- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04093817
Arrhythmia in on Pump vs. Off Pump Coronary Artery Bypass Grafting
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
On pump vs. off pump CABG has been a topic of debate for many years regarding the benefits and the risks of each technique .Off pump CABG began 30 years ago. Its promotion was based on its potential benefits over some of the limitation of traditional on pump CABG. It avoids the trauma of cardiopulmonary bypass (CPB) and minimizing aortic manipulation and reducing length of hospital stay and morbidity.
There is a criticism regarding completence of revascularization in off pump vs. on pump CABG, this is no longer valid in the current era as technology to safely perform multi vessel off pump has improved tremendously over the past decade.
One of the debates between these two techniques was the incidence of arrhythmias in and after the operation and its relation to morbidity and mortality at the operation and hospital stay after the operation.
As known atrial fibrillation (AF) is still the most common arrhythmia that occur after CABG and although in some studies it has been considered a benign and self-limiting complication, some suggest serious morbidity and mortality from this complication, it is said that it affects more than 40% of patients underwent CABG. Atrial fibrillation (AF) may lead to thromboembolic complications, additional pharmacotherapy, longer hospital stay, increase cost, anxiety and stroke.
Most AF post CABG are found in the second to third post-operative day. SO, on this study the investigators focus one the incidence of arrhythmias, especially AF in those two techniques and their relations to patients' morbidity and mortality.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mohamed Kamel, resident doctor
- Phone Number: 01149625752\01063067860
- Email: memad_505@yahoo.com
Study Contact Backup
- Name: Ali Abdelwahaab, prof.dr
- Phone Number: 01222442156
- Email: draliabdelwahab@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients subjected to CABG
Exclusion Criteria:
- Associated valvular heart disease
- Emergency cases
- Previous AF
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
on pump CABG
patients under going CABG with cardiopulmonary bypass machine
|
cardio pulmonary bypass machine is a machine that work to compensate for the function of the heart and the lungs in the operation
|
off pump CABG
patients under going CABG without cardiopulmonary bypass machine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the incidence of arrhythmias in on pump vs. off pump coronary artery bypass grafting
Time Frame: the number of episodes of arrhythmia s in one week after the operation
|
the frequency of arrhythmia s (in number of episodes) using a12-leads continuous electrocardiogram(ECG) in each type of the two operations.the
number of patients that experience those arrhythmia s (in percentage) from the total number of patients that go for those two operations.
|
the number of episodes of arrhythmia s in one week after the operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
decrease morbidity, mortality, hospital stay and hospital cost
Time Frame: baseline
|
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Samy Othman, prof.dr, Assiut University
- Study Chair: Ahmed Taha, lecturer, Assiut University
Publications and helpful links
General Publications
- Gaudino M, Angelini GD, Antoniades C, Bakaeen F, Benedetto U, Calafiore AM, Di Franco A, Di Mauro M, Fremes SE, Girardi LN, Glineur D, Grau J, He GW, Patrono C, Puskas JD, Ruel M, Schwann TA, Tam DY, Tatoulis J, Tranbaugh R, Vallely M, Zenati MA, Mack M, Taggart DP; Arterial Grafting International Consortium (ATLANTIC) Alliance. Off-Pump Coronary Artery Bypass Grafting: 30 Years of Debate. J Am Heart Assoc. 2018 Aug 21;7(16):e009934. doi: 10.1161/JAHA.118.009934. No abstract available.
- Davoodi S, Karimi A, Ahmadi SH, Marzban M, Movahhedi N, Abbasi K, Omran AS, Shirzad M, Sheikhvatan M, Abbasi SH, Bina P. Early outcome of off-pump versus on-pump coronary revascularization. Pan Afr Med J. 2014 Apr 22;17:309. doi: 10.11604/pamj.2014.17.309.1723. eCollection 2014.
- Lewicki L, Siebert J, Rogowski J. Atrial fibrillation following off-pump versus on-pump coronary artery bypass grafting: Incidence and risk factors. Cardiol J. 2016;23(5):518-523. doi: 10.5603/CJ.a2016.0066. Epub 2016 Sep 26.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Arrhythmia in CABG
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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