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

Mr Ihab Ali

Status: Completed

Conditions: Peripheral Artery Disease; Carotid Artery Diseases

Treatments: Diagnostic Test: carotid duplex, both LL arterial duplex

Study type: Interventional

Funder types: Other

Identifiers

NCT03516929

FMASU R 25/2018

Details and patient eligibility

About

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.

Enrollment: 360 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 2 patient groups

high risk group

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: carotid duplex, both LL arterial duplex

low risk group

Sham Comparator group

Description:

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

Treatment:

Diagnostic Test: carotid duplex, both LL arterial duplex