Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
Study NCT ID:
NCT06855550
Status:
COMPLETED
Last Update Posted:
2025-03-07
First Post:
2025-02-24
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postoperative Incidence of Atrial Fibrillation Following Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 435}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2025-02-24', 'studyFirstSubmitQcDate': '2025-02-27', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Atrial fibrilation', 'timeFrame': 'Measurement was performed first day after surgery up to 30 days postoperatively or discharge (whichever came first)', 'description': 'Defined as irregular QRS without p wave during 30 seconds in a 12 derivations EKG.'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Measurement was performed first day after surgery up to 30 days postoperatively or discharge (whichever came first)', 'description': 'Overall mortality rate.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation (AF)', 'Hypomagnesemia', 'Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'Introduction: Postoperative atrial fibrillation is one of the most frequent complications in cardiac surgery, with an expected incidence of more than 50% following valve surgery. Hypomagnesemia is also likely to be observed in the postoperative period, and several studies have suggested that it could be related to the incidence of postoperative atrial fibrillation. In this study, via a prospective design and adjustment for multiple covariates, the investigators will seek to determine whether plasma magnesium levels are independently associated with the appearance of postoperative atrial fibrillation.\n\nMethods: An analytical design involving a concurrent cohort will be carried out in a high-complexity hospital with a cardiovascular focus. Serial postoperative plasma magnesium measurements will be included as independent variables in a logistic regression model to determine their association with atrial fibrillation after adjusting for multiple covariates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent cardiac surgery at Fundación Cardioinfantil-Instituto de Cardiología, from May 2015 to May 2016.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults in postoperative cardiac surgery\n\nExclusion Criteria:\n\n* Preoperative atrial fibrillation\n* Without complete information regarding plasmatic magnesium postoperative measurements'}, 'identificationModule': {'nctId': 'NCT06855550', 'briefTitle': 'Postoperative Incidence of Atrial Fibrillation Following Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Cardioinfantil Instituto de Cardiología'}, 'officialTitle': 'Evaluation of Plasmatic Magnesium Levels and Its Association with Atrial Fibrillation After Cardiac Surgery', 'orgStudyIdInfo': {'id': '2023PROCCA0043'}, 'secondaryIdInfos': [{'id': '2023PROCCA0043', 'type': 'OTHER', 'domain': 'Fundación Cardioinfantil-Instituto de Cardiología'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Postoperative cardiac surgery', 'description': 'Patients who will undergo elective cardiac surgery of any kind will be included, except those with a history of preoperative atrial fibrillation, urgent/emergency surgery, or those who will undergo maze surgery (alone or in combination with other procedures).\n\nMagnesium levels will be measured immediately after surgery and every subsequent 12-24 hours during the stay in the intensive care unit. Each patient will be followed up, and morbidity and mortality will be recorded through in-hospital evaluation or up to 30 days postoperatively (whichever occurs first). Follow-up will be performed by a member of the research team who will be blinded to the postoperative magnesium levels. Preoperative evaluation, premedication, anesthetic/surgical technique, and postoperative care will conducted according to institutional protocols; no modifications of any kind will be made for the participants.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110131', 'city': 'Bogotá', 'state': 'Bogota D.C.', 'country': 'Colombia', 'facility': 'Fundación Cardioinfantil-Instituto de Cardiología', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data from the study would be provided by request to the principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Cardioinfantil Instituto de Cardiología', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Cardiovascular Critical Care', 'investigatorFullName': 'Edgar Hernández Leiva', 'investigatorAffiliation': 'Fundación Cardioinfantil Instituto de Cardiología'}}}}