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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-05

Study Completion Date

2020-05-10

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.

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Detailed Description

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Conditions

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Carotid Artery Diseases Peripheral Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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high risk group

history of stroke or TIA, carotid bruit, left main stem disease, other peripheral vascular disease

Group Type ACTIVE_COMPARATOR

carotid duplex, both LL arterial duplex

Intervention Type DIAGNOSTIC_TEST

assessment of carotid stenosis and lower limb peripheral ischemia.

low risk group

No history or stroke,TIA. NO left main stem disease

Group Type SHAM_COMPARATOR

carotid duplex, both LL arterial duplex

Intervention Type DIAGNOSTIC_TEST

assessment of carotid stenosis and lower limb peripheral ischemia.

Interventions

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carotid duplex, both LL arterial duplex

assessment of carotid stenosis and lower limb peripheral ischemia.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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%.

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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No