Clinical trial NCT04093817: Arrhythmia in on Pump vs. Off Pump Coronary Artery Bypass Grafting
Official title: Arrhythmia in on Pump vs. Off Pump Coronary Artery Bypass Grafting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Heart Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-18
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients under going coronary artery bypass grafting from ischemic heart disease

Brief summary: The aim of this research is to know the incidence of arrhythmias in on vs. off pump CABG and to know their relations to the patient's morbidity and mortality, hospital stay and hospital costs.

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There is a criticism regarding completence of revascularization in off pump vs. on pump CABG, this is no longer valid in the current era as technology to safely perform multi vessel off pump has improved tremendously over the past decade.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.

Eligibility criteria: Inclusion Criteria:

* All patients subjected to CABG

Exclusion Criteria:

* Associated valvular heart disease
* Emergency cases
* Previous AF

Primary outcomes:
measure: the incidence of arrhythmias in on pump vs. off pump coronary artery bypass grafting
timeFrame: the number of episodes of arrhythmia s in one week after the operation
Secondary outcomes:
measure: decrease morbidity, mortality, hospital stay and hospital cost
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Samy Othman, prof.dr
role: STUDY_CHAIR
affiliation: Assiut University
name: Ahmed Taha, lecturer
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.