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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：
10378019
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/10378019
关键词：
Address Affect American Ancillary Study Anxiety Benefits and Risks Cardiac Caring Cessation of life Climacteric Clinical Clinical Practice Guideline Clinical Trials Coronary Artery Bypass Coronary Vessels Coronary heart disease Country Decision Making Diabetes Mellitus Dimensions Disease Distress Enrollment Event Fatigue Foundations Funding Future Goals Health Health Surveys Infection Information Systems Infrastructure Institutes 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 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.

项目总结/文摘