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

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.

Study Overview

• Status: Completed
• Conditions: Carotid Artery Diseases; Peripheral Artery Disease
• Intervention / Treatment: Diagnostic test: carotid duplex, both LL arterial duplex

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cardio-thoracic Academy -Ain-Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mr Ihab Ali

Publications and helpful links

General Publications

• Ali I, Shokri H, Abd Al Jawad M. Assessment of carotid artery stenosis and lower limb peripheral ischemia before coronary artery bypass grafting operations: a non-randomized clinical trial. J Cardiothorac Surg. 2020 Sep 29;15(1):283. doi: 10.1186/s13019-020-01340-7.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2018
• Primary Completion (Actual): April 25, 2020
• Study Completion (Actual): May 10, 2020

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: April 24, 2018
• First Posted (Actual): May 7, 2018

Study Record Updates

• Last Update Posted (Actual): May 26, 2020
• Last Update Submitted That Met QC Criteria: May 22, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: peripheral arterial disease; carotid; endarterectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Ischemia; Peripheral Arterial Disease; Carotid Stenosis; Carotid Artery Diseases
• Other Study ID Numbers: FMASU R 25/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No