Protocol for Development and Implementation of the Saudi CABG Audit and Registry: A Prospective National Clinical Registry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,000
- 主要终点
- Incidence of In-hospital mortality
研究概览
简要总结
The Saudi CABG Audit and Registry (SCAR) is a prospective, multicenter national clinical quality registry designed to systematically collect perioperative and long-term outcome data for all patients undergoing coronary artery bypass grafting (CABG) in Saudi Arabia. The registry will begin with a pilot phase in selected tertiary cardiac centers and will progressively expand to national coverage. SCAR captures detailed information on patient demographics, cardiac status, operative techniques, postoperative outcomes, and 1-year follow-up, including patient-reported quality-of-life measures (EQ-5D and SF-36). The aim is to establish a standardized national platform for benchmarking, quality improvement, and real-world evidence generation to support clinical decision-making and health policy development in cardiac surgery. Data are collected prospectively through secure electronic systems, anonymized before central storage, and analyzed using standardized definitions aligned with international registries such as STS and E-CABG.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 years or older
- •Undergoing isolated CABG
- •Undergoing CABG with concomitant procedures (e.g., valve repair or replacement)
- •Undergoing on-pump, off-pump, minimally invasive, or robotic CABG
- •Procedures performed electively, urgently, or emergently
排除标准
- •Redo CABG when the primary operative record is not available
- •Patients younger than 18 years
结局指标
主要结局
Incidence of In-hospital mortality
时间窗: From date of surgery through hospital discharge, an average of 7-10 days.
In-hospital all-cause mortality following coronary artery bypass grafting (CABG), recorded from the time of surgery until discharge. Mortality will be determined using standardized definitions aligned with major cardiac surgery registries such as STS and E-CABG.
Incidence of 30-day major adverse cardiac and cerebrovascular events (MACCE)
时间窗: 30 days post-surgery
Composite endpoint including 30-day all-cause mortality, stroke, and myocardial infarction after coronary artery bypass grafting (CABG). Event definitions follow standardized criteria used in major cardiac surgery registries, including STS and E-CABG.
Incidence of Deep sternal wound infection (DSWI)
时间窗: From surgery until 30 days post-operation
Incidence of deep sternal wound infection following coronary artery bypass grafting (CABG), defined according to Centers for Disease Control and Prevention (CDC) criteria. Includes infections involving muscle, bone, or mediastinum requiring surgical intervention, antibiotics, or drainage.
Unplanned reoperation for bleeding, tamponade, or graft-related technical failure
时间窗: Perioperative/Periprocedural
Incidence of unplanned return to the operating room after coronary artery bypass grafting (CABG) due to postoperative bleeding, cardiac tamponade, or graft-related technical failure. Events follow standardized definitions aligned with international cardiac surgery registries.
次要结局
- Duration of mechanical ventilation(From completion of surgery through extubation, an average of 12-24 hours)
- Incidence of 30-day readmission(Within 30 days post-discharge)
- One-year survival(1 year post-surgery)
- Intensive care unit (ICU) length of stay(From the date of surgery through initial ICU discharge (average of 3-5 days).)
- Total hospital length of stay(From the date of surgery through hospital discharge (average of 7-10 days).)
- Number of Participants with Post Operative Acute kidney injury (AKI)(From date of surgery through hospital discharge, an average of 7-10 days.)
- Number of Participants with post operative New-onset atrial fibrillation(From date of surgery through hospital discharge, an average of 7-10 days.)
- Return to work or usual activity(1 year post-surgery)
- Incidence of New renal replacement therapy Initiation(From date of surgery through hospital discharge, an average of 7-10 days.)
- EuroQol-5 Dimension (EQ-5D)(Baseline, 6 months, 1 year)
- Blood product utilization(Intraoperative through 24 hours post-surgery)
- One-year MACCE(1 year post-surgery)
- Short Form Health Survey (SF-36)(Baseline, 6 months, and 1 year post-surgery)
研究者
Uthman Aluthman
Consultant Cardiac Surgeon
King Faisal Specialist Hospital & Research Center