Arrhythmia in on Pump vs. Off Pump Coronary Artery Bypass Grafting

Ischemic Heart Disease Clinical Trial

Official title:

Arrhythmia in on Pump vs. Off Pump Coronary Artery Bypass Grafting

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04093817
• Other study ID #: Arrhythmia in CABG
• Status: Not yet recruiting
• Start date: April 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: September 2019
• Source: Assiut University
• Contact: Mohamed Kamel, resident doctor
• Phone: 01149625752\01063067860
• Email: memad_505[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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There is a criticism regarding completence of revascularization in off pump vs. on pump CABG, this is no longer valid in the current era as technology to safely perform multi vessel off pump has improved tremendously over the past decade.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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 1, 2022
• Est. primary completion date: May 1, 2022
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• All patients subjected to CABG

Exclusion Criteria:

• Associated valvular heart disease

• Emergency cases

• Previous AF

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• cardio pulmonary 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of arrhythmias in on pump vs. off pump coronary artery bypass grafting	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	decrease morbidity, mortality, hospital stay and hospital cost	To know the relation of the arrythmias in the number of days that the patient stays after the operation.; To know the relation of the arrhythmias as a cause to the mortality of these patients.(number of patients die after the operation from the total deaths from these two operations).; To know the the relation of the arrhythmias in these two operations to their patients morbidity.	baseline