Occluded Artery Trial: Long Term Follow-Up

动脉闭塞试验：长期随访

• 批准号: 7301705
• 负责人: Judith S Hochman
• 金额: $ 84.22万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2011-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7301705
• 关键词: Age; Ancillary Study; Appendix; Arteries; Award; Benefits and Risks; Cardiology; Cardiovascular Diseases; Caring; Categories; Cessation of life; Characteristics; Class; Clinical; Clinical Research; Clinical Trials; Collaborations; Communities; Companions; Complex; Congestive; Congestive Heart Failure; Coronary; Coronary Occlusions; Coronary artery; Country; Data; Data Analyses; Data Coordinating Center; Databases; Depth; Development; EFRAC; Economics; Electrocardiogram; End Point; Enrollment; Event; Functional disorder; Funding; Grant; Guidelines; Health; Heart failure; Hospitalization; Howard Temin Award; Infarction; International; Intervention; Invasive; Investigation; Investments; Laboratories; Leadership; Left Ventricular Function; Left Ventricular Remodeling; Location; Maryland; Medical; Medical center; Myocardial Infarction; New York; Operative Surgical Procedures; Outcome; Patients; Phase; Population; Procedures; Quality of life; Race; Randomized; Randomized Controlled Clinical Trials; Rate; Recurrence; Research Institute; Research Personnel; Resources; Risk; Risk Factors; SF-36; Site; Specific qualifier value; Subgroup; Symptoms; Testing; Time; United States National Institutes of Health; Universities; Upper arm; Weight; Well in self; Work; acute coronary syndrome; adjudicate; artery occlusion; base; clinical research site; cohort; cost; day; design; exhaust; follow-up; functional status; insight; medical schools; outcome forecast; programs; repaired; sex; size; trend

DESCRIPTION (provided by applicant): The Occluded Artery Trial (OAT) is an NHLBI-funded international, multicenter, randomized trial testing the hypothesis that percutaneous coronary intervention with optimal medical therapy is superior in reducing clinical events compared to optimal medical therapy alone in stable, but high-risk, post-myocardial infarction patients. OAT patients have totally occluded infarct-related arteries 3-28 days after myocardial infarction (Ml) and at least one additional high risk feature, either reduced left ventricular function (ejection fraction < 50%) or proximal coronary artery occlusion. Patients were randomized between 2000 and 2005 to either medical management or medical management plus percutaneous coronary intervention and stenting. The primary endpoint was a composite of death, class IV congestive heart failure (CHF) and recurrent Ml. After an average of three years of follow up of 2,166 enrolled patients, there was no significant difference between the treatment groups for the primary endpoint. This application for a competitive renewal proposes: A) to extend follow up by an additional 3 years to achieve an average follow up of approximately 6 years on the OAT cohort to examine late trends in events and quality of life and B) to perform additional in depth analyses on the original OAT cohort followed by 3 years. Extended follow up will also increase power to examine prespecified subgroups. Extension of follow up in OAT is designed to provide the medical community with definitive data on the risks and benefits of a strategy of routine PCI of persistently occluded infarct-related arteries in stable patients last post-Mi. OAT has over 200 participating clinical sites, a Clinical Coordinating Center (CCC) at New York University Medical School, a Co-CCC at Mount Sinai Medical Center (Miami), a Data Coordinating Center (DCC) at Maryland Medical Research Institute and an Economics and Quality of Life Coordinating Center at Duke Clinical Research Institute.

描述（由申请人提供）： 封闭的动脉试验（OAT）是NHLBI资助的国际多中心，随机试验，该试验检验了以下假设：与单独的稳定，高风险的，高风险的后，伴有高风险的，高风险的，高风险的，高风险的医疗疗法相比，在临床事件中，经皮冠状动脉介入疗法在降低临床事件中是优越的。燕麦患者在心肌梗塞（ML）后3-28天完全阻塞了与梗死相关的动脉，并且至少有一个额外的高风险特征，左心室功能降低（射血分数<50％）或近端冠状动脉闭塞。在2000年至2005年之间，患者被随机分配给医疗管理或医疗管理以及经皮冠状动脉干预和支架。主要终点是死亡，IV类充血性心力衰竭（CHF）和经常性ML的复合物。在平均三年的随访中，有2,166名参赛者的患者后，主要终点的治疗组之间没有显着差异。该竞争性更新的申请提出：a）将额外的后续行列延长3年，以在燕麦队列上进行大约6年的平均随访，以检查事件和生活质量的后期趋势，b）在原始燕麦队列中进行额外的深度分析，然后再进行3年。扩展的随访还将增加检查预定亚组的功率。燕麦中后续行动的扩展旨在为医学界提供有关稳定患者稳定患者的常规PCI的风险和好处的确切数据。 OAT拥有200多个参与的临床站点，这是纽约大学医学院的临床协调中心（CCC），位于西奈山医学中心（迈阿密）的共同CCC，马里兰州医学研究所的数据协调中心（DCC），以及杜克临床研究所的经济和生活质量协调中心的经济和生活质量。