- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06763120
Post Operative Atrial Fibrillation Post Cardiac Surgery ( CABG and VALVE REPLACEMENT )
January 1, 2025 updated by: Bahaa Allaam Moris Hakeem, Assiut University
Prevelance and Risk Predictors of Post-operative Atrial Fibrillation Among Patients Undergoing Cardiac Surgery At Assiut University Heart Hospital
This study aims to assess the percent and risk factors of postoperative atrial fibrillation in patients undergoing cardiac surgery in Assiut university heart hospital
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Arrhythmias are common complications after cardiac surgery, with postoperative atrial fibrillation (POAF) being the most frequently observed arrhythmia.
The incidence rate of POAF ranges from 20% to 50%, depending on factors such as the type of surgery, patient population, and criteria used for diagnosis.
Notably, POAF has been associated with increased morbidity, mortality, and health care costs.
Patients who develop POAF are at a higher risk of experiencing complications such as stroke, heart failure (HF), and prolonged hospital stays.
Moreover, POAF has been linked to long-term adverse outcomes, including a greater risk of recurrence of AF/atrial flutter and increased mortality.
The accurate prediction of POAF can help guide therapy and facilitate targeted interventions to prevent its occurrence.
Early identification of patients at risk for POAF allows for the timely initiation of prophylactic measures, such as the use of β-blockers, amiodarone, or other antiarrhythmic drugs, which have been shown to reduce the incidence of POAF.
In this study we are searching for the percent and risk factors of POAF in patients undergoing cardiac surgery in Assiut university hospital.
Study Type
Observational
Enrollment (Estimated)
112
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bahaa Al Moris, Master
- Phone Number: +2001225753582
- Email: bahaa01225753582@gmail.com
Study Contact Backup
- Name: Beshoy Al Moris, Master
- Phone Number: +201288476139
- Email: bahaa01225753582@gmail.com
Study Locations
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Assiut, Egypt, 2063045
- Faculty of Medicine Assiut University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
- ≥18 years scheduled for first-time planned cardiac surgery ( CABG and Valve replacement)
- Patients who are in sinus rhythm and not taking any antiarrhythmic medication, other than beta-adrenergic blocking agents, at the time of surgery.
- Willingness to participate and provision of informed consent
Description
Inclusion Criteria:
- ≥18 years scheduled for first-time planned cardiac surgery ( CABG and Valve replacement)
- Patients who are in sinus rhythm and not taking any antiarrhythmic medication, other than beta-adrenergic blocking agents, at the time of surgery.
- Willingness to participate and provision of informed consent
Exclusion Criteria:
- Prior history of cardiac surgery.
- Pediatric population less than 18 years.
- Patients with history of hyperthyroidism
- Patients with electrolyte disturbance
- Where follow-up is not possible.
- The patient refused to sign the informed consent to participate in the research.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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First group is patients who developed post operative atrial fibrillation
Patients who developed post operative atrial fibrillation post CABG or valve replacement
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Second group is patients who don't develop post operative atrial fibrillation
Patient who don't develop post operative atrial fibrillation post CABG or valve replacement
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Post operative atrial fibrillation
Time Frame: One year
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Prevelance of post operative atrial fibrillation in patients undergoing cardiac surgery ( past CABG and valve replacement )
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One year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Amr Ah Youssef, M,D, Assiut University Heart Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Villareal RP, Hariharan R, Liu BC, Kar B, Lee VV, Elayda M, Lopez JA, Rasekh A, Wilson JM, Massumi A. Postoperative atrial fibrillation and mortality after coronary artery bypass surgery. J Am Coll Cardiol. 2004 Mar 3;43(5):742-8. doi: 10.1016/j.jacc.2003.11.023.
- Mathew JP, Fontes ML, Tudor IC, Ramsay J, Duke P, Mazer CD, Barash PG, Hsu PH, Mangano DT; Investigators of the Ischemia Research and Education Foundation; Multicenter Study of Perioperative Ischemia Research Group. A multicenter risk index for atrial fibrillation after cardiac surgery. JAMA. 2004 Apr 14;291(14):1720-9. doi: 10.1001/jama.291.14.1720.
- LaPar DJ, Speir AM, Crosby IK, Fonner E Jr, Brown M, Rich JB, Quader M, Kern JA, Kron IL, Ailawadi G; Investigators for the Virginia Cardiac Surgery Quality Initiative. Postoperative atrial fibrillation significantly increases mortality, hospital readmission, and hospital costs. Ann Thorac Surg. 2014 Aug;98(2):527-33; discussion 533. doi: 10.1016/j.athoracsur.2014.03.039.
- Melduni RM, Schaff HV, Bailey KR, Cha SS, Ammash NM, Seward JB, Gersh BJ. Implications of new-onset atrial fibrillation after cardiac surgery on long-term prognosis: a community-based study. Am Heart J. 2015 Oct;170(4):659-68. doi: 10.1016/j.ahj.2015.06.015. Epub 2015 Jun 28.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2025
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
August 30, 2026
Study Registration Dates
First Submitted
December 15, 2024
First Submitted That Met QC Criteria
January 1, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 1, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Post operative AF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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