Clinical trial NCT03516929: Assessment of Carotid Artery Stenosis and Lower Limb Peripheral Ischemia Prior to CABG
Official title: Non-selective Assessment of Carotid Artery Stenosis and Lower Limb Peripheral Ischemia Prior to Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Artery Diseases
Peripheral Artery Disease
Keywords: carotid
peripheral arterial disease
endarterectomy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-05-07
Enrollment: 360
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: culprit pathology in carotid and / or lower limb duplex
timeFrame: 6 months
Secondary outcomes:
measure: new cerebrovascular event or lower limb ischemia in the post operative period
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cardio-thoracic Academy -Ain-Shams University
Study officials:
References:
citation: 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.