and obesity
timeFrame: at 1-year follow-up and final follow-up to a max of 4 years
measure: Reduction of angina pectoris intensity
timeFrame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years
measure: Validation of different questionnaires to predict Major and Minor Adverse Cardiac Events
timeFrame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years
measure: Occurrence of adverse events due to medication
timeFrame: during the procedure or within 48 hours post last related procedure
measure: Occurrence of adverse events related to venous or arterial puncture
timeFrame: during the procedure or within 48 hours post last related procedure
measure: Occurrence of cardiac arrhythmia
timeFrame: during the procedure or within 48 hours post last related procedure
measure: Rates of contrast-induced nephropathy
timeFrame: up to 48h after hours after the final procedure related to the test randomised to
measure: Infections
timeFrame: during the procedure or within 48 hours post last related procedure
measure: Influence of experience of examiners on events
timeFrame: during the procedure or within 48 hours post last related procedure
measure: Comparison of occurrence of procedural complications related to Invasive Coronary Angiography
timeFrame: during the procedure or within 48 hours post last related procedure
measure: Procedural complications related to Invasive Coronary Angiography
timeFrame: during the procedure or within 48 hours post last related procedure
measure: Procedural complications during or after revascularisation
timeFrame: during the procedure or within 48 hours post last related procedure
measure: Occurrence of other adverse events and serious adverse events in the Invasive Coronary Angiography group
timeFrame: during the procedure or within 48 hours post last related procedure
measure: Comparison of incidental findings in Computed Tomography Angiography and Invasive Coronary Angiography group and potential benefits and harms of findings Analysis of prevalence non-coronary cardiac and non-cardiac causes of symptoms
timeFrame: during CTA and ICA examination, up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow-up to a max of 4 years
measure: Comparison of incidental findings in both arms and potential benefits and harms of findings:Influence of non-coronary cardiac and non-cardiac findings on Major Adverse Cardiac Events, non-cardiac events and Quality of Life
timeFrame: during CTA and ICA examination, up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow-up to a max of 4 years
measure: Comparison of incidental findings in Computed Tomography Angiography and Invasive Coronary Angiography group and potential benefits and harms of findings: Rate for malignancy in nodules seen on Computed Tomography Angiography
timeFrame: during CTA and ICA examination, up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow-up to a max of 4 years
measure: Comparison of incidental findings in Computed Tomography Angiography and Invasive Coronary Angiography group and potential benefits and harms of findings
timeFrame: during CTA and ICA examination, up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow-up to a max of 4 years
measure: Comparison of incidental findings in Computed Tomography Angiography and Invasive Coronary Angiography group and potential benefits and harms of findings: Rate of death from cancer in both groups
timeFrame: at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Comparison of incidental findings in Computed Tomography Angiography and Invasive Coronary Angiography group and potential benefits and harms of findings:Rates of unnecessary follow-up procedures
timeFrame: at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Analysis of interobserver variability (site versus core lab)
timeFrame: up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Percent diameter stenosis correlation and agreement by both diagnostic tests in patients who underwent Invasive Coronary Angiography in the Computed Tomography Angiography group after positive or non-diagnostic findings
timeFrame: up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Non-diagnostic Computed Tomography Angiography and Invasive Coronary Angiography
timeFrame: up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Correlation between percent diameter stenosis
timeFrame: up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Prevalence of sinus node artery being a side branch of Left Coronary Artery or Right Coronary Artery
timeFrame: up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Prevalence of left, intermediate, and right coronary distribution type
timeFrame: up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Improvement of selection of distal coronary segments used for CABG-anastomosis by CT in comparison to ICA alone (especially heavy calcification detection) as assessed by the cardiac surgeons.
timeFrame: at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Relation of plaque characterisation and quantification by core lab and Major and Minor Adverse Cardiac Events at the two follow-up results
timeFrame: at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Image quality of Computed Tomography by core lab read and flow and concentration of contrast agent used intravenously
timeFrame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial
measure: Coronary artery dimensions
timeFrame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial
measure: Noise in Computed Tomography Angiography imaging
timeFrame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial
measure: Factors that influence the image quality of Computed Tomography Angiography
timeFrame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial
measure: Accuracy and agreement of RCADIA system
timeFrame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial
measure: 10-step Guide to cardiac CT
timeFrame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial
measure: Semi-qualitative analysis
timeFrame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial
measure: Qualitative analysis
timeFrame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial
measure: Heart rate reduction achieved in Computed Tomography by the DISCHARGE betablocker protocol
timeFrame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial
measure: Heart rate reduction achieved in subgroups
timeFrame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial
measure: Heart rate reduction achieved with conscious sedation, if used, for Computed Tomography
timeFrame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial
measure: Correlation of extent of Coronary Artery Disease and a high calcium score
timeFrame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial
measure: Characterisation of plaques
timeFrame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial
measure: Differences in plaque characteristics
timeFrame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial
measure: Comparison of Computed Tomography Angiography and intracoronary techniques
timeFrame: during the Computed Tomography examination and up to 6 months after the pragmatic Randomised Controlled Trial
measure: Influence of statin treatment on plaque development
timeFrame: during the Computed Tomography examination and up to 6 months after the pragmatic Randomised Controlled Trial
measure: Correlation of effective dose and the diagnostic portion of Invasive Coronary Angiography with weight and body-mass index of the patient.
timeFrame: during the Invasive Coronary Angiography examination, at 1-year follow-up and at final follow-up to a maximum of 4 years
measure: Correlation of effective dose of and contrast agent amount used for Invasive Coronary Angiography with severity of Coronary Artery Disease
timeFrame: during the Invasive Coronary Angiography examination, at 1-year follow-up and at final follow-up to a maximum of 4 years
measure: Rate of follow-up Invasive Coronary Angiographies and Percutaneous Coronary Interventions more than 2 months after initial Computed Tomography/Invasive Coronary Angiography and up to first and last follow-up
timeFrame: during the Invasive Coronary Angiography examination, at 1-year follow-up and at final follow-up to a maximum of 4 years
measure: Correlation of the number of projections for the right and left coronary artery with effective dose of Invasive Coronary Angiography
timeFrame: during the Invasive Coronary Angiography examination, at 1-year follow-up and at final follow-up to a maximum of 4 years
measure: Rates of left ventriculography performed
timeFrame: during the Invasive Coronary Angiography examination, at 1-year follow-up and at final follow-up to a maximum of 4 years
measure: Rates of planned cross-over from Computed Tomography to Invasive Coronary Angiography
timeFrame: up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Comparison of cross-over patients (from Computed Tomography to Invasive Coronary Angiography) to non-cross-over-patients
timeFrame: up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Correlation of Computed Tomography Angiography and/or Invasive Coronary Angiography with the results of imaging ischemia tests
timeFrame: at baseline, up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Correlation between imaging ischemia tests and invasive Fractional Flow Reserve if done
timeFrame: at baseline, up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Rates of imaging ischemia tests recommended
timeFrame: at baseline, up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Comparison of diagnostic accuracy of imaging ischemia tests
timeFrame: at baseline, up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Comparison of imaging ischemia results with Computed Tomography Angiography and Invasive Coronary Angiography results for prediction of Major and Minor Cardiac Adverse Events
timeFrame: at baseline, up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Correlation between imaging ischemia results and coronary stenosis as well as plaque composition and characterisation findings by Computed Tomography Angiography
timeFrame: at baseline, up to 48h after the final procedure related to the test randomised to, at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Rate of revascularisations recommended and performed after Computed Tomography Angiography and positive or negative imaging ischemia tests in comparison to Invasive Coronary Angiography arm within two month after the initial test
timeFrame: at baseline, at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Correlation of the results of study- Computed Tomography Angiography, recommended imaging ischemia test and Invasive Coronary Angiography in patients with respective study course
timeFrame: at baseline, at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Occurrence of procedural events in imaging ischemia testing
timeFrame: at baseline, at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Correlation of intensity and reduction of angina pectoris
timeFrame: at baseline, at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Analysis of patient acceptance ("preference questionnaire") of Computed Tomography Angiography and Invasive Coronary Angiography
timeFrame: at baseline, up to 48h after hours after the final procedure related to the test randomized to, 1-year follow-up and final follow-up to a max of 4 years
measure: Patient acceptance of informed consent, preparation and procedural aspects of the test performed
timeFrame: at baseline, up to 48h after hours after the final procedure related to the test randomized to, 1-year follow-up and final follow-up to a max of 4 years
measure: Effective radiation dose for Computed Tomography Angiography and Invasive Coronary Angiography
timeFrame: up to 48h after the final procedure related to the test randomised, at 1-year follow-up and final follow up to a max of 4 years
measure: Reduction of radiation exposure by using coronary artery calcium score information
timeFrame: up to 48h after the final procedure related to the test randomised, at 1-year follow-up and final follow up to a max of 4 years
measure: Comparison of radiation dose in Invasive Coronary Angiography and Computed Tomography Angiography: pilot study versus non-study patients
timeFrame: during Computed Tomography Angiography and Invasive Coronary Angiography Examination
measure: Validation of the coronary artery disease DISCHARGE and COME-CCT pre-test probability calculators
timeFrame: at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Comparison of the ability of the DISCHARGE and COME-CCT pre-test probability calculators to predict Coronary Artery Disease indifferent genders
timeFrame: at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Ability of the DISCHARGE and COME-CCT pre-test probability calculators to predict Coronary Artery Disease
timeFrame: at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Potential advantage of the DISCHARGE and COME-CCT calculators
timeFrame: at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Predictive value of the DISCHARGE calculator in patients who could not be included in the trial due to their very low pre-test probability (<10%)
timeFrame: at 1-year follow-up and final follow-up to a max of 4 years
measure: Predictive value of the DISCHARGE calculator
timeFrame: at 1-year follow-up and final follow-up to a max of 4 years
measure: Development and validation of a novel pre-test probability calculator
timeFrame: at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Ability of the DISCHARGE and COME-CCT calculators to predict Major and Minor Adverse Cardiac Events
timeFrame: at 1-year follow-up and final follow-up to a maximum of 4 years
measure: Cost-Effectiveness Analysis
timeFrame: at 1-year follow-up and final follow-up to a max of 4 years
measure: Cost-Utility Analysis
timeFrame: at 1-year follow-up and final follow-up to a max of 4 years
measure: Comparison of cost-effectiveness analysis and cost-utility analysis in different European countries
timeFrame: at 1-year follow-up and final follow-up to a max of 4 years
measure: Average days off work per patient by clinical site during follow up
timeFrame: at 1-year follow-up and final follow-up to a max of 4 years
measure: Days in hospital per patient by clinical site during follow up
timeFrame: at 1-year follow-up and final follow-up to a max of 4 years
measure: Additional diagnostic tests during follow-up by clinical site
timeFrame: at 1-year follow-up and final follow-up to a max of 4 years
measure: Additional treatments during follow-up by clinical site
timeFrame: at 1-year follow-up and final follow-up to a max of 4 years
measure: Pragmatic assessment of staff involvement time and material use - completion of questionnaires
timeFrame: up to a maximum of 2 years after completion of pilot study at all sites
measure: Differences in staff involvement time for Computed Tomography Angiography and Invasive Coronary Angiography in different clinical sites
timeFrame: up to a maximum of 2 years after completion of pilot study at all sites
measure: Differences in consumption of materials in different clinical sites
timeFrame: up to a maximum of 2 years after completion of pilot study at all sites
measure: Comparison of population of pilot study between the different European clinical sites
timeFrame: up to a maximum of 2 years after completion of pilot study at all sites
measure: Correlation of previous cardiac examination results of patients included in the pilot study with result of Computed Tomography Angiography and Invasive Coronary Angiography
timeFrame: up to a maximum of 2 years after completion of pilot study at all sites
measure: Comparison of hospitalisation after Invasive Coronary Angiography in different European clinical sites
timeFrame: up to a maximum of 2 years after completion of pilot study at all sites
measure: Assessment of non-diagnostic segments in Computed Tomography Angiography and Invasive Coronary Angiography in the pilot study
timeFrame: up to a maximum of 2 years after completion of pilot study at all sites
measure: Assessment of major cardiovascular adverse events in the pilot study
timeFrame: up to a maximum of 2 years after completion of pilot study at all sites
measure: Health related Quality of Life and Lifestyle
timeFrame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years
measure: Acceptance of time trade-off question in the pilot study
timeFrame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years
measure: Comparison of the health instruments
timeFrame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years
measure: Gender differences regarding all aspects of medical history
timeFrame: : at baseline, at 1-year follow-up and final follow-up to a max of 4 years
measure: Gender differences in radiation exposure and gender
timeFrame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years
measure: Gender differences regarding Quality of Life, lifestyle and socioeconomic status
timeFrame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years
measure: Gender differences in examination results
timeFrame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years
measure: Gender differences of coronary plaque characteristics determined by Computed Tomography
timeFrame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years
measure: Gender differences of myocardial resting blood flow / tissue characteristics determined by Computed Tomography Angiography
timeFrame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years
measure: Diagnostic value of Computed Tomography in men vs women - frequency of true positive findings in patients referred for Invasive Coronary Angiography
timeFrame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years
measure: Gender differences of pulmonary findings of Computed Tomography Angiography
timeFrame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years
measure: Gender differences of structural Computed Tomography Angiography findings
timeFrame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years
measure: Analysis of occurrence in Major Adverse Cardiac Events in subgroups
timeFrame: at baseline, at 1-year follow-up and final follow up to a max of 4 years
measure: Major Adverse Cardiac Events in different composites
timeFrame: at baseline, at 1-year follow-up and final follow up to a max of 4 years
measure: Occurrence of Myocardial Infarction and stroke
timeFrame: at baseline, at 1-year follow-up and final follow up to a max of 4 years
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck
city: Prague
country: Czechia
facility: Fakultni Nemocnice V Motole
city: Copenhagen
country: Denmark
facility: Region Hovedstaden
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Göppingen
country: Germany
facility: Alb Fils Kliniken Gmbh
city: Leipzig
country: Germany
facility: Universitaet Leipzig
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Dublin
country: Ireland
facility: University College Dublin, National University of Ireland
city: Cagliari
country: Italy
facility: Universita Degli Studi Di Cagliari
city: Rome
country: Italy
facility: Universita Degli Studi Di Roma La Sapienza
city: Riga
country: Latvia
facility: Paula Stradina Kliniska Universitates Slimnica As
city: Kaunas
country: Lithuania
facility: Lietuvos Sveikatos Mokslu Universitetas
city: Wroclaw
country: Poland
facility: Wojewodzki Szpital Specjalistyczny We Wroclawiu
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia/Espinho Epe
city: Targu Mures
country: Romania
facility: Cardio Med Srl
city: Novi Sad
country: Serbia
facility: Institut Za Kardiovaskularne Bolesti Vojvodine
city: Barcelona
country: Spain
facility: Institut Catala de La Salut
city: Belfast
country: United Kingdom
facility: South Eastern Health and Social Care Trust Nhs
city: Glasgow
country: United Kingdom
facility: University of Glasgow
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital Nhs Foundation Trust
Study officials:
affiliation: Charite University, Berlin, Germany
name: Marc Dewey, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.