- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05300178
Use of Various Configurations of Different Arterial Grafts in Total Arterial Revascularization
March 18, 2022 updated by: ahmed samir yussef, Assiut University
CABG is a difficult and very critical surgery , it is done to revascularize the myocardium in cases of cardiac ischemia .
If the myocardium is still viable in selected patients then it is the treatment of choice with outstanding results .
Indications of this operation are more than 50% diameter stenosis of the left main coronary artery, more than 70% diameter stenosis in proximal left anterior descending artery (LAD), more than 70% diameter stenosis in three major coronary vessels, ventricular septal defect related to myocardial infarction , papillary muscle rupture , free wall rupture , ventricular pseudoaneurysm , life-threatening ventricular arrhythmias, and cardiogenic shock.
Multiple methods have evolved to achieve the best outcome .The revascularization process depend on two main graft either artery or venous , each has its advantage and disadvantage according to their elasticity , ability to deliver an adequate flow and sustain high blood pressure.
Our focus is on the different configuration used for the revascularization by using the artery grafts only due to the superiority of the artery graft in comparison to the venous according to the outcomes and not the feasibility of the technique .It is recommended to begin with internal thoracic artery then saphenous vein if both failed then multiple conduits will be used .
Bilateral internal thoracic artery grafting can be an optimal option for coronary artery bypass grafting ,but it's the long-term outcome is still under study.There is no accepted configuration of the anastomosis to be used in the multiple conduits .
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ahmed s youssef, M.D
- Phone Number: 01002378685
- Email: drahmed.samir225@gmail.com
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
20 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients with multi-coronary vessel disease who are indicated for CABG surgery .
Description
Inclusion Criteria:
- All patients with multi-coronary vessel disease eligible for CABG surgery .
Exclusion Criteria:
- 1. age more than 70 years 2. diabetic patient 3. single vessel disease 4. associated valvular disease 5. previous open heart surgery 6. hemodynamic unstability 7. Ejection fraction less than (40%)
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
multiple vessel disease
patients with coronary artery disease will be revascularized by using different bypass configuration.
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Strategies of Complete Arterial Revascularization THE COMPOSITE TECHNIQUE When the distal RIMA bifurcation cannot loosely reach the LAD, we use the RIMA as a free graft, and a T-shaped , or if more suitable, a Y-shaped anastomosis at the level of the main pulmonary artery, is prepared before connection to cardiopulmonary bypass (CPB) THE CROSS TECHNIQUE The cross arrangement is based on the assumption that patency rates of the right internal mammary artery (RIMA) on the left anterior descending coronary artery (LAD) is similar to that of the left internal mammary artery (LIMA) on the LAD.
To improve late survival, every effort should be made to use both IMA grafts for the left system THE IN SITU SEQUENCE When a graft to the posterior wall of the heart is not necessary (the circumflex region), the LIMA is grafted to the left anterior descending and the RIMA to the right coronary artery or its posterior de
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Effective revascularization.
Time Frame: Changes Baseline perfustion after 3 months by MRI
|
Changes Baseline perfustion after 3 months by MRI
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of patient complicated by heart failure
Time Frame: changes in the base line heart rate after 24 hours post-operative
|
changes in the base line heart rate after 24 hours post-operative
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Rocha EAV. Fifty Years of Coronary Artery Bypass Graft Surgery. Braz J Cardiovasc Surg. 2017 Jul-Aug;32(4):II-III. doi: 10.21470/1678-9741-2017-0104. No abstract available.
- Garatti A, Castelvecchio S, Canziani A, Santoro T, Menicanti L. CABG in patients with left ventricular dysfunction: indications, techniques and outcomes. Indian J Thorac Cardiovasc Surg. 2018 Dec;34(Suppl 3):279-286. doi: 10.1007/s12055-018-0738-8. Epub 2018 Oct 17.
- Amin S, Madsen PL, Werner RS, Krasopoulos G, Taggart DP. Intraoperative flow profiles of arterial and venous bypass grafts to the left coronary territory. Eur J Cardiothorac Surg. 2019 Jul 1;56(1):64-71. doi: 10.1093/ejcts/ezy473.
- Kawajiri H, Grau JB, Fortier JH, Glineur D. Bilateral internal thoracic artery grafting: in situ or composite? Ann Cardiothorac Surg. 2018 Sep;7(5):673-680. doi: 10.21037/acs.2018.05.16.
- Goldstone AB, Chiu P, Baiocchi M, Wang H, Lingala B, Boyd JH, Woo YJ. Second Arterial Versus Venous Conduits for Multivessel Coronary Artery Bypass Surgery in California. Circulation. 2018 Apr 17;137(16):1698-1707. doi: 10.1161/CIRCULATIONAHA.117.030959. Epub 2017 Dec 14.
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 (ANTICIPATED)
March 22, 2022
Primary Completion (ANTICIPATED)
March 22, 2022
Study Completion (ANTICIPATED)
March 22, 2022
Study Registration Dates
First Submitted
February 24, 2022
First Submitted That Met QC Criteria
March 18, 2022
First Posted (ACTUAL)
March 29, 2022
Study Record Updates
Last Update Posted (ACTUAL)
March 29, 2022
Last Update Submitted That Met QC Criteria
March 18, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- coronary revascularization
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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