Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts: Quality of Life (ROMA:QOL)

单动脉移植与多动脉移植临床结果的随机比较：生活质量 (ROMA:QOL)

基本信息

批准号：
10594585
负责人：
Mario FL Gaudino
金额：
$ 83.62万
依托单位：
WEILL MEDICAL COLL OF CORNELL UNIV
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-04-21 至 2025-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10594585
关键词：
Address Affect American Ancillary Study Anxiety Benefits and Risks Cardiac Caring Cessation of life Climacteric Clinical Clinical Practice Guideline Clinical Trials Communication Coronary Artery Bypass Coronary Vessels Coronary heart disease Country Decision Making Diabetes Mellitus Diagnosis Dimensions Disease Distress Enrollment Event Fatigue Foundations Funding Future Goals Health Health Priorities Health Surveys Infection Information Systems Infrastructure Legal patent Life Expectancy Measures Mental Depression Mental Health Morbidity - disease rate Multicenter Trials Myocardial Infarction National Heart, Lung, and Blood Institute Observational Study Operative Surgical Procedures Outcome Outcome Measure Outcome Study Pain interference Parents Participant Patient Outcomes Assessments Patient risk Patient-Focused Outcomes Patients Physical Function Population Procedures Quality of life Questionnaires Randomized Recommendation Reporting Representational Oligonucleotide Microarray Analysis Research Research Personnel Research Proposals Risk Risk Factors Saphenous Vein Site Sleep disturbances Specific qualifier value Stroke Subgroup Surgical complication Surveys Symptoms Techniques Testing Time United States National Institutes of Health Vein graft Venous Woman cohort diabetic patient experience follow-up global health health assessment health difference health related quality of life heart disease risk high risk improved instrument men mortality novel painful neuropathy physical conditioning postoperative recovery prevent primary outcome prospective recruit sex shared decision making standard of care surgical risk tool treatment response trial comparing wound healing

项目摘要

PROJECT SUMMARY/ABSTRACT Coronary heart disease (CHD) affects over 18.2 million Americans and it is rising globally. Coronary artery bypass graft (CABG) surgery is the standard of care for multi-vessel CHD and has dramatically improved life expectancy. However, it is not known how CABG surgery impacts symptom burden or health related quality of life (HRQOL), two outcomes that matter to patients. Furthermore, CABG surgery can use single arterial grafts (SAG) or multiple arterial grafts (MAG). Observational research suggests that MAG prolongs survival compared to SAG and decreases risk of surgical complications, heart attack, stroke, infection, and death; however, differences in HRQOL between these two surgical standards of care are not known. The investigators aim to define the impact of CABG surgery on HRQOL and symptom burden among 2,111 men and women with multi- vessel CHD in the context of the large multinational ROMA trial that is testing the hypothesis that clinical outcomes with MAG are superior to SAG over 5 years. The ROMA:QOL ancillary study leverages the infrastructure of the parent trial to add HRQOL and symptom outcomes. The overall goal of this R01 is to compare HRQOL and symptoms following SAG vs. MAG CABG surgery. In Aim 1, the investigators will quantify changes in the well-validated Seattle Angina Questionnaire as a measure of disease-specific HRQOL and the widely used Short Form 12-item survey as a generic measure of HRQOL. In Aim 2, the investigators will quantify changes in physical and mental health symptoms and physical functioning using the NIH Patient Reported Outcomes Measure Information System (PROMIS). A secondary goal is to quantify minimally important clinical differences for the PROMIS measures post CABG surgery. Pre-specified subgroup analyses will evaluate HRQOL and symptom burden in women compared with men, and patients with and without diabetes. Compared to men, women are more likely to be underdiagnosed with CHD and are less likely to be referred for CABG surgery. Diabetes is an established CHD risk factor, especially multi-vessel CHD, and diabetic patients are at higher risk for surgical complications, poor wound healing, and worse clinical outcomes after CABG surgery. The hypothesis is that both groups will experience improvements in HRQOL and symptoms at 12 months, but MAG will be superior to SAG. The results will generate missing evidence about the impact of MAG vs. SAG surgery on dimensions of health prioritized by patients. This missing evidence prevents fully informed decision-making about the risks and benefits of CABG surgery in general, and MAG vs. SAG specifically. This study will influence future treatment recommendations and clinical practice guidelines and lay the foundation for shared decision- making tools to communicate risks and benefits to patients. The proposed study addresses NIH’s call to investigate factors that account for differences in health and treatment response to novel surgical strategies, overall and by sex.

项目概要/摘要冠心病 (CHD) 影响着超过 1820 万美国人，并且冠状动脉疾病的发病率在全球范围内呈上升趋势。旁路移植术 (CABG) 手术是多支血管冠心病的标准治疗方法，可显着改善患者的生活然而，目前尚不清楚 CABG 手术如何影响症状负担或健康相关质量。生活（HRQOL），这两个结果对患者很重要此外，CABG 手术可以使用单动脉移植物。 (SAG) 或多动脉移植物 (MAG) 观察性研究表明，相比之下，MAG 可延长生存期。然而，SAG 并降低手术并发症、心脏病、中风、感染和死亡的风险；这两种手术护理标准之间的 HRQOL 差异尚不清楚。定义 CABG 手术对 2,111 名患有多发性硬化症的男性和女性的 HRQOL 和症状负担的影响大型跨国 ROMA 试验背景下的血管性 CHD，该试验正在检验以下假设：临床 5 年来，MAG 的结果优于 SAG。ROMA:QOL 辅助研究利用了 R01 的总体目标是添加 HRQOL 和症状结果。比较 SAG 与 MAG CABG 手术后的 HRQOL 和症状在目标 1 中，研究人员将量化。作为衡量疾病特异性 HRQOL 的指标，经过充分验证的西雅图心绞痛问卷的变化广泛使用的简式 12 项调查作为 HRQOL 的通用衡量标准在目标 2 中，调查人员将进行量化。使用 NIH 患者报告的身体和心理健康症状以及身体机能的变化结果测量信息系统（PROMIS）的第二个目标是量化最不重要的临床。将评估 CABG 手术后 PROMIS 测量的差异。女性与男性、患有或不患有糖尿病的患者的 HRQOL 和症状负担。与男性相比，女性更容易被冠心病诊断不足，并且不太可能被转诊进行冠状动脉搭桥术糖尿病是一种既定的冠心病危险因素，尤其是多支冠心病，糖尿病患者处于危险之中。 CABG 手术后，手术并发症、伤口愈合不良和临床结果较差的风险更高。假设两组在 12 个月时 HRQOL 和症状都会得到改善，但 MAG 结果将产生关于 MAG 与 SAG 手术影响的缺失证据。缺乏证据阻碍了患者做出充分知情的决策。关于 CABG 手术的一般风险和益处，以及 MAG 与 SAG 的具体比较，这项研究将产生影响。未来的治疗建议和临床实践指南，并为共同决策奠定基础拟议的研究响应了 NIH 的号召，制作向患者传达风险和益处的工具。研究导致健康和对新手术策略的治疗反应差异的因素，总体而言和按性别划分。