Coronary Bypass Graft SurgeryNCT03871647
Effect of Genetic Polymorphism on the Occurrence of Post-Operative Atrial Fibrillation After CABG
An observational study of Coronary Bypass Graft Surgery and Atrial Fibrillation, run by Ain Shams University at 1 site in Egypt.
Trial summary
Postoperative Atrial Fibrillation (POAF) is one of the most common complications following coronary artery bypass grafting (CABG) occurring to 20% - 40% of patients. It is associated with prolonged hospitalization, increased hospital costs, increased complications and mortality rate. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronary Bypass Graft Surgery, Atrial Fibrillation
- What is being tested?
- Beta blocker
- How many people
- 256 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Mar 2019to 7 Mar 2021
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Egyptian patients undergoing Coronary Artery Bypass grafting Surgery
Who may be able to join
- Age above 18 years.
- Candidates for CABG surgery without a concurrent valve surgery.
- Patients receiving perioperative beta blockers before new onset of postoperative AF.
Who cannot join
- Patients who have either persistent or permanent AF, atrial flutter or atrial tachycardia on ECG obtained on the day of the operation.
- Serum creatinine >2 mg/dL before the surgery.
- Uncontrolled thyroid disease.
- Recent treatment with amiodarone before the occurrence of POAF
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Genetic Polymorphism on the Occurrence of Post-Operative Atrial Fibrillation After Coronory Artery Bypass Grafting (CABG) Surgery in Egyptian Patients Receiving Beta Blockers
Postoperative Atrial Fibrillation (POAF) is one of the most common complications following coronary artery bypass grafting (CABG) occurring to 20% - 40% of patients. It is associated with prolonged hospitalization, increased hospital costs, increased complications and mortality rate.
Despite the use of Beta Blockers, approximately 20% of patients develop atrial fibrillation following CABG surgery, suggesting a role for polymorphism in the genes The aim of the present study is to determine the minor allele frequency of some of the genes that affect the beta blockers' response and to determine the association between polymorphism in these genes and the occurrence of postoperative atrial fibrillation after coronary artery bypass grafting in Egyptian patients receiving perioperative beta blockers.
- Conditions
- Coronary Bypass Graft Surgery, Atrial Fibrillation
- Being tested
- Beta blocker
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta blockerDrug
perioperative beta blockers
| Study group | Role | What they receive |
|---|---|---|
| POAF group | Patients who will experience AF at any time during the first six days after the operation. Receives: Drug: Beta blocker | |
| Non POAF group | Patients with a sinus rhythm during the first six days after the operation. Receives: Drug: Beta blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Atrial fibrillation
Atrial fibrillation based on postoperative electrocardiogram. AF diagnostic criteria will include absence of discrete P waves, the RR intervals follow unrepetitive form and the ranges of ventricular rate usually between 90 and 170 beats/min.
Measured: within 6 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start11 Mar 2019
- Primary completion7 Dec 2020
- Study completion7 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Bypass Graft SurgeryStudies 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
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Misr International University
- Responsible party
- Principal investigator, Dina Mohamed Kamal El gindy, Misr International University
- Investigators
- Dina M El Gindy, MSC, Principal investigator, Misr Ineternational UniversityLamiaa M ElWakeel, PhD, Study chair, Ain Shams UniversityMona F Schaalan, PhD, Study director, Misr International UniversityRamy MR Khorshid, Md, PhD, Study director, Ain Shams UiversityMohamed H Solayman, PhD, Study director, Ain Sham University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871647
- Sponsor's protocol ID
- PhD 53
- Status last verified
- Nov 2021
- First submitted
- 11 Mar 2019
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
El Gindy DMK, Solayman MH, Khorshid R, Schaalan MF, El Wakeel LM. Effect of Clinical and Genetic Factors on the Development of Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting (CABG) in Egyptian Patients Receiving Beta-Blockers. Cardiovasc Drugs Ther. 2024 Feb;38(1):99-108. doi: 10.1007/s10557-022-07380-6. Epub 2022 Sep 15.
PubMed 36107363
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Genetic Polymorphism on the Occurrence of Post-Operative Atrial Fibrillation After Coronory Artery Bypass Grafting (CABG) Surgery in Egyptian Patients Receiving Beta Blockers
- ClinicalTrials.gov ID
- NCT03871647
- Acronym / sponsor ID
- PhD 53
- Conditions
- Coronary Bypass Graft Surgery, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Misr International University
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Mar 2021 (actual)
- First posted
- 12 Mar 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.
Postoperative Atrial Fibrillation (POAF) is one of the most common complications following coronary artery bypass grafting (CABG) occurring to 20% - 40% of patients. It is associated with prolonged hospitalization, increased hospital costs, increased complications and mortality rate.
Despite the use of Beta Blockers, approximately 20% of patients develop atrial fibrillation following CABG surgery, suggesting a role for polymorphism in the genes The aim of the present study is to determine the minor allele frequency of some of the genes that affect the beta blockers' response and to determine the association between polymorphism in these genes and the occurrence of postoperative atrial fibrillation after coronary artery bypass grafting in Egyptian patients receiving perioperative beta blockers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POAF group | – | Drug: Beta blockerPatients who will experience AF at any time during the first six days after the operation. |
| Non POAF group | – | Drug: Beta blockerPatients with a sinus rhythm during the first six days after the operation. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Egyptian patients undergoing Coronary Artery Bypass grafting Surgery
Key inclusion criteria (3 listed)
- Age above 18 years.
- Candidates for CABG surgery without a concurrent valve surgery.
- Patients receiving perioperative beta blockers before new onset of postoperative AF.
Key exclusion criteria (4 listed)
- Patients who have either persistent or permanent AF, atrial flutter or atrial tachycardia on ECG obtained on the day of the operation.
- Serum creatinine >2 mg/dL before the surgery.
- Uncontrolled thyroid disease.
- Recent treatment with amiodarone before the occurrence of POAF
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 |
|---|---|---|
| Beta blockerperioperative beta blockers | Drug | Non POAF group, POAF group |
Primary outcome
Occurrence of Atrial fibrillation
Time frame: within 6 days after the operation
Atrial fibrillation based on postoperative electrocardiogram. AF diagnostic criteria will include absence of discrete P waves, the RR intervals follow unrepetitive form and the ranges of ventricular rate usually between 90 and 170 beats/min.
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 9 Nov 2021.
- Derived from this study: PubMed 36107363El Gindy DMK, Solayman MH, Khorshid R, Schaalan MF, El Wakeel LM. Effect of Clinical and Genetic Factors on the Development of Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting (CABG) in Egyptian Patients Receiving Beta-Blockers. Cardiovasc Drugs Ther. 2024 Feb;38(1):99-108. doi: 10.1007/s10557-022-07380-6. Epub 2022 Sep 15.
- Individual participant dataSharing planned: Undecided
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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.
Dina M El Gindy, MSC principal investigator
Misr Ineternational University
Lamiaa M ElWakeel, PhD study chair
Ain Shams University
Mona F Schaalan, PhD study director
Misr International University
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 Coronary Bypass Graft Surgery and 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 4 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 9 Nov 2021. 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?
Occurrence of Atrial fibrillation (time frame: within 6 days after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03871647, which also lists 1 linked publication.
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 9 Nov 2021.