PROMISE Trial: Clinical Coordinating Center

PROMISE 试验：临床协调中心

• 批准号: 7768791
• 负责人: Pamela Susan Douglas
• 金额: $ 556.65万
• 依托单位: DUKE UNIVERSITY
• 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 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7768791
• 关键词: Accident and Emergency department; Accounting; Address; Adoption; American; Anatomy; Angiography; Arts; Cardiac; Caregivers; Caring; Cause of Death; Cessation of life; Chest Pain; Clinical; Clinical Practice Guideline; Clinical Research; Clinical Trials; Clinical Trials Design; Conflict (Psychology); Coronary; Coronary Arteriosclerosis; Coronary artery; Coronary heart disease; Data Coordinating Center; Diagnostic; Diagnostic tests; Echocardiography; Economics; Electrocardiogram; Enrollment; Ensure; Equipoise; Evaluation Studies; Event; Evidence Based Medicine; Exercise; Faculty; Health; Health Care Costs; Health Policy; Heart Diseases; Hemorrhage; Home environment; Hospitalization; Image; Kidney Failure; Laboratories; Lead; Leadership; Medical; Myocardial Infarction; Myocardial Ischemia; National Heart, Lung, and Blood Institute; Nuclear; Outcome; Patients; Physicians; Physicians' Offices; Practice Guidelines; Quality of life; Randomized; Randomized Controlled Clinical Trials; Recommendation; Relative (related person); Research; Research Institute; Research Personnel; Resources; Risk; Role; Services; Shapes; Site; Slice; Stress; Stress Tests; Stroke; Test Result; Testing; Therapeutic; Uncertainty; Unstable angina; Upper arm; Visit; base; clinical practice; cost; cost effectiveness; data management; economic outcome; experience; follow-up; health related quality of life; improved; medical specialties; new technology; pragmatic trial; prospective; public health relevance; response; statistical center; statistics; treatment as usual; trial comparing

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胸痛，提示患有冠心病，通常需要进行非侵入性诊断测试。然而，目前可用的测试并不准确，关于最佳测试选择的有力证据有限，测试成本正在不成比例地上升。此外，冠状动脉计算机断层血管成像(CTA)等新技术的作用尚不确定。对此，“评估胸痛的前瞻性多中心影像研究(Promise)”试验将检验这一假设，即在有胸痛的中低度冠状动脉风险患者中，初始“解剖”测试策略(使用CTA)在临床上优于常规治疗或初始“功能性”负荷测试策略(使用医生选择的负荷成像(超声心动图或核心动图)或运动心电图)，并将降低死亡、心肌梗死、围术期主要并发症和不稳定型心绞痛住院的综合主要终点。这项150个地点的务实试验将随机选择10,000名临床确定的、在24个月内罹患冠心病的中低风险患者。所有后续的诊断和治疗管理将基于最新的临床实践指南建议，并将由治疗护理团队酌情决定。患者将接受长达48个月的随访(中位数为2.5年)。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系列实践环境、护理人员专业知识和测试类型，确保结果具有最广泛的适用性。预计功能测试或常规护理分支的事件发生率为9%，在每个测试分支中登记5000名患者将提供90%的功率，以检测复合主要终点相对减少20%。次要终点包括主要终点的组成部分以及1)医疗成本、资源利用、成本效益；2)与健康相关的生活质量。 这项提议包括首席临床协调中心(首席临床协调中心；帕梅拉·S·道格拉斯，PI)、统计和数据协调中心(SDCC；克里·L·李，PI)、经济和生活质量协调中心(EQOL；丹尼尔·B·马克，PI)和诊断测试核心(Dx Core；Udo Hoffmann，PI)。这支经验丰富的多专业团队将提供对Promise Trial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，但只有在现实世界中证明临床优势才能改变实践，或者证明CTA等新技术的使用和补偿是合理的。作为对疑似冠心病患者的两种诊断测试策略的首次大规模随机比较，Promise将提供关于临床结果和替代方法成本的关键证据，这些方法是在未来几年为胸痛患者制定临床实践建议和医疗保健政策所必需的。 公共卫生相关性：项目The Promise(“用于评估胸痛的前瞻性多中心成像研究”)试验是一项10,000名患者的多中心随机试验，将确定胸痛和疑似心脏病患者的最佳诊断方法。它将确定冠状动脉CT血管造影术(CTA)在改善后续健康结果和降低长达4年的医疗成本方面是否优于常规的心脏负荷测试。通过确定诊断测试对患者健康的影响，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医疗政策，确定CTA等令人震惊的新技术进步的价值，并解决不断上涨的医疗成本。