Functional Recovery After Coronary Artery Bypass Graft Surgery in Frail Patients: Randomized Clinical Trial Between Minithoracotomy Versus Sternotomy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 194
- 主要终点
- Change From Baseline in the SF-36 Physical Component Summary Score at 30 Days
研究概览
简要总结
Frailty is a major predictor of adverse outcomes following coronary artery bypass grafting (CABG), being associated with increased postoperative complications, prolonged hospitalization, delayed functional recovery, and reduced quality of life. Although minimally invasive coronary surgery (MICS) through left minithoracotomy has been associated with reduced surgical trauma and faster recovery in selected patients, its benefits have not been evaluated in a randomized trial specifically involving frail patients.
The MINI FRAGILE trial is a prospective, multicenter, randomized, open-label clinical trial designed to compare minimally invasive CABG performed through left anterior minithoracotomy with conventional median sternotomy in patients aged 60 years or older with pre-frailty or frailty undergoing surgical coronary revascularization. Eligible participants will be randomized in a 1:1 ratio to either surgical approach.
The primary objective is to determine whether minimally invasive CABG improves functional recovery, assessed by the change in the physical component of the SF-36 Health Survey 30 days after surgery. Secondary outcomes include major adverse cardiovascular events, mortality, intensive care unit and hospital length of stay, duration of mechanical ventilation, return to usual activities, surgical site infection, perioperative complications, postoperative pain, readmission, and adherence to enhanced recovery measures. The results of this trial are expected to provide high-quality evidence regarding the optimal surgical approach for frail patients requiring coronary artery bypass grafting.
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
- None
盲法说明
Because of the nature of the surgical interventions, neither participants nor treating clinicians can be blinded to treatment allocation. Patient-reported quality-of-life assessments and clinical outcomes will be collected according to standardized study procedures.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 years or older.
- •Diagnosis of coronary artery disease with an established indication for coronary artery bypass grafting.
- •Coronary anatomy considered suitable for complete surgical revascularization through a left anterolateral minithoracotomy, including suitable distal coronary targets with a luminal diameter of at least 1.5 mm.;
- •> Alternatively, coronary anatomy suitable for a planned hybrid revascularization strategy, with coronary territories not treated surgically considered amenable to percutaneous coronary intervention.
- •Presence of pre-frailty or frailty, defined by at least 2 of the following Fried frailty criteria:
- •Unintentional weight loss of at least 4.5 kg or at least 5% of body weight during the previous year.
- •Self-reported exhaustion or fatigue.
- •Reduced handgrip strength.
- •Slow walking speed.
- •Low level of physical activity.
- •Ability and willingness to provide written informed consent.
排除标准
- •Requirement for emergency cardiac surgery.
- •Planned concomitant cardiac surgical procedure in addition to coronary artery bypass grafting.
- •Clinically significant peripheral vascular disease involving the femoral vessels that prevents safe peripheral cannulation for cardiopulmonary bypass, when peripheral cannulation may be required.
- •Contraindication to left minithoracotomy, including pleural adhesions, pleural thickening, or other thoracic conditions that prevent safe access to the mediastinum through the intercostal space.
- •Severe chronic obstructive pulmonary disease or another pulmonary condition that prevents safe single-lung ventilation or temporary compression of the left lung.
研究组 & 干预措施
Conventional Coronary Artery Bypass Grafting
Participants undergo conventional coronary artery bypass grafting through median sternotomy with or without cardiopulmonary bypass according to institutional practice. Postoperative care follows standard institutional protocols.
干预措施: Conventional Coronary Artery Bypass Grafting (Median Sternotomy) (Procedure)
Minimally Invasive Coronary Artery Bypass Grafting (MICS)
Participants undergo coronary artery bypass grafting through a left anterior minithoracotomy with or without cardiopulmonary bypass, according to the surgical plan. Standardized perioperative enhanced recovery measures are applied.
干预措施: Minimally Invasive Coronary Artery Bypass Grafting (MICS-CABG) (Procedure)
结局指标
主要结局
Change From Baseline in the SF-36 Physical Component Summary Score at 30 Days
时间窗: 30 days
The Short Form-36 Health Survey, version 2 (SF-36v2), will be administered before surgery and 30 days after surgery. The primary outcome is the change in the Physical Component Summary score, calculated as the 30-day score minus the baseline score. SF-36 scores are transformed to a 0-to-100 scale, with higher scores indicating better self-reported physical health and functioning.
次要结局
- Postoperative Angina(Up to 30 days after surgery)
- Incidence of Major Adverse Cardiovascular and Cerebrovascular Events(Up to 30 days after surgery)
- All-Cause Mortality(Up to 30 days after surgery)
- Perioperative Myocardial Infarction(Up to 30 days after surgery)
- Stroke(Up to 30 days after surgery)
- Repeat Coronary Revascularization(Up to 30 days after surgery)
- Duration of Mechanical Ventilation(Up to 30 days after surgery)
- Prolonged Mechanical Ventilation(Up to 30 days after surgery)
- Intensive Care Unit Length of Stay(Up to 30 days after surgery)
- Hospital Length of Stay(Up to 30 days after surgery)
- Time to Return to Usual Activities(Up to 30 days after surgery)
- Postoperative Pain Intensity(Postoperative days 1, 2, and 3)
- Deep Surgical Site Infection(Up to 30 days after surgery)
- Acute Kidney Injury(Up to 48 hours after surgery)
- Reoperation(Up to 30 days after surgery)
- Conversion to Median Sternotomy(Intraoperative period)
- Complete Coronary Revascularization(Intraoperative period)
- Adherence to Enhanced Recovery Measures(From hospital admission to 6 hours after admission to postoperative intensive care unit)
- Extubation Within 6 Hours(Up to 6 hours after intensive care unit admission)
- All-Cause Hospital Readmission(Up to 30 days after surgery)
- Short Hospital Stay(Up to 6 days after surgery)
- Prolonged Hospital Stay(Up to 14 days after surgery)