NCT04093817

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 18, 2019

Completed
1.5 years until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

September 6, 2019

Last Update Submit

September 16, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • decrease morbidity, mortality, hospital stay and hospital cost

    baseline

Study Arms (2)

on pump CABG

patients under going CABG with cardiopulmonary bypass machine

Device: cardio pulmonary bypass machine

off pump CABG

patients under going CABG without cardiopulmonary bypass machine

Interventions

cardio pulmonary bypass machine is a machine that work to compensate for the function of the heart and the lungs in the operation

on pump CABG

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients under going coronary artery bypass grafting from ischemic heart disease

You may qualify if:

  • All patients subjected to CABG

You may not qualify if:

  • Associated valvular heart disease
  • Emergency cases
  • Previous AF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 30369328BACKGROUND
  • 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.

    PMID: 25328605BACKGROUND
  • 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.

    PMID: 27665857BACKGROUND

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Samy Othman, prof.dr

    Assiut University

    STUDY CHAIR
  • Ahmed Taha, lecturer

    Assiut University

    STUDY CHAIR

Central Study Contacts

Mohamed Kamel, resident doctor

CONTACT

Ali Abdelwahaab, prof.dr

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at cardiothoracic surgery department at Assiut university hospital

Study Record Dates

First Submitted

September 6, 2019

First Posted

September 18, 2019

Study Start

April 1, 2021

Primary Completion

May 1, 2022

Study Completion

July 1, 2022

Last Updated

September 18, 2019

Record last verified: 2019-09