PROMISE Trial: Substudy to Assess for Effective Dose of Radiation

PROMISE 试验：评估有效辐射剂量的子研究

• 批准号: 8507272
• 负责人: Andrew Einstein
• 金额: $ 44.88万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8507272
• 关键词: Academy; Accounting; American; Anatomy; Angiography; Area; Benefits and Risks; Binding Sites; Cardiac; Cardiac Catheterization Procedures; Cardiovascular system; Caring; Chest; Chest Pain; Computerized Medical Record; Coronary; Coronary Angiography; Coronary Arteriosclerosis; Data; Diagnostic tests; Dose; Echocardiography; Electrocardiogram; Ethnic Origin; Evaluation; Evaluation Studies; Event; Exposure to; Fluoroscopy; Functional Imaging; Gender; Gold; Guidelines; Health Maintenance Organizations; Health Policy; Image; Imaging Techniques; Incidence; Incidental Findings; Ionizing radiation; Length; Lung nodule; Measurement; Measures; Methodology; Methods; Modeling; Myocardial perfusion; Outcome Measure; Patients; Physicians; Population; Predictive Factor; Probability; Procedures; Protocols documentation; Race; Radiation; Radiometry; Radionuclide Imaging; Records; Registries; Risk; Shapes; Site; Slice; Societies; Stress; Stress Tests; Surveys; Testing; Time; Weight; X-Ray Computed Tomography; base; cancer risk; cost; design; disorder risk; dosimetry; evaluation/testing; follow-up; improved; primary outcome; prospective; radiation detector; simulation; solid state; treatment as usual

DESCRIPTION (provided by applicant): Millions of Americans develop chest pain suggestive of coronary artery disease (CAD) each year and often receive non-invasive diagnostic testing such as myocardial perfusion scintigraphy (MPS) or, more recently, coronary computed tomographic angiography (CCTA). Such testing accounts for ~10% of the entire ionizing radiation burden to the U.S. population. The 200-site, 10,000 patient "PROspective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE)" Trial is testing the hypothesis that an initial 'anatomic' (CCTA) testing strategy is superior in reducing major adverse cardiovascular events to usual care with an initial 'functional' stress testing strategy (using physician-selected stress imaging (MPS or echocardiography) or stress electrocardiography)) in low-intermediate CAD risk patients with chest pain. However, comprehensive comparison of testing strategies requires accurate assessment not just of cardiovascular events, but also weighting these against costs and risks for each strategy. The objective of this ancillary "PROMISE Substudy to Assess For Effective dose of Radiation (PROMISE-SAFER)" is to compare the radiation burden of initial anatomic vs. functional testing strategies for the evaluation of suspected CAD. Its primary aim is to determine whether cumulative radiation dose to symptomatic patients is decreased with an anatomic imaging strategy as compared to a functional testing strategy. While PROMISE will record basic measures of radiation burden from initial CCTA and MPS exams, the proposed study will develop a more accurate and comprehensive approach that is needed to accurately compare patients' cumulative radiation effective doses between testing strategies. This will include tracking subsequent tests for CAD evaluation and tests to evaluate incidental findings such as pulmonary nodules, and measured or imputed patient-specific dosimetry estimates from each follow-up test, with imputation performed using data from a large dose registry. Moreover, accurate estimation of radiation effective dose in CCTA will require determination of new conversion factors for contemporary CT scanners, to be performed using measurements obtained using solid-state radiation detectors in physical anthropomorphic phantoms. Additional aims are to compare projected cumulative lifetime attributable risk of cancer incidence, as determined using radioepidemiological models developed by the National Academies, between testing strategies, and to characterize the variability of radiation doses of cardiac imaging procedures, identifying patient, strategy, site, and regional factors predictive of high dose and repeated testing.

描述（由申请人提供）：