PROMISE Trial: Dx Core

PROMISE 试用版：Dx Core

基本信息

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
项目类别：
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

项目摘要

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）：每年有数百万美国人出现提示冠心病的胸痛，并且通常需要非侵入性诊断测试。然而，目前可用的测试不精确，有关最佳测试选择的有力证据有限，并且测试成本不成比例地上升。此外，冠状动脉计算机断层血管造影（CTA）等新技术的作用尚不确定。作为回应，“评估胸痛的前瞻性多中心影像研究 (PROMISE)”试验将检验以下假设：初始“解剖”测试策略（使用 CTA）在临床上优于常规护理或初始“功能”压力测试策略（使用医生选择的压力成像（超声心动图或核）或运动心电图））在低中冠状动脉风险的胸痛患者中进行，并将减少死亡、心肌梗塞等复合主要终点梗塞、主要围手术期并发症和不稳定心绞痛住院。这项 150 个中心的实用试验将在 24 个月内随机抽取 10,000 名有症状的患者，这些患者经临床确定患有 CAD 的中低风险。所有后续的诊断和治疗管理都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。患者将接受长达 48 个月（中位 2.5 年）的随访。试验设计经过精心设计，通过纳入与护理全国绝大多数胸痛患者所需的临床决策直接相关的全方位实践环境、护理人员专业和测试类型，确保结果具有最广泛的适用性。预计功能测试或常规护理组的事件率为 9%，每个测试组招募 5,000 名患者将为检测复合主要终点相对减少 20% 提供 90% 的功效。次要终点包括主要终点的组成部分以及 1) 医疗费用、资源利用率、成本效益； 2）与健康相关的生活质量。该提案包括牵头的临床协调中心（CCC；Pamela S Douglas，PI）、统计和数据协调中心（SDCC；Kerry L Lee，PI）、经济学和生活质量中心（EQOL；Daniel B Mark，PI）、和诊断测试核心（Dx Core；Udo Hoffmann，PI）。这个经验丰富的多专业团队将提供对 PROMISE 试验至关重要的综合服务，包括教师和运营领导、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。尽管护理成本极其重要，但只有在现实环境中证明临床优越性才能改变实践或证明 CTA 等新技术的使用和报销是合理的。 PROMISE 是对疑似 CAD 患者的两种诊断测试策略进行的首次大规模随机比较，将提供有关临床结果和替代方法成本的关键证据，以制定多年来胸痛患者的临床实践建议和医疗保健政策来。公共健康相关性：项目叙述 PROMISE（“评估胸痛的前瞻性多中心影像研究”）试验是一项 10,000 名患者的多中心随机试验，将为胸痛和疑似心脏病患者确定最佳诊断方法。它将确定是否通过确定诊断测试对患者的影响，冠状动脉计算机断层扫描血管造影 (CTA) 在改善后续健康结果和降低医疗费用方面优于常规心脏负荷测试。 PROMISE 的结果将为每年接受压力测试的数百万有症状的人定义护理和制定健康政策，确定 CTA 等令人惊叹的新技术进步的价值，并解决不断上涨的医疗保健成本问题。