Non-selective Assessment of Carotid Artery Stenosis and Lower Limb Peripheral Ischemia Prior to Coronary Artery Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- culprit pathology in carotid and / or lower limb duplex
研究概览
简要总结
From our experience among Egyptian population in our institution, there is an increased prevalence of hidden subclinical peripheral artery disease along with carotid artery affection. Thus, increasing the risk of post-operative morbid complications.We aim to evaluate routine/ non-selective carotid and peripheral arterial screening in asymptomatic patients undergoing coronary artery bypass grafting in the Egyptian populationIt is a prospective, non-randomized, comparative study including two groups of patients. The study will start from the day of approval of the ethical committee. It will include 260 patients, on basis of "all new comers". Patients will be examined and classified as "high-risk" group (ɳ = 130) or "low-risk" group (ɳ=130).
All patients will have the "routine" preoperative investigations along with evaluation of extracranial carotid system by non-invasive carotid duplex and lower limb arterial system by non-invasive bilateral lower limb arterial duplex.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The acceptance of the patients to participate in the study in the form of a written consent.
- •Patients of both sexes.
- •Three vessels disease for CABG.
- •Patients' age: from 35 to 75 years old.
- •Elective, isolated, primary cases of CABG.
- •Patients with ejection fraction above 40%.
- •Inclusion criteria for the high-risk group will include:
- •Patients with preoperative history of cerebrovascular events or symptoms suggestive of CVS eg.TIA, transient blindness in one eye, Dizziness, Confusion, Drowsiness, Headache, Temporary inability to speak or move.
- •Carotid bruit
- •Left main stem coronary artery disease
- •Presence of other peripheral vascular disease
排除标准
- •Patients refusing to participate in the study.
- •Age 76 years or above
- •Morbid obese patients (body mass index more than 35).
- •Patients who underwent coronary stenting before.
- •Patients who underwent previous cardiac operation before.
- •Patients with impaired renal functions (serum creatinine > 1.5 mg/dl, blood urea > 100 mg/dl and K+ > 5 meq/L).
- •Patients with preoperative hemoglobin < 9 gm/dl, white blood cells > 15,000 cells/mcl,platelets count < 140,000 per microliter.
- •Patients with rhythm defects by electrocardiography (ECG).
- •Patients with preoperative O2 saturation < 90 % by pulse oximetry.
结局指标
主要结局
culprit pathology in carotid and / or lower limb duplex
时间窗: 6 months
次要结局
- new cerebrovascular event or lower limb ischemia in the post operative period(6 months)
研究者
Mr Ihab Ali
Assistant Professor of Cardio-thoracic Surgery at Ain-Shams University
Ain Shams University