Back to resultsExtensively Diseased Left Anterior Descending Coronary Artery: On Pump vs Off Pump CABG?
Primary Purpose
CAD - Coronary Artery Disease
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
On-Pump CABG
Off-Pump CABG
Sponsored by
About this trial
This is an interventional treatment trial for CAD - Coronary Artery Disease focused on measuring On-pump, off-pump, CABG, LAD
Eligibility Criteria
Inclusion Criteria:
- any patient with diffuse LAD disease indicated for open heart surgery
Exclusion Criteria:
- no concomitant valve disease
- any patient can be treated by medical treatment or PCI
Sites / Locations
- Assiut university heart hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Case
Control
Arm Description
Patients with extensive LAD disease treated with off-pump CABG
Patients with extensive LAD disease treated with on-pump CABG
Outcomes
Primary Outcome Measures
mortality
follow up post-operative track of the patient for any noticed mortality rate
Morbidity
follow up post-operative track of the patient for any noticed complications
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05442723
Brief Title
Extensively Diseased Left Anterior Descending Coronary Artery: On Pump vs Off Pump CABG?
Official Title
Extensively Diseased Left Anterior Descending Coronary Artery: On Pump vs Off Pump CABG?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2022 (Actual)
Primary Completion Date
February 24, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Diseased left Anterior descending coronary artery (LAD) is one of the most challenging conditions in Bypass surgery. we investigate whether on-pump coronary artery bypass grafting (CABG) is more beneficial in those critical patients or off-pump surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CAD - Coronary Artery Disease
Keywords
On-pump, off-pump, CABG, LAD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Case
Arm Type
Other
Arm Description
Patients with extensive LAD disease treated with off-pump CABG
Arm Title
Control
Arm Type
Other
Arm Description
Patients with extensive LAD disease treated with on-pump CABG
Intervention Type
Procedure
Intervention Name(s)
On-Pump CABG
Other Intervention Name(s)
CABG
Intervention Description
coronary artery grafting by using cardiopulmonary bypass machine
Intervention Type
Procedure
Intervention Name(s)
Off-Pump CABG
Intervention Description
coronary artery grafting by beating heart technique
Primary Outcome Measure Information:
Title
mortality
Description
follow up post-operative track of the patient for any noticed mortality rate
Time Frame
30 days post operative
Title
Morbidity
Description
follow up post-operative track of the patient for any noticed complications
Time Frame
60 days post operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
any patient with diffuse LAD disease indicated for open heart surgery
Exclusion Criteria:
no concomitant valve disease
any patient can be treated by medical treatment or PCI
Facility Information:
Facility Name
Assiut university heart hospital
City
Assiut
ZIP/Postal Code
2112
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kareem Ahmed Hosny, Bachelor of medicine
Phone
01000401994
Email
kareemdna94@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Extensively Diseased Left Anterior Descending Coronary Artery: On Pump vs Off Pump CABG?
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