Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-06 @ 9:58 AM
Study NCT ID:
NCT04993456
Status:
UNKNOWN
Last Update Posted:
2021-08-17
First Post:
2021-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Calcitonin Level and New-onset of Post-Operative Atrial Fibrillation
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': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2024-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-14', 'studyFirstSubmitDate': '2021-06-24', 'studyFirstSubmitQcDate': '2021-07-28', 'lastUpdatePostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Thromboembolic stroke', 'timeFrame': '2 years after cardiac surgery', 'description': 'Thromboembolic stroke'}, {'measure': 'Serious bleeding events', 'timeFrame': '2 years after cardiac surgery', 'description': 'Serious bleeding events'}, {'measure': 'All-cause mortality', 'timeFrame': '2 years after cardiac surgery', 'description': 'Cardiovascular, noncardiovascular or undetermined cause of death'}, {'measure': 'Recurrence atrial fibrillaiton and readmission', 'timeFrame': '2 years after cardiac surgery', 'description': 'Recurrence atrial fibrillaiton and readmission'}], 'primaryOutcomes': [{'measure': 'POAF lasting longer than 30 seconds during the first week after cardiac surgery', 'timeFrame': '2 years after cardiac surgery', 'description': 'The incidence of atrial fibrillation lasting longer than 30 seconds during the first week after cardiac surgery'}], 'secondaryOutcomes': [{'measure': 'The hospitalization days', 'timeFrame': '2 years after cardiac surgery', 'description': 'The length of stay after the cardiac surgery'}, {'measure': 'Ventricular rate of the atrial fibrillation', 'timeFrame': '2 years after cardiac surgery', 'description': 'Ventricular rate of atrial fibrillation after the cardiac surgery'}, {'measure': 'Levels of serum calcitonin', 'timeFrame': '2 years after cardiac surgery', 'description': 'Levels of serum calcitonin of atrial fibrillation after the cardiac surgery'}, {'measure': 'Levels of serum procalcitonin', 'timeFrame': '2 years after cardiac surgery', 'description': 'Levels of serum procalcitonin of atrial fibrillation after the cardiac surgery'}, {'measure': 'Levels of serum hsCRP', 'timeFrame': '2 years after cardiac surgery', 'description': 'Levels of serum hsCRP of atrial fibrillation after the cardiac surgery'}, {'measure': 'Levels of serum cytokines(IL-1β，IL-2R，IL-6，IL-8，IL-10，TNF-α)', 'timeFrame': '2 years after cardiac surgery', 'description': 'Levels of serum cytokines(IL-1β，IL-2R，IL-6，IL-8，IL-10，TNF-α) of atrial fibrillation after the cardiac surgery'}, {'measure': 'Atrial fibrillation burden after cardiac surgery', 'timeFrame': 'lidan2014@tjh.tjmu.edu.cn', 'description': 'Time and length of atrial fibrillation after cardiac surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-operative atrial fibrillation', 'Calcitonin', 'Cardiac surgery'], 'conditions': ['Calcitonin Secretion Disorder', 'Post-operative Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Post-operative atrial fibrillation (POAF) is one of the common complicaiton following cardiac surgery, occurring in approximately 20%-40% patients. Although POAF is associated with longer hospital stays, most POAF is short lived and resolves in the 2-4 days afer cardiac surgery.\n\nHowever, a recent meta-analysis showed significant increases in 1,5, and 10 year mortality in POAF patients (odds ratio:1.60, 2.60, 1.51;95% confidence intervals: 1.52 to 1.68, 2.00 to 3.38, 1.43 to 1.60;P \\<0.0001), the combined adjusted risk of death (16 studies, n =84,295) was also significantly increased in patients with POAF (hazard ratio: 1.25;95% confidence interval: 1.2-1.3;P \\< 0.0001).\n\nThese data highlight the need to understand better the underlying mechanism of POAF. A latest research in Nature reported levels of circulating calcitonin (CT), which is the main risk factor for atrial fibrillation (AF). Global disruption of CT receptor signalling in mice causes atrial fibrosis and increases susceptibility to AF.\n\nHere we will explore the relationship between CT and POAF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'It is expected that 200 patients who received the first non-emergency cardiopulmonary bypass cardiac surgery in our hospital will be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\. Clinical diagnosis of no history of atrial fibrillation/flutter;\n* 2\\. Heart rate ≥50 beats/min;\n* 3\\. EF \\> 40%;\n* 4\\. No history of emergency cardiac surgery in our hospital;\n* 5\\. Participate voluntarily and sign the informed consent, and can accept the follow-up of more than 2 years.\n\nExclusion Criteria:\n\n* 1\\. Atrial fibrillation/flutter;\n* 2\\. Left atrial diameter \\>5.5cm;\n* 3\\. Previous cardiac surgery or emergency surgery (\\<12h);\n* 4\\. Sick sinus node syndrome;\n* 5\\. Ventricular preexcitation or preexcitation syndrome;\n* 6\\. Second degree or above atrioventricular block;\n* 7.Myocardial infarction occurred within 7 days;\n* 8\\. Infection, sepsis, rheumatic or inflammatory diseases;\n* 9\\. Abnormal liver and kidney function (three times higher than the upper limit of normal);\n* 10\\. Uncontrolled hyperthyroidism, severe obstructive sleep apnea, and acute alcoholism;\n* 11\\. Any ischemic events (stroke or TIA) that occurred 180 days before the participant signed the informed consent, or any known unresolved complications from previous stroke/TIA;Thrombosis;\n* 12\\. Patients with other diseases requiring radiotherapy, chemotherapy and long-term hormone therapy;\n* 13\\. Patients' life expectancy makes it unlikely that follow-up will be completed;\n* 14\\. Participate in, or are expected to participate in, other clinical trials of any drugs, devices or biologics during the study period;\n* 15\\. Patients with contraindications to dynamic electrocardiogram;\n* 16\\. Patients who are unwilling or unable to fully comply with study procedures and follow-up."}, 'identificationModule': {'nctId': 'NCT04993456', 'briefTitle': 'Calcitonin Level and New-onset of Post-Operative Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Division of Cardiology, Department of Internal Medicne, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China', 'orgStudyIdInfo': {'id': 'TJ-CT-POAF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'POAF group', 'description': 'the patients will have atrial fibrillation following the cardiac surgery', 'interventionNames': ['Procedure: Caridac surgery']}, {'label': 'non-POAF group', 'description': 'the patients will have no atrial fibrillation following the cardiac surgery', 'interventionNames': ['Procedure: Caridac surgery']}], 'interventions': [{'name': 'Caridac surgery', 'type': 'PROCEDURE', 'description': 'Cardiac surgery', 'armGroupLabels': ['POAF group', 'non-POAF group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Ni, PHD', 'role': 'CONTACT', 'email': 'nili@tjh.tjmu.edu.cn', 'phone': '+862783662479'}], 'facility': 'Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Division of Cardiology, Department of Internal Medicne', 'investigatorFullName': 'Li Ni', 'investigatorAffiliation': 'Tongji Hospital'}}}}