PROMISE Trial: Clinical Coordinating Center
PROMISE 试验:临床协调中心
基本信息
- 批准号:7768791
- 负责人:
- 金额:$ 556.65万
- 依托单位:
- 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 2011-07-31
- 项目状态:已结题
- 来源:
- 关键词:Accident and Emergency departmentAccountingAddressAdoptionAmericanAnatomyAngiographyArtsCardiacCaregiversCaringCause of DeathCessation of lifeChest PainClinicalClinical Practice GuidelineClinical ResearchClinical TrialsClinical Trials DesignConflict (Psychology)CoronaryCoronary ArteriosclerosisCoronary arteryCoronary heart diseaseData Coordinating CenterDiagnosticDiagnostic testsEchocardiographyEconomicsElectrocardiogramEnrollmentEnsureEquipoiseEvaluation StudiesEventEvidence Based MedicineExerciseFacultyHealthHealth Care CostsHealth PolicyHeart DiseasesHemorrhageHome environmentHospitalizationImageKidney FailureLaboratoriesLeadLeadershipMedicalMyocardial InfarctionMyocardial IschemiaNational Heart, Lung, and Blood InstituteNuclearOutcomePatientsPhysiciansPhysicians&apos OfficesPractice GuidelinesQuality of lifeRandomizedRandomized Controlled Clinical TrialsRecommendationRelative (related person)ResearchResearch InstituteResearch PersonnelResourcesRiskRoleServicesShapesSiteSliceStressStress TestsStrokeTest ResultTestingTherapeuticUncertaintyUnstable anginaUpper armVisitbaseclinical practicecostcost effectivenessdata managementeconomic outcomeexperiencefollow-uphealth related quality of lifeimprovedmedical specialtiesnew technologypragmatic trialprospectivepublic health relevanceresponsestatistical centerstatisticstreatment as usualtrial comparing
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,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。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Pamela Susan Douglas其他文献
Pamela Susan Douglas的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('Pamela Susan Douglas', 18)}}的其他基金
1/2 REPRIEVE Extension for Trial Completion
1/2 REPRIEVE 延期以完成试验
- 批准号:
10479464 - 财政年份:2023
- 资助金额:
$ 556.65万 - 项目类别:
Clinical and Molecular Epidemiology of High Risk Coronary Plaque
高危冠状动脉斑块的临床和分子流行病学
- 批准号:
10219348 - 财政年份:2019
- 资助金额:
$ 556.65万 - 项目类别:
Clinical and Molecular Epidemiology of High Risk Coronary Plaque
高危冠状动脉斑块的临床和分子流行病学
- 批准号:
10459303 - 财政年份:2019
- 资助金额:
$ 556.65万 - 项目类别:
Clinical and Molecular Epidemiology of High Risk Coronary Plaque
高危冠状动脉斑块的临床和分子流行病学
- 批准号:
9817023 - 财政年份:2019
- 资助金额:
$ 556.65万 - 项目类别:
Data Concepts and Terminology Standards in Cardiovascular Imaging
心血管成像中的数据概念和术语标准
- 批准号:
8514314 - 财政年份:2012
- 资助金额:
$ 556.65万 - 项目类别:
PROMISE Trial: Clinical Coordinating Center
PROMISE 试验:临床协调中心
- 批准号:
8153243 - 财政年份:2009
- 资助金额:
$ 556.65万 - 项目类别:
PROMISE Trial: Clinical Coordinating Center
PROMISE 试验:临床协调中心
- 批准号:
8529018 - 财政年份:2009
- 资助金额:
$ 556.65万 - 项目类别:
相似海外基金
Unraveling the Dynamics of International Accounting: Exploring the Impact of IFRS Adoption on Firms' Financial Reporting and Business Strategies
揭示国际会计的动态:探索采用 IFRS 对公司财务报告和业务战略的影响
- 批准号:
24K16488 - 财政年份:2024
- 资助金额:
$ 556.65万 - 项目类别:
Grant-in-Aid for Early-Career Scientists
Mighty Accounting - Accountancy Automation for 1-person limited companies.
Mighty Accounting - 1 人有限公司的会计自动化。
- 批准号:
10100360 - 财政年份:2024
- 资助金额:
$ 556.65万 - 项目类别:
Collaborative R&D
Accounting for the Fall of Silver? Western exchange banking practice, 1870-1910
白银下跌的原因是什么?
- 批准号:
24K04974 - 财政年份:2024
- 资助金额:
$ 556.65万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
A New Direction in Accounting Education for IT Human Resources
IT人力资源会计教育的新方向
- 批准号:
23K01686 - 财政年份:2023
- 资助金额:
$ 556.65万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
An empirical and theoretical study of the double-accounting system in 19th-century American and British public utility companies
19世纪美国和英国公用事业公司双重会计制度的实证和理论研究
- 批准号:
23K01692 - 财政年份:2023
- 资助金额:
$ 556.65万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
An Empirical Analysis of the Value Effect: An Accounting Viewpoint
价值效应的实证分析:会计观点
- 批准号:
23K01695 - 财政年份:2023
- 资助金额:
$ 556.65万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Accounting model for improving performance on the health and productivity management
提高健康和生产力管理绩效的会计模型
- 批准号:
23K01713 - 财政年份:2023
- 资助金额:
$ 556.65万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
CPS: Medium: Making Every Drop Count: Accounting for Spatiotemporal Variability of Water Needs for Proactive Scheduling of Variable Rate Irrigation Systems
CPS:中:让每一滴水都发挥作用:考虑用水需求的时空变化,主动调度可变速率灌溉系统
- 批准号:
2312319 - 财政年份:2023
- 资助金额:
$ 556.65万 - 项目类别:
Standard Grant
New Role of Not-for-Profit Entities and Their Accounting Standards to Be Unified
非营利实体的新角色及其会计准则将统一
- 批准号:
23K01715 - 财政年份:2023
- 资助金额:
$ 556.65万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Improving Age- and Cause-Specific Under-Five Mortality Rates (ACSU5MR) by Systematically Accounting Measurement Errors to Inform Child Survival Decision Making in Low Income Countries
通过系统地核算测量误差来改善特定年龄和特定原因的五岁以下死亡率 (ACSU5MR),为低收入国家的儿童生存决策提供信息
- 批准号:
10585388 - 财政年份:2023
- 资助金额:
$ 556.65万 - 项目类别: