PROMISE Trial: Dx Core

PROMISE 试用版：Dx Core

• 批准号: 7940903
• 负责人: UDO HOFFMANN
• 金额: $ 110.48万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7940903
• 关键词: Address; Adoption; American; American College of Radiology Imaging Network; Anatomy; Ancillary Study; Angiography; Archives; Benchmarking; Cardiac; Caregivers; Caring; Certification; Cessation of life; Chest Pain; Clinical; Clinical Data; Clinical Practice Guideline; Clinical Trials; Clinical Trials Design; Coronary; Coronary Arteriosclerosis; Coronary artery; Coronary heart disease; Data; Data Coordinating Center; Development; Diagnostic; Diagnostic tests; Echocardiography; Economics; Education; Electrocardiogram; Enrollment; Ensure; Evaluation Studies; Event; Exercise; Faculty; Feedback; Funding; Goals; Health; Health Care Costs; Health Policy; Heart Diseases; Hospitalization; Image; Industry; Information Technology; Lead; Leadership; Measures; Medical; Modality; Myocardial Infarction; Nuclear; Outcome; Patients; Performance; Physicians; Protocols documentation; Quality of life; Randomized; Reader; Recommendation; Relative (related person); Reporting; Research Personnel; Resources; Risk; Role; Services; Shapes; Site; Stress; Stress Tests; Symptoms; System; Testing; Therapeutic; United States National Institutes of Health; Unstable angina; Variant; arm; base; clinical application; clinical practice; clinical research site; cost; cost effectiveness; data management; effectiveness trial; experience; follow-up; health related quality of life; improved; medical specialties; new technology; performance tests; pragmatic trial; programs; prospective; public health relevance; quality assurance; randomized trial; response; transmission process; treatment as usual

DESCRIPTION (provided by applicant): Millions of Americans develop chest pain suggestive of coronary heart disease each year and often require non-invasive diagnostic testing. However, currently available tests are imprecise, robust evidence regarding optimal test choice is limited, and testing costs are rising disproportionately. Further, the role of new technology such as coronary computed tomographic angiography (CTA) is uncertain. In response, the "PROspective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE)" Trial will test the hypothesis that an initial 'anatomic' testing strategy (using CTA) is clinically superior to usual care or an initial 'functional' stress testing strategy (using physician-selected stress imaging (echocardiography or nuclear) or exercise electrocardiography)) in low-intermediate coronary artery risk patients with chest pain, and will reduce the composite primary endpoint of death, myocardial infarction, major peri-procedural complications and hospitalization for unstable angina. This 150 site pragmatic trial will randomize 10,000 symptomatic patients with clinically determined, low-intermediate risk for CAD over 24 months. All subsequent diagnostic and therapeutic management will be based on the latest clinical practice guideline recommendations and will be at the discretion of the treating care team. Patients will be followed for up to 48 months (median 2.5 years). The trial design is carefully constructed to ensure the broadest possible applicability of results by incorporating the full spectrum of practice settings, caregiver specialties, and types of tests which are immediately relevant to the clinical decisions needed to care for the vast majority of chest pain patients nationwide. Projecting a 9% event rate in the functional testing or usual care arm, enrollment of 5,000 patients in each testing arm will provide 90% power for detecting a 20% relative reduction in the composite primary endpoint. Secondary endpoints include components of the primary endpoint as well as 1) medical costs, resource utilization, cost effectiveness; 2) health related quality of life. This proposal includes the lead Clinical Coordinating Center (CCC; Pamela S Douglas, PI), a Statistical and Data Coordinating Center (SDCC; Kerry L Lee, PI), an Economics and Quality of Life (EQOL; Daniel B Mark, PI), and a Diagnostic Test Core (Dx Core; Udo Hoffmann, PI). This experienced multi-speciality team will deliver the integrated services vital to PROMISE trial, including faculty and operational leadership, imaging and testing expertise, site management, patient follow up, statistical analysis and data management. Although costs of care are extremely important, only demonstration of clinical superiority in real-world settings will change practice or justify use and reimbursement of a new technology such as CTA. PROMISE, as the first large randomized comparison of two diagnostic testing strategies for patients with suspected CAD, will provide the critical evidence regarding clinical outcomes and costs of alternative approaches necessary to shape clinical practice recommendations and health care policy in patients with chest pain for years to come. PUBLIC HEALTH RELEVANCE: Project narrative The PROMISE ("PROspective Multicenter Imaging Study for Evaluation of Chest Pain) Trial is a 10,000 patient multicenter, randomized trial which will identify the best diagnostic approach for people with chest pain and suspected heart disease. It will determine whether coronary computed tomographic angiography (CTA) is superior to usual cardiac stress testing in improving subsequent health outcomes and reducing medical costs for up to 4 years. By determining the impact of diagnostic testing on patient health, PROMISE's results will define care and shape health policy for the millions of symptomatic people referred for stress testing each year, determine the value of stunning new technologic advances such as CTA, and address rising health care costs.

描述（由申请人提供）：数以百万计的美国人每年出现冠状动脉疾病的胸痛，通常需要非侵入性诊断测试。但是，目前可用的测试是不精确的，有关最佳测试选择的有限证据是有限的，并且测试成本不成比例地上升。此外，尚不确定新技术（例如冠状动脉层析造影术（CTA））的作用尚不确定。 In response, the "PROspective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE)" Trial will test the hypothesis that an initial 'anatomic' testing strategy (using CTA) is clinically superior to usual care or an initial 'functional' stress testing strategy (using physician-selected stress imaging (echocardiography or nuclear) or exercise electrocardiography)) in low-intermediate coronary artery risk patients with chest pain, and will reduce复合的主要终点，心肌梗塞，主要的围外并发症和不稳定心绞痛的住院治疗。这项150个现场务实的试验将在24个月内随机分配10,000例有临床确定的CAD中中间风险的症状患者。随后的所有诊断和治疗管理将基于最新的临床实践指南建议，并由治疗护理团队酌情决定。患者最多将遵循48个月（中值2。5年）。仔细构建了试验设计，以确保结果的最广泛适用性，通过纳入与全国绝大多数胸痛患者所需的临床决策有关的全部练习环境，护理人员专业和测试类型。在功能测试或常规护理机构中预测9％的事件率，在每个测试臂中注册5,000名患者将提供90％的功率，以检测复合材料主终点的相对降低20％。次要终点包括主要终点的组成部分以及1）医疗费用，资源利用，成本效益； 2）与健康相关的生活质量。 该建议包括统计和数据协调中心（SDCC； Kerry L Lee，PI）的铅临床协调中心（CCC； Pamela S Douglas，PI），经济学和生活质量（EQOL; Daniel B Mark，PI），以及DX Core（DX Core; DX Core; DX Core; udo Hoffmann，pi; Udo Hoffmann，pi）。这个经验丰富的多专科团队将提供对承诺试验至关重要的综合服务，包括教职员工和运营领导，成像和测试专业知识，现场管理，患者随访，统计分析和数据管理。 尽管护理成本极为重要，但仅在现实世界中证明临床优势才能改变实践或证明使用和报销新技术（例如CTA）。承诺作为对可疑CAD患者的两种诊断测试策略进行的第一个大型随机比较，将为临床结果和成本提供关键证据，以塑造未来几年的胸痛患者的临床实践建议和医疗保健政策所需的替代方法。 公共卫生相关性：项目叙事（“用于评估胸痛的前瞻性多中心成像研究）试验是一项10,000例患者多中心，随机试验，它将确定针对患有胸痛的人和怀疑心脏病的人的最佳诊断方法。它将确定冠状动脉计算机术血管造影术（CTA）是否优于改善次要的医疗效果，以改善4年的临时效果，并改善了4年的临时效果，并改善了4年的临时效果，并改善了4年的临界。在对患者健康的诊断测试中，Promise的结果将为每年参考压力测试的数百万症状人士的护理和塑造健康政策，确定令人惊叹的新技术进步的价值，例如CTA，并解决日益增长的医疗保健费用。