Post Operative Atrial FibrillationNCT06763120
Post Operative Atrial Fibrillation Post Cardiac Surgery ( CABG and VALVE REPLACEMENT )
An observational study of Post Operative Atrial Fibrillation, run by Assiut University at 1 site in Egypt.
Trial summary
This study aims to assess the percent and risk factors of postoperative atrial fibrillation in patients undergoing cardiac surgery in Assiut university heart hospital Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Operative Atrial Fibrillation
- How many people
- 112 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 30 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. ≥18 years scheduled for first-time planned cardiac surgery ( CABG and Valve replacement) 2. Patients who are in sinus rhythm and not taking any antiarrhythmic medication, other than beta-adrenergic blocking agents, at the time of surgery. 3. Willingness to participate and provision of informed consent
Who may be able to join
- ≥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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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.
- Conditions
- Post Operative Atrial Fibrillation
- Keywords
- Post operative atrial fibrillation, Cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| First group is patients who developed post operative atrial fibrillation | Patients who developed post operative atrial fibrillation post CABG or valve replacement | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative atrial fibrillation
Prevelance of post operative atrial fibrillation in patients undergoing cardiac surgery ( past CABG and valve replacement )
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Operative Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahaa Allaam Moris Hakeem, Assiut University
- Investigators
- Amr Ah Youssef, M,D, Study chair, Assiut university heart hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763120
- Sponsor's protocol ID
- Post operative AF
- Status last verified
- Jan 2025
- First submitted
- 15 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25087786Villareal 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.
PubMed 14998610Mathew 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.
PubMed 15082699Melduni 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.
PubMed 26386789
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevelance and Risk Predictors of Post-operative Atrial Fibrillation Among Patients Undergoing Cardiac Surgery At Assiut University Heart Hospital
- ClinicalTrials.gov ID
- NCT06763120
- Acronym / sponsor ID
- Post operative AF
- Conditions
- Post Operative Atrial Fibrillation
- Keywords
- Post operative atrial fibrillation, Cardiac surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 8 Jan 2025 (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.
This study aims to assess the percent and risk factors of postoperative atrial fibrillation in patients undergoing cardiac surgery in Assiut university heart hospital
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First group is patients who developed post operative atrial fibrillation | – | –Patients who developed post operative atrial fibrillation post CABG or valve replacement |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. ≥18 years scheduled for first-time planned cardiac surgery ( CABG and Valve replacement) 2. Patients who are in sinus rhythm and not taking any antiarrhythmic medication, other than beta-adrenergic blocking agents, at the time of surgery. 3. Willingness to participate and provision of informed consent
Key inclusion criteria (3 listed)
- ≥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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post operative atrial fibrillation
Time frame: One year
Prevelance of post operative atrial fibrillation in patients undergoing cardiac surgery ( past CABG and valve replacement )
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Background: PubMed 25087786LaPar 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.
- Background: PubMed 14998610Villareal 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.
- Background: PubMed 15082699Mathew 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.
- Background: PubMed 26386789Melduni 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.
- 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.
Amr Ah Youssef, M,D study chair
Assiut university heart hospital
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 Post Operative Atrial Fibrillation, run by Assiut 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 6 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: opening soon, as of the sponsor's last update on 8 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bahaa Al Moris, Master (+2001225753582, bahaa01225753582@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative atrial fibrillation (time frame: One year). 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 NCT06763120, which also lists 4 linked publications.
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 8 Jan 2025.