Coronary Artery DiseaseNCT06069986
On-pump Versus Off-pump Coronary Artery Bypass Grafting , Short Term Outcomes , Sohag Experience
A study testing coronary artery bypass graft CABG in people with Coronary Artery Disease, run by Sohag University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- coronary artery bypass graft CABG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2023to 10 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- fair and impaired EF
Who cannot join
- malignancy
- COPD
- renal failure on dialysis
Trial locations and contacts
1 site in 1 country.
ayman M abdel gaffar contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, professor
About this study
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.
Read more
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
- Being tested
- coronary artery bypass graft CABG
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary artery bypass graft CABGProcedure or surgery
comparison between onpump and off pump CABG
| Study group | Role | What they receive |
|---|---|---|
| on pump CABG | Active comparator | using cardiopulmonary bypass Receives: Procedure: coronary artery bypass graft CABG |
| off pump CABG | Active comparator | without cardiopulmonary bypass Receives: Procedure: coronary artery bypass graft CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start10 Jul 2023
- Primary completion10 Jul 2024 (estimated)
- Study completion10 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziad Essam Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069986
- Sponsor's protocol ID
- Soh-Med-23-09-1MD
- Status last verified
- Oct 2023
- First submitted
- 13 Sep 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22449296Ascione 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.
PubMed 12963202Ueki 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.
PubMed 26725715Shroyer 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.
PubMed 28813218
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On-pump Versus Off-pump Coronary Artery Bypass Grafting , Short Term Outcomes , Sohag Experience
- ClinicalTrials.gov ID
- NCT06069986
- Acronym / sponsor ID
- Soh-Med-23-09-1MD
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 10 Jul 2024 (estimated)
- Study completion
- 10 Jul 2024 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| on pump CABG | Active comparator | Procedure: coronary artery bypass graft CABGusing cardiopulmonary bypass |
| off pump CABG | Active comparator | Procedure: coronary artery bypass graft CABGwithout cardiopulmonary bypass |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- fair and impaired EF
Key exclusion criteria (3 listed)
- malignancy
- COPD
- renal failure on dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary artery bypass graft CABGcomparison between onpump and off pump CABG | Procedure or surgery | off pump CABG, on pump CABG |
Primary outcome
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
Time frame: 1 year
which is better in morbidity and mortality, on pump or off pump CABG specially in patients with low ejection fraction (less than 40%)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Background: PubMed 22449296Lamy 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.
- Background: PubMed 12963202Ascione 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.
- Background: PubMed 26725715Ueki 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.
- Background: PubMed 28813218Shroyer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ayman M abdel gaffar contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coronary artery bypass graft CABG in people with Coronary Artery Disease, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zeyad e ahmad, assistant lecutrer (01021301690, Ziad.assem@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06069986, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.