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

NCT03516929 | Completed

• 1 other identifier: FMASU R 25/2018
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Diseases; Peripheral Artery Disease

Keywords

carotid; peripheral arterial disease; endarterectomy

Outcome Measures

Primary Outcomes (1)

• culprit pathology in carotid and / or lower limb duplex

  6 months

Secondary Outcomes (1)

• new cerebrovascular event or lower limb ischemia in the post operative period

  6 months

Study Arms (2)

high risk group

ACTIVE COMPARATOR

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

Diagnostic Test: carotid duplex, both LL arterial duplex

low risk group

SHAM COMPARATOR

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

Diagnostic Test: carotid duplex, both LL arterial duplex

Interventions

carotid duplex, both LL arterial duplex DIAGNOSTIC_TEST

assessment of carotid stenosis and lower limb peripheral ischemia.

high risk group; low risk group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mr Ihab Ali: lead

Study Sites (1)

Cardio-thoracic Academy -Ain-Shams University

Cairo, Egypt

Location

Related Publications (1)

• 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.

  PMID: 32993716 DERIVED

MeSH Terms

Conditions

Carotid Artery Diseases; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Cardio-thoracic Surgery at Ain-Shams University

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 7, 2018
• Study Start: August 5, 2018
• Primary Completion: April 25, 2020
• Study Completion: May 10, 2020
• Last Updated: May 26, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)