- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05442723
Extensively Diseased Left Anterior Descending Coronary Artery: On Pump vs Off Pump CABG?
June 28, 2022 updated by: Kareem Ahmed Hosny, Assiut University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt, 2112
- Recruiting
- Assiut university heart hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Case
Patients with extensive LAD disease treated with off-pump CABG
|
coronary artery grafting by beating heart technique
|
Other: Control
Patients with extensive LAD disease treated with on-pump CABG
|
coronary artery grafting by using cardiopulmonary bypass machine
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mortality
Time Frame: 30 days post operative
|
follow up post-operative track of the patient for any noticed mortality rate
|
30 days post operative
|
Morbidity
Time Frame: 60 days post operative
|
follow up post-operative track of the patient for any noticed complications
|
60 days post operative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 25, 2022
Primary Completion (Anticipated)
February 24, 2023
Study Completion (Anticipated)
March 1, 2023
Study Registration Dates
First Submitted
February 26, 2022
First Submitted That Met QC Criteria
June 28, 2022
First Posted (Actual)
July 5, 2022
Study Record Updates
Last Update Posted (Actual)
July 5, 2022
Last Update Submitted That Met QC Criteria
June 28, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AssiutMed
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of WuerzburgDeutsche Stiftung für HerzforschungUnknownStroke | Coronary Heart Disease | Cerebral InfarctionGermany
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University of Sao Paulo General HospitalMount Sinai Hospital, New York; Beneficência Portuguesa de São Paulo; Instituto... and other collaboratorsRecruitingCoronary Artery Disease | Frail ElderlyUnited States, Brazil
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Population Health Research InstituteCharles University, Czech Republic; Centre hospitalier de l'Université de Montréal... and other collaboratorsCompletedthe Efficacy and Safety of Off-pump CABGCanada, China, Colombia, India, Chile, Argentina, Brazil, Czech Republic, France, Italy, Poland, Turkey, United Kingdom