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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05300178
Other study ID # coronary revascularization
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 22, 2022
Est. completion date March 22, 2022

Study information

Verified date March 2022
Source Assiut University
Contact ahmed s youssef, M.D
Phone 01002378685
Email drahmed.samir225@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date March 22, 2022
Est. primary completion date March 22, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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 Design


Intervention

Procedure:
coronary artery bypass grafting surgery
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (5)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Effective revascularization. Changes Baseline perfustion after 3 months by MRI
Secondary Number of patient complicated by heart failure changes in the base line heart rate after 24 hours post-operative
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