Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT00188903
Status:
COMPLETED
Last Update Posted:
2010-08-05
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diastolic Dysfunction and Atrial Fibrillation in CABG Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-03', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2010-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Is to determine if patients with preoperative diastolic dysfunction are exposed to higher risk of AF after coronary revascularization surgery.', 'timeFrame': 'pre and post operative'}], 'secondaryOutcomes': [{'measure': 'Is to determine if diastolic dysfunction and AF are associated with increased perioperative cardiac morbidity and reduced event-free survival.', 'timeFrame': 'post operative until discharge'}]}, 'conditionsModule': {'keywords': ['Cardiac Surgery', 'Diastolic Dysfunction', 'Atrial Fibrillation'], 'conditions': ['Heart Disease', 'Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '25005721', 'type': 'DERIVED', 'citation': 'Ashes CM, Yu M, Meineri M, Katznelson R, Carroll J, Rao V, Djaiani G. Diastolic dysfunction, cardiopulmonary bypass, and atrial fibrillation after coronary artery bypass graft surgery. Br J Anaesth. 2014 Nov;113(5):815-21. doi: 10.1093/bja/aeu208. Epub 2014 Jul 8.'}]}, 'descriptionModule': {'briefSummary': 'Left ventricular (LV) diastolic dysfunction is a common manifestation of heart disease that is responsible for significant morbidity and mortality.It is present when the ventricular filling is impaired as a result of delayed relaxation or decreased compliance. During Coronary artery bypass grafting (CABG) surgery, LV diastolic dysfunction is a frequent occurrence. Failure of the left ventricle to dilate normally causes an increase in LV filling pressure. Atrial fibrillation (AF) is a common complication after cardiac surgery affecting 20-30% of patients undergoing coronary revascularization procedures. AF is associated with significant morbidity and mortality and has been identified as a causative factor of increased length of both hospital and intensive care unit (ICU) stay after CABG surgery, resulting in increased resource utilization and medical care costs.The primary aim of this study is to determine if patients with preoperative diastolic dysfunction are exposed to higher risk of AF after coronary revascularization surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Elective coronary artery bypass graft patients either on or off pump in acute care centre', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scheduled for elective CABG or OPCAB surgery\n* signed informed consent\n\nExclusion Criteria:\n\n* Patients with a history of previous heart surgery and/or undergoing valvular heart surgery.\n* Patients with preoperative atrial fibrillation.\n* Patients in whom TEE is contraindicated.'}, 'identificationModule': {'nctId': 'NCT00188903', 'briefTitle': 'Diastolic Dysfunction and Atrial Fibrillation in CABG Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Diastolic Dysfunction and Atrial Fibrillation in Patients Undergoing Coronary Revascularization Surgery', 'orgStudyIdInfo': {'id': 'UHN REB 03-0873-A'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Diastolic measurements during TEE', 'type': 'PROCEDURE', 'description': 'Transesophageal echocardiography with diastolic measurements'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'George N Djaiani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toronto General Hospital, Univsersity Health Network'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'George Djaiani', 'oldOrganization': 'Toronto General Hospital, University Health Network'}}}}