Assessment of Carotid Artery Stenosis and Lower Limb Peripheral Ischemia Prior to CABG

Study Overview
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Brief Summary
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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.

Official Title
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Non-selective Assessment of Carotid Artery Stenosis and Lower Limb Peripheral Ischemia Prior to Coronary Artery Bypass Surgery

Conditions
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Carotid Artery Diseases, Peripheral Artery Disease

Intervention / Treatment
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* Diagnostic Test: carotid duplex, both LL arterial duplex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: high risk group<br>history of stroke or TIA, carotid bruit, left main stem disease, other peripheral vascular disease | Diagnostic Test: carotid duplex, both LL arterial duplex<br>* assessment of carotid stenosis and lower limb peripheral ischemia.<br>|
| Sham Comparator: low risk group<br>No history or stroke,TIA. NO left main stem disease | Diagnostic Test: carotid duplex, both LL arterial duplex<br>* assessment of carotid stenosis and lower limb peripheral ischemia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| culprit pathology in carotid and / or lower limb duplex |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| new cerebrovascular event or lower limb ischemia in the post operative period |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carotid, peripheral arterial disease, endarterectomy