PROMISE Trial: EQOL Coordinating Center

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，目前可用的测试是不精确的，关于最佳测试选择的有力证据是有限的，测试成本不成比例地上升。此外，冠状动脉计算机断层扫描血管造影（CTA）等新技术的作用尚不确定。作为回应，“前瞻性多中心影像学研究评价胸痛（PROMISE）”试验将测试假设，（使用CTA）在临床上上级常规护理或初始“功能”压力测试策略（使用医生选择的负荷成像（超声心动图或核）或运动心电图））在低中度冠状动脉风险胸痛患者中，并将减少死亡、心肌梗死、主要围手术期并发症和因不稳定型心绞痛住院的复合主要终点。这项150家临床试验机构的实用性试验将在24个月内随机抽取10，000名临床确定的CAD低中度风险症状患者。所有后续诊断和治疗管理将基于最新的临床实践指南建议，并由治疗护理团队自行决定。患者将接受长达48个月的随访（中位2.5年）。该试验设计经过精心设计，以确保结果的最广泛适用性，包括全方位的实践环境、护理人员专业和与全国绝大多数胸痛患者护理所需的临床决策直接相关的测试类型。预计功能测试或常规治疗组的事件发生率为9%，每个测试组入组5，000例患者将提供90%的把握度，以检测复合主要终点相对降低20%。次要终点包括主要终点的组成部分以及1）医疗成本、资源利用、成本效益; 2）健康相关生活质量。 该提案包括牵头临床协调中心（CCC; Pamela S道格拉斯，PI）、统计和数据协调中心（SDCC; Kerry L Lee，PI）、经济学和生活质量（EQOL;丹尼尔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，成像和检测专业知识，现场管理，患者随访，统计分析和数据管理。 尽管医疗成本非常重要，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作为首个针对疑似CAD患者的两种诊断检测策略的大型随机比较，将提供有关临床结局和替代方法成本的关键证据，这些替代方法是未来几年塑造胸痛患者临床实践建议和医疗保健政策所必需的。

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.