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

NCT06069986 | Unknown

• 1 other identifier: Soh-Med-23-09-1MD
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

on pump CABG

ACTIVE COMPARATOR

using cardiopulmonary bypass

Procedure: coronary artery bypass graft CABG

off pump CABG

ACTIVE COMPARATOR

without cardiopulmonary bypass

Procedure: coronary artery bypass graft CABG

Interventions

coronary artery bypass graft CABG PROCEDURE

comparison between onpump and off pump CABG

off pump CABG; on pump CABG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• fair and impaired EF

You may not qualify if:

• malignancy
• COPD
• renal failure on dialysis

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 22449296 BACKGROUND

• 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.

  PMID: 12963202 BACKGROUND

• 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.

  PMID: 26725715 BACKGROUND

• 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.

  PMID: 28813218 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Central Study Contacts

zeyad e ahmad, assistant lecutrer

CONTACT

01021301690; Ziad.assem@med.sohag.edu.eg

ayman M abdel gaffar

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer cardithoracic surgery sohag university

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: October 6, 2023
• Study Start: July 10, 2023
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-10

Locations

EG (1)