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

Peripheral Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03516929
• Other study ID #: FMASU R 25/2018
• Status: Completed
• Phase: N/A
• Start date: August 5, 2018
• Est. completion date: May 10, 2020

Study information

• Verified date: May 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: May 10, 2020
• Est. primary completion date: April 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carotid Artery Diseases
• Carotid Stenosis
• Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Diagnostic Test:
• carotid duplex, both LL arterial duplex
assessment of carotid stenosis and lower limb peripheral ischemia.

Locations

Country	Name	City	State
Egypt	Cardio-thoracic Academy -Ain-Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Mr Ihab Ali

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	culprit pathology in carotid and / or lower limb duplex		6 months
Secondary	new cerebrovascular event or lower limb ischemia in the post operative period		6 months