On-pump Versus Off-pump Coronary Artery Bypass Grafting , Short Term Outcomes , Sohag Experience

Coronary Artery Disease Clinical Trial

Official title:

On-pump Versus Off-pump Coronary Artery Bypass Grafting , Short Term Outcomes , Sohag Experience

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06069986
• Other study ID #: Soh-Med-23-09-1MD
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2023
• Est. completion date: July 10, 2024

Study information

• Verified date: October 2023
• Source: Sohag University
• Contact: zeyad e ahmad, assistant lecutrer
• Phone: 01021301690
• Email: Ziad.assem[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Coronary artery disease (CAD) and its sequlae, such as myocardial infarction, arrhythmia and heart failure, are among the leading causes of death around the world . the durable role of coronary artery bypass grafting (CABG) in the treatment of CAD has long been shown.

Coronary artery bypass grafting (CABG) is a commonly performed surgical procedure for patients with coronary artery disease (CAD), CABG can be performed using either the on-pump or off-pump technique, each with its own advantages and limitations.

On-pump CABG involves the use of CPB which as agold standard for surgical coronary revascularization has led toexcellent results in mortality and complications. On-pump CABG allows the surgeon to temporarily stop the heart and provide perfusion and oxygenation to the body. This technique provides a bloodless and motionless operative field, allowing for precise graft anastomosis. However, the use of CPB is associated with deleterious effects as systemic inflammatory response, hemodilution, and organ dysfunction as dysrhythmia and neurocognitive problems. These factors may adversely affect patients lives specially those with impaired EF, who already have compromised cardiovascular function.

Another technique for CABG is on-pump beating heart CABG (ONBH-CABG) surgery that is relatively novel hybrid approach to coronary artery grafting which aims to stabilize hemodynamic parameters during the operative period. This has specific benefits such as reduced preload alongside the afterload which decreases the oxygen demand of the myocardial tissue

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 10, 2024
• Est. primary completion date: July 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• fair and impaired EF

Exclusion Criteria:

• malignancy

• COPD

• renal failure on dialysis

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• coronary artery bypass graft CABG
comparison between onpump and off pump CABG

Locations

Country	Name	City	State
Egypt	Sohag university Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Ascione R, Narayan P, Rogers CA, Lim KH, Capoun R, Angelini GD. Early and midterm clinical outcome in patients with severe left ventricular dysfunction undergoing coronary artery surgery. Ann Thorac Surg. 2003 Sep;76(3):793-9. doi: 10.1016/s0003-4975(03)00664-7. — View Citation

Lamy A, Devereaux PJ, Prabhakaran D, Taggart DP, Hu S, Paolasso E, Straka Z, Piegas LS, Akar AR, Jain AR, Noiseux N, Padmanabhan C, Bahamondes JC, Novick RJ, Vaijyanath P, Reddy S, Tao L, Olavegogeascoechea PA, Airan B, Sulling TA, Whitlock RP, Ou Y, Ng J, Chrolavicius S, Yusuf S; CORONARY Investigators. Off-pump or on-pump coronary-artery bypass grafting at 30 days. N Engl J Med. 2012 Apr 19;366(16):1489-97. doi: 10.1056/NEJMoa1200388. Epub 2012 Mar 26. — View Citation

Shroyer AL, Hattler B, Wagner TH, Collins JF, Baltz JH, Quin JA, Almassi GH, Kozora E, Bakaeen F, Cleveland JC Jr, Bishawi M, Grover FL; Veterans Affairs ROOBY-FS Group. Five-Year Outcomes after On-Pump and Off-Pump Coronary-Artery Bypass. N Engl J Med. 2017 Aug 17;377(7):623-632. doi: 10.1056/NEJMoa1614341. — View Citation

Ueki C, Miyata H, Motomura N, Sakaguchi G, Akimoto T, Takamoto S. Off-pump versus on-pump coronary artery bypass grafting in patients with left ventricular dysfunction. J Thorac Cardiovasc Surg. 2016 Apr;151(4):1092-8. doi: 10.1016/j.jtcvs.2015.11.023. Epub 2015 Nov 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison to declare the rate of morbidity and mortality using both techniques on pump and off pump in CABG and which is better in short term outcomes	which is better in morbidity and mortality, on pump or off pump CABG specially in patients with low ejection fraction (less than 40%)	1 year