PROMISE Trial: EQOL Coordinating Center
PROMISE 试用:EQOL 协调中心
基本信息
- 批准号:7940907
- 负责人:
- 金额:$ 35.1万
- 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 2012-03-31
- 项目状态:已结题
- 来源:
- 关键词:AddressAmericanAnatomyAngiographyArtsCardiacCaregiversCaringCessation of lifeChest PainClinicalClinical Practice GuidelineClinical Trials DesignCompanionsCoronaryCoronary ArteriosclerosisCoronary arteryCoronary heart diseaseData Coordinating CenterDiagnosticDiagnostic testsEchocardiographyEconomicsElectrocardiogramEnrollmentEnsureEvaluation StudiesEventExerciseFacultyGoalsHealthHealth Care CostsHealth PolicyHeart DiseasesHospitalizationImageLeadLeadershipLifeMedicalMyocardial InfarctionNuclearOutcomePatientsPhysiciansQuality of lifeQuality-Adjusted Life YearsRandomizedRecommendationRelative (related person)ResourcesRiskRoleServicesShapesSiteSliceStressStress TestsTestingTherapeuticUnstable anginaarmbaseclinical practicecostcost effectivenessdata managementexperiencefollow-uphealth related quality of lifeimprovedmedical specialtiesnew technologypragmatic trialprimary outcomeprospectivepublic health relevancerandomized trialresponsestandard caretreatment as usualtreatment strategytrial 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 }}
Daniel B Mark其他文献
Prognostic Impact of Repeated NT-proBNP Measurements in Patients With Heart Failure With Reduced Ejection Fraction.
重复 NT-proBNP 测量对射血分数降低的心力衰竭患者的预后影响。
- DOI:
10.1016/j.jchf.2023.11.007 - 发表时间:
2023 - 期刊:
- 影响因子:0
- 作者:
Michael A Fuery;E. Leifer;Marc D. Samsky;Sounok Sen;C. M. O’Connor;M. Fiuzat;J. Ezekowitz;Ileana L. Piña;D. Whellan;Daniel B Mark;G. Felker;N. Desai;J. Januzzi;Tariq Ahmad - 通讯作者:
Tariq Ahmad
1153-74 Physician counseling can influence health-related quality of life
- DOI:
10.1016/s0735-1097(04)91763-9 - 发表时间:
2004-03-03 - 期刊:
- 影响因子:
- 作者:
Barbara L Lytle;Gregory J Shook;Karen P Alexander;Patricia A Cowper;Daniel B Mark;Elizabeth R DeLong - 通讯作者:
Elizabeth R DeLong
Combinations of First Responder and Drone Delivery to Achieve 5-Minute AED Deployment in OHCA
急救人员和无人机交付相结合,在 OHCA 中实现 5 分钟 AED 部署
- DOI:
- 发表时间:
2024 - 期刊:
- 影响因子:0
- 作者:
M. A. Starks;Jamal Chu;K.H. Benjamin Leung;Audrey L. Blewer;Denise Simmons;Carolina Malta Hansen;A. Joiner;José G. Cabañas;Matthew R. Harmody;R. D. Nelson;Bryan F. McNally;Joseph P Ornato;Christopher B. Granger;Timothy C.Y. Chan;Daniel B Mark - 通讯作者:
Daniel B Mark
Navigating the scylla and charybdis of chest pain management in the emergency department. Is a computer the answer?
浏览急诊科胸痛管理的Scylla和Charybdis。
- DOI:
- 发表时间:
2002 - 期刊:
- 影响因子:5.9
- 作者:
L. Newby;Daniel B Mark - 通讯作者:
Daniel B Mark
Daniel B Mark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('Daniel B Mark', 18)}}的其他基金
Guiding Evidence Based Therapy Using Biomarker Intensified Treatment (EQOL)
使用生物标志物强化治疗 (EQOL) 指导循证治疗
- 批准号:
8235545 - 财政年份:2012
- 资助金额:
$ 35.1万 - 项目类别:
Guiding Evidence Based Therapy Using Biomarker Intensified Treatment (EQOL)
使用生物标志物强化治疗 (EQOL) 指导循证治疗
- 批准号:
8894069 - 财政年份:2012
- 资助金额:
$ 35.1万 - 项目类别:
Guiding Evidence Based Therapy Using Biomarker Intensified Treatment (EQOL)
使用生物标志物强化治疗 (EQOL) 指导循证治疗
- 批准号:
8479428 - 财政年份:2012
- 资助金额:
$ 35.1万 - 项目类别:
Guiding Evidence Based Therapy Using Biomarker Intensified Treatment (EQOL)
使用生物标志物强化治疗 (EQOL) 指导循证治疗
- 批准号:
8657098 - 财政年份:2012
- 资助金额:
$ 35.1万 - 项目类别:
相似海外基金
Collaborative Research: REU Site: Earth and Planetary Science and Astrophysics REU at the American Museum of Natural History in Collaboration with the City University of New York
合作研究:REU 地点:地球与行星科学和天体物理学 REU 与纽约市立大学合作,位于美国自然历史博物馆
- 批准号:
2348998 - 财政年份:2025
- 资助金额:
$ 35.1万 - 项目类别:
Standard Grant
Collaborative Research: REU Site: Earth and Planetary Science and Astrophysics REU at the American Museum of Natural History in Collaboration with the City University of New York
合作研究:REU 地点:地球与行星科学和天体物理学 REU 与纽约市立大学合作,位于美国自然历史博物馆
- 批准号:
2348999 - 财政年份:2025
- 资助金额:
$ 35.1万 - 项目类别:
Standard Grant
Understanding Latin American Challenges in the 21st Century (LAC-EU)
了解拉丁美洲在 21 世纪面临的挑战 (LAC-EU)
- 批准号:
EP/Y034694/1 - 财政年份:2024
- 资助金额:
$ 35.1万 - 项目类别:
Research Grant
Conference: North American High Order Methods Con (NAHOMCon)
会议:北美高阶方法大会 (NAHOMCon)
- 批准号:
2333724 - 财政年份:2024
- 资助金额:
$ 35.1万 - 项目类别:
Standard Grant
Collaborative Research: RUI: Continental-Scale Study of Jura-Cretaceous Basins and Melanges along the Backbone of the North American Cordillera-A Test of Mesozoic Subduction Models
合作研究:RUI:北美科迪勒拉山脊沿线汝拉-白垩纪盆地和混杂岩的大陆尺度研究——中生代俯冲模型的检验
- 批准号:
2346565 - 财政年份:2024
- 资助金额:
$ 35.1万 - 项目类别:
Standard Grant
REU Site: Research Experiences for American Leadership of Industry with Zero Emissions by 2050 (REALIZE-2050)
REU 网站:2050 年美国零排放工业领先地位的研究经验 (REALIZE-2050)
- 批准号:
2349580 - 财政年份:2024
- 资助金额:
$ 35.1万 - 项目类别:
Standard Grant
Collaborative Research: RUI: Continental-Scale Study of Jura-Cretaceous Basins and Melanges along the Backbone of the North American Cordillera-A Test of Mesozoic Subduction Models
合作研究:RUI:北美科迪勒拉山脊沿线汝拉-白垩纪盆地和混杂岩的大陆尺度研究——中生代俯冲模型的检验
- 批准号:
2346564 - 财政年份:2024
- 资助金额:
$ 35.1万 - 项目类别:
Standard Grant
Conference: Latin American School of Algebraic Geometry
会议:拉丁美洲代数几何学院
- 批准号:
2401164 - 财政年份:2024
- 资助金额:
$ 35.1万 - 项目类别:
Standard Grant
Collaborative Research: Ionospheric Density Response to American Solar Eclipses Using Coordinated Radio Observations with Modeling Support
合作研究:利用协调射电观测和建模支持对美国日食的电离层密度响应
- 批准号:
2412294 - 财政年份:2024
- 资助金额:
$ 35.1万 - 项目类别:
Standard Grant
Conference: Doctoral Consortium at Student Research Workshop at the Annual Conference of the North American Chapter of the Association for Computational Linguistics (NAACL)
会议:计算语言学协会 (NAACL) 北美分会年会学生研究研讨会上的博士联盟
- 批准号:
2415059 - 财政年份:2024
- 资助金额:
$ 35.1万 - 项目类别:
Standard Grant