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)

• 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
• 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

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.

项目摘要/摘要 冠心病(CHD)影响着超过1820万美国人，并且在全球范围内呈上升趋势。冠状动脉 搭桥手术(CABG)是治疗多支冠状动脉病变的标准手术，显著改善了患者的生活。 期望值。然而，CABG手术对症状负担或健康相关质量的影响尚不清楚。 生命(HRQOL)，两个对患者至关重要的结果。此外，CABG手术可以使用单一动脉移植物 (SAG)或多动脉桥(MAG)。观察性研究表明MAG可延长存活期 降低手术并发症、心脏病发作、中风、感染和死亡的风险；然而， 这两种外科护理标准之间的HRQOL差异尚不清楚。调查人员的目标是 明确冠状动脉旁路手术对2,111名患有多发性心脏病的男性和女性的HRQOL和症状负担的影响 血管先心病在大型跨国罗姆试验的背景下，该试验正在测试临床上 5年以上MAG组疗效优于SAG组。罗姆：生活质量辅助研究利用 父母试验的基础设施，以增加HRQOL和症状结果。这款R01的总体目标是 比较SAG与MAG冠状动脉搭桥术后的HRQOL和症状。在目标1中，调查人员将量化 验证良好的西雅图心绞痛问卷的变化作为疾病特有的HRQOL和 被广泛使用的简式12项调查作为HRQOL的一般测量。在目标2中，调查人员将量化 NIH患者的身心健康症状和身体功能的变化 成果计量信息系统(PROIS)。第二个目标是量化最不重要的临床 冠状动脉旁路移植术后PROMIS测量的差异。预先指定的子组分析将评估 女性与男性、糖尿病患者和非糖尿病患者的HRQOL和症状负担比较。相比较 对于男性来说，女性更有可能被低估为冠心病，而不太可能被转诊为冠状动脉搭桥术 做手术。糖尿病是冠心病的危险因素，尤其是多支血管病变，糖尿病患者处于 CABG术后手术并发症风险高、伤口愈合差、临床结果差。这个 假设两组在12个月后都会在HRQOL和症状方面有所改善，但MAG 将优于SAG。结果将产生关于MAG和SAG手术影响的缺失证据 在患者优先考虑的健康维度上。这种缺失的证据妨碍了充分知情的决策。 关于CABG手术的总体风险和好处，以及MAG和SAG的具体情况。这项研究将对 未来的治疗建议和临床实践指南，并为共享决策奠定基础- 制作工具，向患者传达风险和好处。这项拟议的研究回应了美国国立卫生研究院对 调查对新的手术策略的健康和治疗反应不同的因素， 总体上和性别上。