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

Primary Purpose

Carotid Artery Diseases, Peripheral Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
carotid duplex, both LL arterial duplex
Sponsored by
Mr Ihab Ali
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Carotid Artery Diseases focused on measuring carotid, peripheral arterial disease, endarterectomy

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cardio-thoracic Academy -Ain-Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

high risk group

low risk group

Arm Description

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

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

Outcomes

Primary Outcome Measures

culprit pathology in carotid and / or lower limb duplex

Secondary Outcome Measures

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

Full Information

First Posted
April 24, 2018
Last Updated
May 22, 2020
Sponsor
Mr Ihab Ali
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1. Study Identification

Unique Protocol Identification Number
NCT03516929
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
August 5, 2018 (Actual)
Primary Completion Date
April 25, 2020 (Actual)
Study Completion Date
May 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mr Ihab Ali

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Diseases, Peripheral Artery Disease
Keywords
carotid, peripheral arterial disease, endarterectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high risk group
Arm Type
Active Comparator
Arm Description
history of stroke or TIA, carotid bruit, left main stem disease, other peripheral vascular disease
Arm Title
low risk group
Arm Type
Sham Comparator
Arm Description
No history or stroke,TIA. NO left main stem disease
Intervention Type
Diagnostic Test
Intervention Name(s)
carotid duplex, both LL arterial duplex
Intervention Description
assessment of carotid stenosis and lower limb peripheral ischemia.
Primary Outcome Measure Information:
Title
culprit pathology in carotid and / or lower limb duplex
Time Frame
6 months
Secondary Outcome Measure Information:
Title
new cerebrovascular event or lower limb ischemia in the post operative period
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Cardio-thoracic Academy -Ain-Shams University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32993716
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.
Results Reference
derived

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

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