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OpenTrials
Completed

NCT Number: NCT03516929

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

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.

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Key information

Conditions

Carotid Artery Diseases Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Peripheral Arterial Disease Peripheral Artery Disease Peripheral Vascular Diseases Vascular Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardio-thoracic Academy -Ain-Shams University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%.
  • Inclusion criteria for the high-risk group will include:
  • 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

Exclusion criteria

  • 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.

Treatment and study plan

carotid duplex, both LL arterial duplex

Diagnostic Test

assessment of carotid stenosis and lower limb peripheral ischemia.

Primary outcomes

  1. culprit pathology in carotid and / or lower limb duplex

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Mr Ihab Ali

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 7, 2018
Registry last updated
May 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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