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.
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.
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.
- Conditions
- AF - Atrial Fibrillation
- 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 group | Role | What they receive |
|---|---|---|
| POAF | Not described Receives: Other: Observational | |
| Non POAF | Not described Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted10 Dec 2019
- Study start15 May 2018
- Primary completion18 Mar 2019
- Study completion23 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AF - Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanaa Mohamed Abdallah ElGendy MD, Ain Shams University
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
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04193813
- Acronym / sponsor ID
- El-Manial Hospital
- Conditions
- AF - Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POAF | – | Other: Observational |
| Non POAF | – | Other: Observational |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Patients undergoing isolated CABG
- Patients undergoing CABG with (Aortic and / or Mitral) valve replacement
- age group between 18 and 70 years old.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalObservational study | Other | Non POAF, POAF |
Primary outcome
Incidence of POAF
Time frame: 6 months
Incidence of POAF 72hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.