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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 March 2021
• Main ID: NCT02400229
• Date of registration: 15/01/2015
• Prospective Registration: Yes
• Primary sponsor: Charite University, Berlin, Germany
• Public title: Diagnostic Imaging Strategies for Patients With Stable Chest Pain and Intermediate Risk of Coronary Artery Disease DISCHARGE
• Scientific 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
• Date of first enrolment: October 3, 2015
• Target sample size: 3546
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02400229
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

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

Contacts

• Name: Marc Dewey, Prof. Dr.
• Affiliation: Charite University, Berlin, Germany

Key inclusion & exclusion 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)



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Intervention(s)

Procedure: Invasive coronary angiography (ICA)

Procedure: Computed tomography angiography (cardiac CT)

Primary Outcome(s)

Major Adverse Cardiovascular Event [Time Frame: 1 minute after randomisation to CT/ICA diagnostic procedure and during follow-up]

Secondary Outcome(s)

Accuracy and agreement of RCADIA system [Time Frame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial]

Ability of the DISCHARGE and COME-CCT pre-test probability calculators to predict Coronary Artery Disease [Time Frame: at 1-year follow-up and final follow-up to a maximum of 4 years]

Comparison of hospitalisation after Invasive Coronary Angiography in different European clinical sites [Time Frame: up to a maximum of 2 years after completion of pilot study at all sites]

Acceptance of time trade-off question in the pilot study [Time Frame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years]

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 [Time Frame: at 1-year follow-up and final follow-up to a maximum of 4 years]

Gender differences of myocardial resting blood flow / tissue characteristics determined by Computed Tomography Angiography [Time Frame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years]

Comparison of Quality of Life between treatment regimens. [Time Frame: at 1-year follow-up and final follow-up to a max of 4 years]

Geographical distribution of risk factors for Major Cardiovascular Events and Minor Cardiovascular Events and other events [Time Frame: at 1-year follow-up and final follow-up to a max of 4 years]

Coronary artery dimensions [Time Frame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial]

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 [Time Frame: 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]

Analysis of interobserver variability (site versus core lab) [Time Frame: 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]

10-step Guide to cardiac CT [Time Frame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial]

Analysis of the influence of prior computer tomography angiography on invasive coronary angiography and percutaneous coronary intervention [Time Frame: 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]

Comparison in the computer tomography angiography and invasive coronary angiography group: Number/proportion of patients undergoing coronary revascularization [Time Frame: 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]

Analysis of occurrence in Major Adverse Cardiac Events in subgroups [Time Frame: at baseline, at 1-year follow-up and final follow up to a max of 4 years]

Additional diagnostic tests during follow-up by clinical site [Time Frame: at 1-year follow-up and final follow-up to a max of 4 years]

Assessment of major cardiovascular adverse events in the pilot study [Time Frame: up to a maximum of 2 years after completion of pilot study at all sites]

Comparison in the Computer Tomography Angiography and Invasive Coronary Angiography group: procedures and outcomes in relation to body mass index and obesity [Time Frame: at 1-year follow-up and final follow-up to a max of 4 years]

Additional treatments during follow-up by clinical site [Time Frame: at 1-year follow-up and final follow-up to a max of 4 years]

Analysis of patient acceptance ("preference questionnaire") of Computed Tomography Angiography and Invasive Coronary Angiography [Time Frame: 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]

Comparison of Computed Tomography Angiography and intracoronary techniques [Time Frame: during the Computed Tomography examination and up to 6 months after the pragmatic Randomised Controlled Trial]

Average days off work per patient by clinical site during follow up [Time Frame: at 1-year follow-up and final follow-up to a max of 4 years]

Comparison in the Computer Tomography Angiography and Invasive Coronary Angiography group: Rate of coronary anatomical anomalies [Time Frame: 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]

Prevalence of sinus node artery being a side branch of Left Coronary Artery or Right Coronary Artery [Time Frame: 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]

Comparison of cross-over patients (from Computed Tomography to Invasive Coronary Angiography) to non-cross-over-patients [Time Frame: 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]

Comparison in the Coronary Computed Tomographic Angiography and Invasive Coronary Angiography group:Occurrence of Minor Adverse Cardiovascular Events [Time Frame: 1 minute after randomisation to CT/ICA diagnostic procedure and during follow-up]

Comparison in the Computer Tomography Angiography and Invasive Coronary Angiography group: procedures and outcomes in relation to age [Time Frame: at 1-year follow-up and final follow-up to a max of 4 years]

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 [Time Frame: at baseline, at 1-year follow-up and final follow-up to a maximum of 4 years]

Correlation between imaging ischemia tests and invasive Fractional Flow Reserve if done [Time Frame: 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]

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 [Time Frame: 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]

Comparison of population of pilot study between the different European clinical sites [Time Frame: up to a maximum of 2 years after completion of pilot study at all sites]

Comparison of radiation dose in Invasive Coronary Angiography and Computed Tomography Angiography: pilot study versus non-study patients [Time Frame: during Computed Tomography Angiography and Invasive Coronary Angiography Examination]

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 [Time Frame: 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]

Correlation between percent diameter stenosis [Time Frame: 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]

Comparison of the ability of the DISCHARGE and COME-CCT pre-test probability calculators to predict Coronary Artery Disease indifferent genders [Time Frame: at 1-year follow-up and final follow-up to a maximum of 4 years]

Comparison of the health instruments [Time Frame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years]

Correlation of extent of Coronary Artery Disease and a high calcium score [Time Frame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial]

Comparison of cost-effectiveness analysis and cost-utility analysis in different European countries [Time Frame: at 1-year follow-up and final follow-up to a max of 4 years]

Assessment of non-diagnostic segments in Computed Tomography Angiography and Invasive Coronary Angiography in the pilot study [Time Frame: up to a maximum of 2 years after completion of pilot study at all sites]

Correlation of the results of study- Computed Tomography Angiography, recommended imaging ischemia test and Invasive Coronary Angiography in patients with respective study course [Time Frame: at baseline, at 1-year follow-up and final follow-up to a maximum of 4 years]

Correlation of Computed Tomography Angiography and/or Invasive Coronary Angiography with the results of imaging ischemia tests [Time Frame: 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]

Correlation of previous cardiac examination results of patients included in the pilot study with result of Computed Tomography Angiography and Invasive Coronary Angiography [Time Frame: up to a maximum of 2 years after completion of pilot study at all sites]

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 [Time Frame: 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]

Cost-Effectiveness Analysis [Time Frame: at 1-year follow-up and final follow-up to a max of 4 years]

Diagnostic value of Computed Tomography in men vs women - frequency of true positive findings in patients referred for Invasive Coronary Angiography [Time Frame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years]

Effective radiation dose for Computed Tomography Angiography and Invasive Coronary Angiography [Time Frame: 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]

Rates of imaging ischemia tests recommended [Time Frame: 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]

Days in hospital per patient by clinical site during follow up [Time Frame: at 1-year follow-up and final follow-up to a max of 4 years]

Cost-Utility Analysis [Time Frame: at 1-year follow-up and final follow-up to a max of 4 years]

Differences in consumption of materials in different clinical sites [Time Frame: up to a maximum of 2 years after completion of pilot study at all sites]

Differences in plaque characteristics [Time Frame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial]

Image quality of Computed Tomography by core lab read and flow and concentration of contrast agent used intravenously [Time Frame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial]

Rates of left ventriculography performed [Time Frame: during the Invasive Coronary Angiography examination, at 1-year follow-up and at final follow-up to a maximum of 4 years]

Comparison of diagnostic accuracy of imaging ischemia tests [Time Frame: 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]

Non-diagnostic Computed Tomography Angiography and Invasive Coronary Angiography [Time Frame: 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]

European differences in occurrence and extent of Coronary Artery Disease in regards to city versus rural lifestyle [Time Frame: at baseline, 1-year follow-up and final follow-up up to a max of 4 years]

Comparison of incidental findings in Computed Tomography Angiography and Invasive Coronary Angiography group and potential benefits and harms of findings [Time Frame: 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]

Gender differences of pulmonary findings of Computed Tomography Angiography [Time Frame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years]

Comparison of occurrence of procedural complications related to Invasive Coronary Angiography [Time Frame: during the procedure or within 48 hours post last related procedure]

Development and validation of a novel pre-test probability calculator [Time Frame: at 1-year follow-up and final follow-up to a maximum of 4 years]

Occurrence of Myocardial Infarction and stroke [Time Frame: at baseline, at 1-year follow-up and final follow up to a max of 4 years]

Factors that influence the image quality of Computed Tomography Angiography [Time Frame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial]

Correlation between imaging ischemia results and coronary stenosis as well as plaque composition and characterisation findings by Computed Tomography Angiography [Time Frame: 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]

Patient management in different European countries [Time Frame: at baseline, 1-year follow-up and final follow-up up to a max of 4 years]

Gender differences regarding Quality of Life, lifestyle and socioeconomic status [Time Frame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years]

Comparison in the computer tomography angiography and invasive coronary angiography group: Rates of patients undergoing further cardiac diagnostics [Time Frame: 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]

Correlation of effective dose and the diagnostic portion of Invasive Coronary Angiography with weight and body-mass index of the patient. [Time Frame: during the Invasive Coronary Angiography examination, at 1-year follow-up and at final follow-up to a maximum of 4 years]

Health related Quality of Life and Lifestyle [Time Frame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years]

Pragmatic assessment of staff involvement time and material use - completion of questionnaires [Time Frame: up to a maximum of 2 years after completion of pilot study at all sites]

Gender differences in examination results [Time Frame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years]

Heart rate reduction achieved in Computed Tomography by the DISCHARGE betablocker protocol [Time Frame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial]

Comparison of cumulative contrast agent amount in the two arms [Time Frame: 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]

Heart rate reduction achieved in subgroups [Time Frame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial]

Gender differences of structural Computed Tomography Angiography findings [Time Frame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years]

Gender differences regarding all aspects of medical history [Time Frame: : at baseline, at 1-year follow-up and final follow-up to a max of 4 years]

Qualitative analysis [Time Frame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial]

Occurrence of other adverse events and serious adverse events in the Invasive Coronary Angiography group [Time Frame: during the procedure or within 48 hours post last related procedure]

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. [Time Frame: at 1-year follow-up and final follow-up to a maximum of 4 years]

Rates of contrast-induced nephropathy [Time Frame: up to 48h after hours after the final procedure related to the test randomised to]

Rates of percutaneous coronary intervention and use of intracoronary techniques different European countries [Time Frame: at baseline, 1-year follow-up and final follow-up up to a max of 4 years]

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 [Time Frame: 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]

Occurrence of adverse events related to venous or arterial puncture [Time Frame: during the procedure or within 48 hours post last related procedure]

Time from randomisation to Invasive Coronary Angiography in both groups [Time Frame: at 1-year follow-up and final follow-up to a max of 4 years]

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 [Time Frame: at 1-year follow-up and final follow-up to a maximum of 4 years]

Infections [Time Frame: during the procedure or within 48 hours post last related procedure]

Influence of experience of examiners on events [Time Frame: during the procedure or within 48 hours post last related procedure]

Rates of planned cross-over from Computed Tomography to Invasive Coronary Angiography [Time Frame: 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]

Major Adverse Cardiac Events in different composites [Time Frame: at baseline, at 1-year follow-up and final follow up to a max of 4 years]

Influence of statin treatment on plaque development [Time Frame: during the Computed Tomography examination and up to 6 months after the pragmatic Randomised Controlled Trial]

Occurrence of cardiac arrhythmia [Time Frame: during the procedure or within 48 hours post last related procedure]

Potential advantage of the DISCHARGE and COME-CCT calculators [Time Frame: at 1-year follow-up and final follow-up to a maximum of 4 years]

Noise in Computed Tomography Angiography imaging [Time Frame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial]

Time from randomisation to first coronary revascularisation in both groups [Time Frame: at 1-year follow-up and final follow-up to a max of 4 years]

Reduction of radiation exposure by using coronary artery calcium score information [Time Frame: 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]

Relation of plaque characterisation and quantification by core lab and Major and Minor Adverse Cardiac Events at the two follow-up results [Time Frame: at 1-year follow-up and final follow-up to a maximum of 4 years]

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) [Time Frame: at 1-year follow-up and final follow-up to a max of 4 years]

Predictive value of the DISCHARGE calculator [Time Frame: at 1-year follow-up and final follow-up to a max of 4 years]

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%) [Time Frame: at 1-year follow-up and final follow-up to a max of 4 years]

Semi-qualitative analysis [Time Frame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial]

Prevalence of left, intermediate, and right coronary distribution type [Time Frame: 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]

Validation of the coronary artery disease DISCHARGE and COME-CCT pre-test probability calculators [Time Frame: at 1-year follow-up and final follow-up to a maximum of 4 years]

Correlation of intensity and reduction of angina pectoris [Time Frame: at baseline, at 1-year follow-up and final follow-up to a maximum of 4 years]

Procedural complications during or after revascularisation [Time Frame: during the procedure or within 48 hours post last related procedure]

Correlation of the number of projections for the right and left coronary artery with effective dose of Invasive Coronary Angiography [Time Frame: during the Invasive Coronary Angiography examination, at 1-year follow-up and at final follow-up to a maximum of 4 years]

European and local differences in patient consent of sites [Time Frame: at baseline, 1-year follow-up and final follow-up up to a max of 4 years]

Validation of different questionnaires to predict Major and Minor Adverse Cardiac Events [Time Frame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years]

Extent of Coronary Artery Disease [Time Frame: at 1-year follow-up and final follow-up to a max of 4 years]

Follow-up strategies in different European countries [Time Frame: at baseline, 1-year follow-up and final follow-up up to a max of 4 years]

Gender differences of coronary plaque characteristics determined by Computed Tomography [Time Frame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years]

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 [Time Frame: at 1-year follow-up and final follow-up to a max of 4 years]

Procedural complications related to Invasive Coronary Angiography [Time Frame: during the procedure or within 48 hours post last related procedure]

Reduction of angina pectoris intensity [Time Frame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years]

Ability of the DISCHARGE and COME-CCT calculators to predict Major and Minor Adverse Cardiac Events [Time Frame: at 1-year follow-up and final follow-up to a maximum of 4 years]

Characterisation of plaques [Time Frame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial]

Comparison in the Computed Tomography Angiography and Invasive coronary Angiography group: Percutaneous Coronary Intervention and Coronary Artery Bypass Graft [Time Frame: 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]

Comparison in the computer tomography angiography and invasive coronary angiography group: Rates of coronary interventions [Time Frame: 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]

Comparison in the Computer Tomography Angiography and Invasive Coronary Angiography group: Rates of patients on dialysis [Time Frame: 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]

Comparison of imaging ischemia results with Computed Tomography Angiography and Invasive Coronary Angiography results for prediction of Major and Minor Cardiac Adverse Events [Time Frame: 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]

Correlation of effective dose of and contrast agent amount used for Invasive Coronary Angiography with severity of Coronary Artery Disease [Time Frame: during the Invasive Coronary Angiography examination, at 1-year follow-up and at final follow-up to a maximum of 4 years]

Differences in staff involvement time for Computed Tomography Angiography and Invasive Coronary Angiography in different clinical sites [Time Frame: up to a maximum of 2 years after completion of pilot study at all sites]

Gender differences in radiation exposure and gender [Time Frame: at baseline, at 1-year follow-up and final follow-up to a max of 4 years]

Heart rate reduction achieved with conscious sedation, if used, for Computed Tomography [Time Frame: during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial]

Likelihood of receiving coronary intervention in different European countries [Time Frame: at baseline, 1-year follow-up and final follow-up up to a max of 4 years]

Occurrence of adverse events due to medication [Time Frame: during the procedure or within 48 hours post last related procedure]

Occurrence of procedural events in imaging ischemia testing [Time Frame: at baseline, at 1-year follow-up and final follow-up to a maximum of 4 years]

Patient acceptance of informed consent, preparation and procedural aspects of the test performed [Time Frame: 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]

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 [Time Frame: during the Invasive Coronary Angiography examination, at 1-year follow-up and at final follow-up to a maximum of 4 years]

Secondary ID(s)

Z 5 - 22462/2 - 2014-001

EC-GA 603266

EA1/294/13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors