Randomized Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women (ROMA:Women) Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,300
- 试验地点
- 141
- 主要终点
- Primary outcome for aim 2: Disease-specific quality of life
研究概览
简要总结
The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grafting (SAG).
The specific aims of ROMA:Women are:
Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grafting (CABG). The investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,300 women randomized 1:1 to MAG or SAG. Differences by important clinical and surgical subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women, increasing efficiency and reducing enrollment time.
Hypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events.
Hypothesis 1.1. The improvement with MAG will be consistent across key subgroups.
Aim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and mental health symptoms in women undergoing CABG. The investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above) will also be evaluated.
Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG.
Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG.
Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.
详细描述
ROMA:Women will leverage the infrastructure and the existing women population of the ROMA trial. ROMA:Women has two key Aims. In Aim 1, the investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,300 women randomized 1:1 to MAG or SAG. In Aim 2, the investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG. Differences by important subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated.
ROMA:Women is a two-arm, international, multi-center, randomized clinical trial nested in the ROMA trial. ROMA:Women will include all the women enrolled in the parent ROMA trial and will leverage the existing ROMA infrastructure including clinical trial unit, database, case report forms (CRF), randomization system, site training resources, informed consent forms (ICF), regulatory approvals, Central Events Review Committee (CEC) processes/personnel, network of participating sites, site PIs, and study coordinators. The planned randomization procedure, interventions and treatment arms, outcome assessments and follow-up protocol of ROMA:Women are identical to those of the currently ongoing parent ROMA trial. The sites participating in ROMA will continue enrollment of women after the completion of the ROMA trial and additional sites will also be opened to reach the target sample size of ROMA:Women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The endpoint assessors will be blinded to treatment allocation (PROBE).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women patients ≥18 years old.
- •Isolated coronary artery bypass grafting.
- •Primary (first time) cardiac surgery procedure.
- •Significant disease of the left main coronary artery or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery.
排除标准
- •Male gender
- •Single graft
- •Emergency operation
- •Myocardial infarction within 72 hours of surgery
- •Left ventricular ejection fraction < 35%
- •Any concomitant cardiac or non-cardiac procedure
- •Previous cardiac surgery
- •Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure), cancer or any co-morbidity that reduces life expectancy to less than 5 years.
- •Inability to use the saphenous vein or to use both radial and right internal thoracic arteries
- •Anticipated need for coronary thrombo-endarterectomy
- •Planned hybrid revascularization
研究组 & 干预措施
Single Arterial Graft (SAG) group
Patients in this group will receive a single arterial graft which will be the left internal thoracic artery. Additional grafts used in this group will all be venous grafts.
干预措施: Single arterial graft (Procedure)
Multiple Arterial Graft (MAG) group
Patients in the group will receive multiple arterial grafts. All patients will receive at least two arterial grafts, the left internal thoracic artery with the addition of either the right internal thoracic artery or the radial artery as the second conduit. Some patients may receive additional arterial grafts consisting of the radial artery, the right internal thoracic artery, or the right gastroepiploic artery.
干预措施: Multiple arterial grafting (Procedure)
结局指标
主要结局
Primary outcome for aim 2: Disease-specific quality of life
时间窗: Postoperatively, minimum 2.5 year follow-up
Assessed using the Seattle Angina Questionnaire (SAQ), a validated 19-item questionnaire that measures five domains related to coronary disease: angina frequency, physical limitations, quality of life, angina stability, and treatment satisfaction. Scores range from 0 to 100 with higher scores indicating fewer symptoms and better health status. The minimum clinically important difference on the SAQ is 5 points. The primary endpoint for aim 2 is the absolute change in the Seattle Angina Questionnaire (SAQ) at 12 months compared to baseline.
Primary outcome for aim 1: Death from any cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.
时间窗: Postoperatively, minimum 2.5 year follow-up
The primary outcome for aim 1 will be a composite of the first occurrence of death from any cause, any stroke, non-procedural myocardial infarction (\>48 hours after surgery), repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.
次要结局
- Mental and physical health symptoms according to PROMIS instruments(Postoperatively, minimum 2.5 year follow-up)
- Generic quality of life according to EuroQuol-5D (EQ-5D)(Postoperatively, minimum 2.5 year follow-up)
- Death from any cause(Postoperatively, minimum 2.5 year follow-up)
- Readmission for acute coronary syndrome(Postoperatively, minimum 2.5 year follow-up)
- Readmission for heart failure(Postoperatively, minimum 2.5 year follow-up)
- Generic quality of life according to the Short Form Health Survey (SF-12v2)(Postoperatively, minimum 2.5 year follow-up)
- Stroke(Postoperatively, minimum 2.5 year follow-up)
- Repeat revascularization(Postoperatively, minimum 2.5 year follow-up)
- Death from any cause, any stroke, non-procedural myocardial infarction, and repeat revascularization.(Postoperatively, minimum 2.5 year follow-up)
- Death from cardiac cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.(Postoperatively, minimum 2.5 year follow-up)
- Non-procedural myocardial infarction(> 48 hours postoperatively, minimum 2.5 year follow-up)