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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03516929

Enrollment

360

Registered

2018-05-07

Start date

2018-08-05

Completion date

2020-05-10

Last updated

2020-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Artery Diseases, Peripheral Artery Disease

Keywords

carotid, peripheral arterial disease, endarterectomy

Brief summary

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.

Interventions

DIAGNOSTIC_TESTcarotid duplex, both LL arterial duplex

assessment of carotid stenosis and lower limb peripheral ischemia.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. The acceptance of the patients to participate in the study in the form of a written consent. 2. Patients of both sexes. 3. Three vessels disease for CABG. 4. Patients' age: from 35 to 75 years old. 5. Elective, isolated, primary cases of CABG. 6. Patients with ejection fraction above 40%. 7. Inclusion criteria for the high-risk group will include: 1. 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. 2. Carotid bruit 3. Left main stem coronary artery disease 4. Presence of other peripheral vascular disease

Exclusion criteria

1. Patients refusing to participate in the study. 2. Age 76 years or above 3. Morbid obese patients (body mass index more than 35). 4. Patients who underwent coronary stenting before. 5. Patients who underwent previous cardiac operation before. 6. Patients with impaired renal functions (serum creatinine \> 1.5 mg/dl, blood urea \> 100 mg/dl and K+ \> 5 meq/L). 7. Patients with preoperative hemoglobin \< 9 gm/dl, white blood cells \> 15,000 cells/mcl,platelets count \< 140,000 per microliter. 8. Patients with rhythm defects by electrocardiography (ECG). 9. Patients with preoperative O2 saturation \< 90 % by pulse oximetry.

Design outcomes

Primary

Measure	Time frame
culprit pathology in carotid and / or lower limb duplex	6 months

Secondary

Measure	Time frame
new cerebrovascular event or lower limb ischemia in the post operative period	6 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026