The ISCHEMIA Trial - EQOL

缺血试验 - EQOL

基本信息

  • 批准号:
    8424993
  • 负责人:
  • 金额:
    $ 34.38万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2011
  • 资助国家:
    美国
  • 起止时间:
    2011-07-22 至 2017-10-14
  • 项目状态:
    已结题

项目摘要

DESCRIPTION (provided by applicant): The long-term objective of the proposed trial, entitled International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA), is to define the role of an invasive approach in patients with stable ischemic heart disease (SIHD). The trial hypothesis is that cardiac catheterization followed by complete revascularization plus optimal medical therapy (OMT) is superior to OMT alone as the strategy for initial management of patients with moderate-to-severe ischemia on stress imaging. The primary endpoint will be time to cardiovascular death, myocardial infarction (MI), or hospitalization for an acute cardiac event (unstable angina, resuscitated cardiac arrest, or heart failure). We will also test the hypothesis that the invasive strategy will improve quality of life. Cost effectiveness will be assessed. The COURAGE and BARI-2D trials found that an initial management strategy of coronary revascularization did not reduce the risk of death or MI in SIHD compared with OMT alone when patients were selected based on coronary anatomy. These data have prompted inference that cardiac catheterization (cath) may not be required in stable patients. Cath in such patients usually leads to revascularization. COURAGE and BARI-2D included a broad range of severity of myocardial ischemia on provocative testing; most patients had mild-moderate ischemia. However, observational data suggest that revascularization is associated with a lower likelihood of death and MI in patients with moderate-severe ischemia but not in patients with lesser degrees of ischemia. Only about half of patients with moderate-severe ischemia are referred for cath. It is unknown whether use rates for cath and revascularization are appropriate for optimal patient management in the era of modern medical therapy (high dose statins and antiplatelet therapy). This issue cannot be resolved using available data, because prior clinical trials in SIHD have enrolled patients after cath, at which point there is substantial selection bias for enrollment based on anatomy. Given the potential for extension of life and avoidance of adverse clinical cardiac events as a result of revascularization, and the significant expense and risks associated with invasive management, the role of an invasive strategy is critically important to define. The proposed ISCHEMIA trial will be a prospective, multicenter, international, randomized, controlled trial that will directly address the need for an invasive strategy, cath and revascularization, in patients with SIHD. We plan to enroll approximately 8,000 patients from among 400-500 sites with moderate-severe ischemia and left ventricular ejection fraction >35% who are recruited after stress imaging. Patients who meet eligibility criteria will undergo blinded coronary CT angiography to exclude significant left main coronary artery disease and nonobstructive disease. Patients randomized to the invasive group will undergo optimal revascularization following study guidelines.
描述(由申请人提供): 这项名为“国际医疗和侵入性方法(ISCHEMIA)健康效果比较研究”的拟议试验的长期目标是确定侵入性方法在稳定性缺血性心脏病(SIHD)患者中的作用。试验假设是,心脏导管插入术后完全血运重建加最佳药物治疗(OMT)上级OMT单独作为负荷成像显示中重度缺血患者的初始管理策略。主要终点为至心血管死亡、心肌梗死(MI)或因急性心脏事件(不稳定型心绞痛、心脏骤停复苏或心力衰竭)住院的时间。我们还将检验侵入性策略将改善生活质量的假设。将评估成本效益。 COUHD和巴里-2D试验发现,当根据冠状动脉解剖结构选择患者时,与单独OMT相比,SIHD中冠状动脉血运重建的初始管理策略并未降低死亡或MI的风险。这些数据提示推断,稳定的患者可能不需要心导管插入术(cath)。导管在这类患者中通常导致血运重建。COURAGE和巴里-2D包括激发试验中广泛的心肌缺血严重程度;大多数患者有轻度-中度缺血。然而,观察数据表明,血运重建与中重度缺血患者的死亡和MI可能性较低相关,但与缺血程度较轻的患者无关。只有大约一半的中重度缺血患者被转诊接受导管插入术。在现代医学治疗(高剂量他汀类药物和抗血小板治疗)时代,导管插入术和血运重建术的使用率是否适用于最佳患者管理尚不清楚。使用现有数据无法解决该问题,因为SIHD的既往临床试验已入组导管插入后患者,此时基于解剖结构的入组存在大量选择偏倚。考虑到血运重建可能延长生命和避免不良临床心脏事件,以及与侵入性管理相关的重大费用和风险,定义侵入性策略的作用至关重要。 拟定的ISCHEMIA试验将是一项前瞻性、多中心、国际、随机、对照试验,将直接解决SIHD患者对侵入性策略、导管插入和血运重建的需求。我们计划从400-500个中心招募约8,000名中重度缺血且左心室射血分数>35%的患者,这些患者在负荷成像后招募。符合合格标准的患者将接受设盲冠状动脉CT血管造影,以排除严重的左主干冠状动脉疾病和非阻塞性疾病。随机分配至侵入性组的患者将按照研究指南进行最佳血运重建。

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。

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:
    $ 34.38万
  • 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:
    $ 34.38万
  • 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:
    $ 34.38万
  • 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:
    $ 34.38万
  • 项目类别:
The ISCHEMIA Trial - EQOL
缺血试验 - EQOL
  • 批准号:
    8306080
  • 财政年份:
    2011
  • 资助金额:
    $ 34.38万
  • 项目类别:
The ISCHEMIA Trial - EQOL
缺血试验 - EQOL
  • 批准号:
    8027079
  • 财政年份:
    2011
  • 资助金额:
    $ 34.38万
  • 项目类别:
The ISCHEMIA Trial - EQOL
缺血试验 - EQOL
  • 批准号:
    8636040
  • 财政年份:
    2011
  • 资助金额:
    $ 34.38万
  • 项目类别:
The ISCHEMIA Trial - EQOL
缺血试验 - EQOL
  • 批准号:
    9253430
  • 财政年份:
    2011
  • 资助金额:
    $ 34.38万
  • 项目类别:
CABANA EQOL Trial
CABANA EQOL 试用
  • 批准号:
    7762707
  • 财政年份:
    2009
  • 资助金额:
    $ 34.38万
  • 项目类别:
PROMISE Trial: EQOL Coordinating Center
PROMISE 试用:EQOL 协调中心
  • 批准号:
    7940907
  • 财政年份:
    2009
  • 资助金额:
    $ 34.38万
  • 项目类别:

相似海外基金

Rational design of rapidly translatable, highly antigenic and novel recombinant immunogens to address deficiencies of current snakebite treatments
合理设计可快速翻译、高抗原性和新型重组免疫原,以解决当前蛇咬伤治疗的缺陷
  • 批准号:
    MR/S03398X/2
  • 财政年份:
    2024
  • 资助金额:
    $ 34.38万
  • 项目类别:
    Fellowship
Re-thinking drug nanocrystals as highly loaded vectors to address key unmet therapeutic challenges
重新思考药物纳米晶体作为高负载载体以解决关键的未满足的治疗挑战
  • 批准号:
    EP/Y001486/1
  • 财政年份:
    2024
  • 资助金额:
    $ 34.38万
  • 项目类别:
    Research Grant
CAREER: FEAST (Food Ecosystems And circularity for Sustainable Transformation) framework to address Hidden Hunger
职业:FEAST(食品生态系统和可持续转型循环)框架解决隐性饥饿
  • 批准号:
    2338423
  • 财政年份:
    2024
  • 资助金额:
    $ 34.38万
  • 项目类别:
    Continuing Grant
Metrology to address ion suppression in multimodal mass spectrometry imaging with application in oncology
计量学解决多模态质谱成像中的离子抑制问题及其在肿瘤学中的应用
  • 批准号:
    MR/X03657X/1
  • 财政年份:
    2024
  • 资助金额:
    $ 34.38万
  • 项目类别:
    Fellowship
CRII: SHF: A Novel Address Translation Architecture for Virtualized Clouds
CRII:SHF:一种用于虚拟化云的新型地址转换架构
  • 批准号:
    2348066
  • 财政年份:
    2024
  • 资助金额:
    $ 34.38万
  • 项目类别:
    Standard Grant
The Abundance Project: Enhancing Cultural & Green Inclusion in Social Prescribing in Southwest London to Address Ethnic Inequalities in Mental Health
丰富项目:增强文化
  • 批准号:
    AH/Z505481/1
  • 财政年份:
    2024
  • 资助金额:
    $ 34.38万
  • 项目类别:
    Research Grant
ERAMET - Ecosystem for rapid adoption of modelling and simulation METhods to address regulatory needs in the development of orphan and paediatric medicines
ERAMET - 快速采用建模和模拟方法的生态系统,以满足孤儿药和儿科药物开发中的监管需求
  • 批准号:
    10107647
  • 财政年份:
    2024
  • 资助金额:
    $ 34.38万
  • 项目类别:
    EU-Funded
BIORETS: Convergence Research Experiences for Teachers in Synthetic and Systems Biology to Address Challenges in Food, Health, Energy, and Environment
BIORETS:合成和系统生物学教师的融合研究经验,以应对食品、健康、能源和环境方面的挑战
  • 批准号:
    2341402
  • 财政年份:
    2024
  • 资助金额:
    $ 34.38万
  • 项目类别:
    Standard Grant
Ecosystem for rapid adoption of modelling and simulation METhods to address regulatory needs in the development of orphan and paediatric medicines
快速采用建模和模拟方法的生态系统,以满足孤儿药和儿科药物开发中的监管需求
  • 批准号:
    10106221
  • 财政年份:
    2024
  • 资助金额:
    $ 34.38万
  • 项目类别:
    EU-Funded
Recite: Building Research by Communities to Address Inequities through Expression
背诵:社区开展研究,通过表达解决不平等问题
  • 批准号:
    AH/Z505341/1
  • 财政年份:
    2024
  • 资助金额:
    $ 34.38万
  • 项目类别:
    Research Grant
{{ showInfoDetail.title }}

作者:{{ showInfoDetail.author }}

知道了