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

Sponsor

Mr Ihab Ali (Other)

Overall Status

Completed

CT.gov ID

NCT03516929

Collaborator

(none)

360

Enrollment

Location

Arms

21.2

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Diseases Peripheral Artery Disease	Diagnostic Test: carotid duplex, both LL arterial duplex	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 5, 2018

Actual Primary Completion Date :

Apr 25, 2020

Actual Study Completion Date :

May 10, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: high risk group

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

Diagnostic Test: carotid duplex, both LL arterial duplex

assessment of carotid stenosis and lower limb peripheral ischemia.

Sham Comparator: low risk group

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

Diagnostic Test: carotid duplex, both LL arterial duplex

assessment of carotid stenosis and lower limb peripheral ischemia.

Outcome Measures

Primary Outcome Measures

culprit pathology in carotid and / or lower limb duplex [6 months]

Secondary Outcome Measures

new cerebrovascular event or lower limb ischemia in the post operative period [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.