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临床试验/NCT02400229
NCT02400229已完成不适用

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

Charite University, Berlin, Germany40 个研究点 分布在 15 个国家目标入组 3,546 人开始时间: 2015年10月3日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,546
试验地点
40
主要终点
Major Adverse Cardiovascular Event
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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)

结局指标

主要结局

Major Adverse Cardiovascular Event

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

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

次要结局

  • 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)
  • European and local differences in patient consent of sites(at baseline, 1-year follow-up and final follow-up up to a max of 4 years)
  • Analysis of the influence of prior computer tomography angiography on invasive coronary angiography and percutaneous coronary intervention(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)
  • Time from randomisation to Invasive Coronary Angiography in both groups(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: procedures and outcomes in relation to age(at 1-year follow-up and final follow-up to a max 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(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)
  • Follow-up strategies in different European countries(at baseline, 1-year follow-up and final follow-up up to a max of 4 years)
  • Comparison in the Computer Tomography Angiography and Invasive Coronary Angiography group: Rate of coronary anatomical anomalies(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 cumulative contrast agent amount in the two arms(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: Distribution in the mode of revascularization: percutaneous coronary intervention vs. coronary artery bypass graft(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)
  • Validation of different questionnaires to predict Major and Minor Adverse Cardiac Events(at baseline, at 1-year follow-up and final follow-up to a max of 4 years)
  • Procedural complications related to Invasive Coronary Angiography(during the procedure or within 48 hours post last related procedure)
  • 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)
  • Patient management in different European countries(at baseline, 1-year follow-up and final follow-up up to a max of 4 years)
  • Extent of Coronary Artery Disease(at 1-year follow-up and final follow-up to a max of 4 years)
  • Time from randomisation to first coronary revascularisation in both groups(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: procedures and outcomes in relation to body mass index and obesity(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(during the procedure or within 48 hours post last related procedure)
  • Rates of contrast-induced nephropathy(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(at baseline, 1-year follow-up and final follow-up up to a max of 4 years)
  • Comparison in the Coronary Computed Tomographic Angiography and Invasive Coronary Angiography group:Occurrence of Minor Adverse Cardiovascular Events(1 minute after randomisation to CT/ICA diagnostic procedure and during follow-up)
  • Comparison in the computer tomography angiography and invasive coronary angiography group: Rates of patients undergoing further cardiac diagnostics(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(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 Quality of Life between treatment regimens.(at 1-year follow-up and final follow-up to a max of 4 years)
  • Occurrence of adverse events due to medication(during the procedure or within 48 hours post last related procedure)
  • Occurrence of cardiac arrhythmia(during the procedure or within 48 hours post last related procedure)
  • Influence of experience of examiners on events(during the procedure or within 48 hours post last related procedure)
  • 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(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 incidental findings in Computed Tomography Angiography and Invasive Coronary Angiography group and potential benefits and harms of findings(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 in the Computed Tomography Angiography and Invasive coronary Angiography group: Percutaneous Coronary Intervention and Coronary Artery Bypass Graft(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 patients on dialysis(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(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)
  • Geographical distribution of risk factors for Major Cardiovascular Events and Minor Cardiovascular Events and other events(at 1-year follow-up and final follow-up to a max 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)(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(at 1-year follow-up and final follow-up to a max of 4 years)
  • Reduction of angina pectoris intensity(at baseline, at 1-year follow-up and final follow-up to a max of 4 years)
  • Infections(during the procedure or within 48 hours post last related procedure)
  • Comparison of occurrence of procedural complications related to Invasive Coronary Angiography(during the procedure or within 48 hours post last related procedure)
  • Procedural complications during or after revascularisation(during the procedure or within 48 hours post last related procedure)
  • 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(at 1-year follow-up and final follow-up to a maximum of 4 years)
  • Coronary artery dimensions(during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial)
  • Heart rate reduction achieved in subgroups(during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial)
  • Comparison of diagnostic accuracy of imaging ischemia tests(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 between imaging ischemia results and coronary stenosis as well as plaque composition and characterisation findings by Computed Tomography Angiography(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)
  • Occurrence of procedural events in imaging ischemia testing(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(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 radiation dose in Invasive Coronary Angiography and Computed Tomography Angiography: pilot study versus non-study patients(during Computed Tomography Angiography and Invasive Coronary Angiography Examination)
  • Occurrence of other adverse events and serious adverse events in the Invasive Coronary Angiography group(during the procedure or within 48 hours post last related procedure)
  • Analysis of interobserver variability (site versus core lab)(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(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)
  • 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.(at 1-year follow-up and final follow-up to a maximum of 4 years)
  • Image quality of Computed Tomography by core lab read and flow and concentration of contrast agent used intravenously(during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial)
  • Accuracy and agreement of RCADIA system(during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial)
  • Correlation of extent of Coronary Artery Disease and a high calcium score(during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial)
  • 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(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(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)
  • Relation of plaque characterisation and quantification by core lab and Major and Minor Adverse Cardiac Events at the two follow-up results(at 1-year follow-up and final follow-up to a maximum of 4 years)
  • Noise in Computed Tomography Angiography imaging(during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial)
  • 10-step Guide to cardiac CT(during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial)
  • Semi-qualitative analysis(during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial)
  • Heart rate reduction achieved in Computed Tomography by the DISCHARGE betablocker protocol(during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial)
  • Characterisation of plaques(during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial)
  • Differences in plaque characteristics(during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial)
  • Rates of left ventriculography performed(during the Invasive Coronary Angiography examination, at 1-year follow-up and at final follow-up to a maximum of 4 years)
  • Rates of planned cross-over from Computed Tomography to Invasive Coronary Angiography(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 Computed Tomography Angiography and Invasive Coronary Angiography group and potential benefits and harms of findings:Rates of unnecessary follow-up procedures(at 1-year follow-up and final follow-up to a maximum of 4 years)
  • Prevalence of sinus node artery being a side branch of Left Coronary Artery or Right Coronary Artery(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 Computed Tomography Angiography and intracoronary techniques(during the Computed Tomography examination and up to 6 months after the pragmatic Randomised Controlled Trial)
  • Reduction of radiation exposure by using coronary artery calcium score information(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)
  • Differences in staff involvement time for Computed Tomography Angiography and Invasive Coronary Angiography in different clinical sites(up to a maximum of 2 years after completion of pilot study at all sites)
  • Comparison of population of pilot study between the different European clinical sites(up to a maximum of 2 years after completion of pilot study at all sites)
  • 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(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)
  • Prevalence of left, intermediate, and right coronary distribution type(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)
  • Factors that influence the image quality of Computed Tomography Angiography(during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial)
  • Qualitative analysis(during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial)
  • Heart rate reduction achieved with conscious sedation, if used, for Computed Tomography(during the Computed Tomography examination and up to 6 months after the Pragmatic Randomised Controlled Trial)
  • Influence of statin treatment on plaque development(during the Computed Tomography examination and up to 6 months after the pragmatic Randomised Controlled Trial)
  • Correlation of effective dose and the diagnostic portion of Invasive Coronary Angiography with weight and body-mass index of the patient.(during the Invasive Coronary Angiography examination, at 1-year follow-up and at final follow-up to a maximum 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(during the Invasive Coronary Angiography examination, at 1-year follow-up and at 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(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(during the Invasive Coronary Angiography examination, at 1-year follow-up and at final follow-up to a maximum of 4 years)
  • Correlation of the number of projections for the right and left coronary artery with effective dose of Invasive Coronary Angiography(during the Invasive Coronary Angiography examination, at 1-year follow-up and at final follow-up to a maximum of 4 years)
  • Rates of imaging ischemia tests recommended(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)
  • 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(at baseline, at 1-year follow-up and final follow-up to a maximum of 4 years)
  • Potential advantage of the DISCHARGE and COME-CCT calculators(at 1-year follow-up and final follow-up to a maximum of 4 years)
  • Predictive value of the DISCHARGE calculator(at 1-year follow-up and final follow-up to a max of 4 years)
  • Cost-Effectiveness Analysis(at 1-year follow-up and final follow-up to a max of 4 years)
  • Comparison of cost-effectiveness analysis and cost-utility analysis in different European countries(at 1-year follow-up and final follow-up to a max of 4 years)
  • Additional treatments during follow-up by clinical site(at 1-year follow-up and final follow-up to a max of 4 years)
  • Acceptance of time trade-off question in the pilot study(at baseline, at 1-year follow-up and final follow-up to a max of 4 years)
  • Gender differences in radiation exposure and gender(at baseline, at 1-year follow-up and final follow-up to a max of 4 years)
  • Gender differences in examination results(at baseline, at 1-year follow-up and final follow-up to a max of 4 years)
  • Correlation of Computed Tomography Angiography and/or Invasive Coronary Angiography with the results of imaging ischemia tests(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 between imaging ischemia tests and invasive Fractional Flow Reserve if done(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)
  • Analysis of patient acceptance ("preference questionnaire") of Computed Tomography Angiography and Invasive Coronary Angiography(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)
  • Ability of the DISCHARGE and COME-CCT pre-test probability calculators to predict Coronary Artery Disease(at 1-year follow-up and final follow-up to a maximum of 4 years)
  • Pragmatic assessment of staff involvement time and material use - completion of questionnaires(up to a maximum of 2 years after completion of pilot study at all sites)
  • Correlation of previous cardiac examination results of patients included in the pilot study with result of Computed Tomography Angiography and Invasive Coronary Angiography(up to a maximum of 2 years after completion of pilot study at all sites)
  • Health related Quality of Life and Lifestyle(at baseline, at 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(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 the results of study- Computed Tomography Angiography, recommended imaging ischemia test and Invasive Coronary Angiography in patients with respective study course(at baseline, at 1-year follow-up and final follow-up to a maximum of 4 years)
  • Correlation of intensity and reduction of angina pectoris(at baseline, at 1-year follow-up and final follow-up to a maximum of 4 years)
  • Effective radiation dose for Computed Tomography Angiography and Invasive Coronary Angiography(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)
  • Validation of the coronary artery disease DISCHARGE and COME-CCT pre-test probability calculators(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(at 1-year follow-up and final follow-up to a maximum 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%)(at 1-year follow-up and final follow-up to a max of 4 years)
  • Days in hospital per patient by clinical site during follow up(at 1-year follow-up and final follow-up to a max of 4 years)
  • Development and validation of a novel pre-test probability calculator(at 1-year follow-up and final follow-up to a maximum of 4 years)
  • Ability of the DISCHARGE and COME-CCT calculators to predict Major and Minor Adverse Cardiac Events(at 1-year follow-up and final follow-up to a maximum of 4 years)
  • Cost-Utility Analysis(at 1-year follow-up and final follow-up to a max of 4 years)
  • Average days off work per patient by clinical site during follow up(at 1-year follow-up and final follow-up to a max of 4 years)
  • Differences in consumption of materials in different clinical sites(up to a maximum of 2 years after completion of pilot study at all sites)
  • Comparison of hospitalisation after Invasive Coronary Angiography in different European clinical sites(up to a maximum of 2 years after completion of pilot study at all sites)
  • Gender differences regarding Quality of Life, lifestyle and socioeconomic status(at baseline, at 1-year follow-up and final follow-up to a max of 4 years)
  • Gender differences of pulmonary findings of Computed Tomography Angiography(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(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(up to a maximum of 2 years after completion of pilot study at all sites)
  • Comparison of the health instruments(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(: at baseline, at 1-year follow-up and final follow-up to a max of 4 years)
  • Gender differences of myocardial resting blood flow / tissue characteristics determined by Computed Tomography Angiography(at baseline, at 1-year follow-up and final follow-up to a max of 4 years)
  • Major Adverse Cardiac Events in different composites(at baseline, at 1-year follow-up and final follow up to a max of 4 years)
  • Occurrence of Myocardial Infarction and stroke(at baseline, 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(up to a maximum of 2 years after completion of pilot study at all sites)
  • Gender differences of coronary plaque characteristics determined by Computed Tomography(at baseline, 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(at baseline, at 1-year follow-up and final follow-up to a max of 4 years)
  • Gender differences of structural Computed Tomography Angiography findings(at baseline, 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(at baseline, at 1-year follow-up and final follow up to a max of 4 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marc Dewey

Professor

Charite University, Berlin, Germany

研究点 (40)

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