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

NCT ID: NCT06069986

Last Updated: 2023-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-10

Study Completion Date

2024-07-10

Brief Summary

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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

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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on pump CABG

using cardiopulmonary bypass

Group Type ACTIVE_COMPARATOR

coronary artery bypass graft CABG

Intervention Type PROCEDURE

comparison between onpump and off pump CABG

off pump CABG

without cardiopulmonary bypass

Group Type ACTIVE_COMPARATOR

coronary artery bypass graft CABG

Intervention Type PROCEDURE

comparison between onpump and off pump CABG

Interventions

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coronary artery bypass graft CABG

comparison between onpump and off pump CABG

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* fair and impaired EF

Exclusion Criteria

* malignancy
* COPD
* renal failure on dialysis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Ziad Essam Ahmed

assistant lecturer cardithoracic surgery sohag university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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zeyad e ahmad, assistant lecutrer

Role: CONTACT

01021301690

ayman M abdel gaffar

Role: CONTACT

Facility Contacts

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Magdy M Amin, professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 22449296 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12963202 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26725715 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28813218 (View on PubMed)

Other Identifiers

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Soh-Med-23-09-1MD

Identifier Type: -

Identifier Source: org_study_id

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