Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT06763120
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-08
First Post:
2024-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post Operative Atrial Fibrillation Post Cardiac Surgery ( CABG and VALVE REPLACEMENT )
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-01', 'studyFirstSubmitDate': '2024-12-15', 'studyFirstSubmitQcDate': '2025-01-01', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative atrial fibrillation', 'timeFrame': 'One year', 'description': 'Prevelance of post operative atrial fibrillation in patients undergoing cardiac surgery ( past CABG and valve replacement )'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post operative atrial fibrillation', 'Cardiac surgery'], 'conditions': ['Post Operative Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '25087786', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '14998610', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15082699', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26386789', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the percent and risk factors of postoperative atrial fibrillation in patients undergoing cardiac surgery in Assiut university heart hospital', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. ≥18 years scheduled for first-time planned cardiac surgery ( CABG and Valve replacement)\n2. Patients who are in sinus rhythm and not taking any antiarrhythmic medication, other than beta-adrenergic blocking agents, at the time of surgery.\n3. Willingness to participate and provision of informed consent', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥18 years scheduled for first-time planned cardiac surgery ( CABG and Valve replacement)\n2. Patients who are in sinus rhythm and not taking any antiarrhythmic medication, other than beta-adrenergic blocking agents, at the time of surgery.\n3. Willingness to participate and provision of informed consent\n\nExclusion Criteria:\n\n1. Prior history of cardiac surgery.\n2. Pediatric population less than 18 years.\n3. Patients with history of hyperthyroidism\n4. Patients with electrolyte disturbance\n5. Where follow-up is not possible.\n6. The patient refused to sign the informed consent to participate in the research.'}, 'identificationModule': {'nctId': 'NCT06763120', 'briefTitle': 'Post Operative Atrial Fibrillation Post Cardiac Surgery ( CABG and VALVE REPLACEMENT )', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Prevelance and Risk Predictors of Post-operative Atrial Fibrillation Among Patients Undergoing Cardiac Surgery At Assiut University Heart Hospital', 'orgStudyIdInfo': {'id': 'Post operative AF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'First group is patients who developed post operative atrial fibrillation', 'description': 'Patients who developed post operative atrial fibrillation post CABG or valve replacement'}, {'label': "Second group is patients who don't develop post operative atrial fibrillation", 'description': "Patient who don't develop post operative atrial fibrillation post CABG or valve replacement"}]}, 'contactsLocationsModule': {'locations': [{'zip': '2063045', 'city': 'Asyut', 'state': 'Egypt', 'country': 'Egypt', 'facility': 'Faculty of medicine Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Bahaa Al Moris, Master', 'role': 'CONTACT', 'email': 'bahaa01225753582@gmail.com', 'phone': '+2001225753582'}, {'name': 'Beshoy Al Moris, Master', 'role': 'CONTACT', 'email': 'bahaa01225753582@gmail.com', 'phone': '+201288476139'}], 'overallOfficials': [{'name': 'Amr Ah Youssef, M,D', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut university heart hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor', 'investigatorFullName': 'Bahaa Allaam Moris Hakeem', 'investigatorAffiliation': 'Assiut University'}}}}