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提示冠心病的胸痛，通常需要非侵入性诊断测试。然而，目前可用的测试并不精确，关于最佳测试选择的有力证据有限，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学研究（PROMISE）”试验将验证这样一种假设，即在中低冠状动脉风险胸痛患者中，初始“解剖”测试策略（使用CTA）在临床上优于常规护理或初始“功能性”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），并将降低复合主要死亡终点。不稳定型心绞痛的心肌梗死、主要围手术期并发症及住院治疗。这项150个地点的实用试验将随机抽取10000名临床确定的有症状的、中低风险的冠心病患者，时间超过24个月。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自行决定。患者将被随访长达48个月（中位2.5年）。试验设计是精心构建的，以确保结果的最广泛的适用性，通过纳入全谱的实践设置，护理人员的专业和类型的测试，这些测试与全国绝大多数胸痛患者护理所需的临床决策直接相关。在功能试验或常规护理组中，预计9%的事件发生率，每个试验组入组5000例患者将提供90%的能力来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)医疗费用、资源利用、成本效益；2)与健康相关的生活质量。