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AF - Atrial FibrillationNCT04193813

Predictors of Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting: A Prospective Cohort Study

An observational study of AF - Atrial Fibrillation, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There are a wide range of significant epidemiological, clinical, and operative predictors for the development of post-CABG AF including older age, female gender, large LA diameter, higher CHA2DS2-VASc score, valve replacement and postoperative inotropic support. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
AF - Atrial Fibrillation
What is being tested?
Observational
How many people
123 participants
Where
1 siteEgypt
Study dates
15 May 2018to 23 May 2019
How long will I take part?
3 Days
Phase
Observational
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing isolated CABG or CABG with (Aortic and / or Mitral) valve replacement with an age group between 18 and 70 years old.

Who may be able to join

  • Patients undergoing isolated CABG
  • Patients undergoing CABG with (Aortic and / or Mitral) valve replacement
  • age group between 18 and 70 years old.

Who cannot join

  • Patients diagnosed preoperatively with AF or have history of AF
  • Patients with history of existing pre-operative rhythm other than normal sinus rhythm (NSR)
  • Patients with impaired systolic function (Ejection fraction (EF) < 30%)
  • Patients with end stage renal disease (ESRD) on hemodialysis
  • Patients who refused to participate in the study

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Hanaa El Gendy

    Cairo, Ain Shams University Specialized Hospital

Other trials in Egypt

About this study

There are a wide range of significant epidemiological, clinical, and operative predictors for the development of post-CABG AF including older age, female gender, large LA diameter, higher CHA2DS2-VASc score, valve replacement and postoperative inotropic support. Nevertheless, further large-scale studies are still needed to confirm our findings

Read the detailed description

We included patients undergoing isolated CABG or CABG with (Aortic and / or Mitral) valve replacement with an age group between 18 and 70 years old.

Patients diagnosed preoperatively with AF or have history of AF, patients with history of existing pre-operative rhythm other than normal sinus rhythm (NSR), patients with impaired systolic function (Ejection fraction (EF) < 30%), patients with end stage renal disease (ESRD) on hemodialysis and patients who refused to participate in the study were excluded from the study.

Sample Size and Sampling: Using PASS program, setting alpha error at 5% and power 80%. Results from previous study Ducceschi et al. (6) showed that left atrial (LA) diameter was an independent factor affecting AF post CABG. Based on this, the needed sample was 123 cases undergoing CABG, including at least 24 patients with dilated LA.

All individuals were monitored for AF during the postoperative ICU stay with continuous ECG (5-leads) monitor, daily 12-lead ECG recording to confirm an episode of AF. AF was considered if P wave was absent before the QRS complex together with irregular ventricular rhythm on the rhythm strips.

Only AF episodes lasting > 5 minutes were counted. In the present study, the following data, as potential predictors of POAF, was collected from every eligible participant; age, sex, smoking and left atrial (LA) diameter based on formal preoperative Trans-thoracic Echocardiography. Serum potassium (K+) level was routinely measured postoperatively on ICU admission and every 2 hours and on demand (if arrhythmia occurs or suspected abnormal potassium level). It was recorded for statistical analysis on admission and every 12 hours and on demand until the patient was discharged.

Serum Magnesium (Mg++) level was measured routinely measured postoperatively on ICU admission and every 24 hours and on demand (if arrhythmia occurs or suspected abnormal magnesium level). It was recorded for statistical study on admission and every 24 hours and on demand until the patient was discharged.

Other parameters such as valve replacement (Aortic and/or Mitral) during the same operative setting, CHA2DS2-VASc score (Congestive heart failure, Hypertension [blood pressure >140/90 mm Hg or treated hypertension on medication], Age ≥75 years, Diabetes mellitus, prior Stroke or transient ischemic attack or thromboembolism, vascular disease, Age 65 to 74 years, Sex category [female sex] ), and post-operative inotropic support usage were recorded.

Being tested
Observational
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObservationalOther

    Observational study

Study groups in NCT04193813
Study groupRoleWhat they receive
POAFNot described
Receives: Other: Observational
Non POAFNot described
Receives: Other: Observational

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of POAF

    Incidence of POAF 72hours postoperative

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2019
  2. Study start15 May 2018
  3. Primary completion18 Mar 2019
  4. Study completion23 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
123 participants (actual)
Target duration
3 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT04193813
Sponsor's protocol ID
El-Manial Hospital
Status last verified
May 2020
First submitted
7 Dec 2019
Last updated
27 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of AF - Atrial Fibrillation, run by Ain Shams 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 27 May 2020. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of POAF (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 27 May 2020.

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