Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT00259194
Status:
COMPLETED
Last Update Posted:
2009-06-11
First Post:
2005-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observation and Prediction of Complications After Coronary Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-08', 'studyFirstSubmitDate': '2005-11-28', 'studyFirstSubmitQcDate': '2005-11-28', 'lastUpdatePostDateStruct': {'date': '2009-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of bleeding complications', 'timeFrame': '4 days'}, {'measure': 'Model to predict bleeding complications', 'timeFrame': '4 days'}, {'measure': 'Assess if lying still in bed the first 2 hours after angiography affect the incidence of bleeding complications', 'timeFrame': '4 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary angiography', 'Complications', 'Observation'], 'conditions': ['Coronary Arteriosclerosis', 'Myocardial Ischemia']}, 'referencesModule': {'references': [{'pmid': '19245381', 'type': 'RESULT', 'citation': 'May O, Schlosser H, Skytte L. A high blood pressure predicts bleeding complications and a longer hospital stay after elective coronary angiography using the femoral approach. J Interv Cardiol. 2009 Apr;22(2):175-8. doi: 10.1111/j.1540-8183.2009.00427.x. Epub 2009 Feb 24.'}, {'pmid': '18513345', 'type': 'RESULT', 'citation': 'May O, Schlosser H, Skytte L. A randomized trial assessing the influence of lying still or being allowed to move in the observation period following coronary angiography using the femoral approach. J Interv Cardiol. 2008 Aug;21(4):347-9. doi: 10.1111/j.1540-8183.2008.00359.x. Epub 2008 May 29.'}]}, 'descriptionModule': {'briefSummary': "Coronary angiography via the femoral artery is regarded as a safe procedure, but bleeding complications are often seen. To avoid/reduce bleeding complications digital compression is applied in the area of puncture during approximately 20 minutes and the patient is in the investigators' department observed in bed for 2 hours. The investigators apply pressure over the puncture site using a sand bag in the first hour. The patients are told not to move, to keep their legs and upper arms down and not to lift the head from the pillow in these 2 hours (standard observation). In the present study the patients are randomized between standard observation and an alternative observation, where the patients are allowed to lift their head, arms and legs during the 2 hours, otherwise as standard observation.\n\nThe study has three aims:\n\n1. To establish the incidence of bleeding complications:\n\n * Frequency of hematoma (\\> 5 cm)\n * Frequency of pseudoaneurysms\n * Frequency of bleeding demanding surgery\n * Frequency of bleeding demanding transfusion\n2. Establish a model to predict in wich patient to expect a bleeding complication.\n3. Assess if the alternative observation is associated with more bleeding complications compared to standard observation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Coronary angiography by the femoral access, where the arterial lumen is reached.\n2. Only attempted puncture at one side.\n3. Age \\>= 18 years.\n\nExclusion Criteria:\n\n1. Conditions that makes observation in the department impossible.\n2. Dementia or other reasons to expect lack of compliance.\n3. Previous participation in the project.\n4. Implanted vascular prothesis at puncture site.'}, 'identificationModule': {'nctId': 'NCT00259194', 'acronym': 'OPKAT', 'briefTitle': 'Observation and Prediction of Complications After Coronary Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Herning Hospital'}, 'officialTitle': 'Observation and Prediction of Complications After Coronary Angiography', 'orgStudyIdInfo': {'id': 'OPKAT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Alternative Observation', 'description': 'Moving in bed during observation after coronary angiography', 'interventionNames': ['Behavioral: Moving']}, {'type': 'EXPERIMENTAL', 'label': 'Standard Observation', 'description': 'No moving in bed during observation after coronary angiography', 'interventionNames': ['Behavioral: No Moving']}], 'interventions': [{'name': 'Moving', 'type': 'BEHAVIORAL', 'description': 'The patients are allowed to lift their head, arms and legs during the 2 hours.', 'armGroupLabels': ['Alternative Observation']}, {'name': 'No Moving', 'type': 'BEHAVIORAL', 'description': 'The patients are told not to move, to keep their legs and upper arms down and not to lift the head from the pillow in these 2 hours.', 'armGroupLabels': ['Standard Observation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7400', 'city': 'Herning', 'country': 'Denmark', 'facility': 'Coronary Angiography Laboratory', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}, {'zip': '7400', 'city': 'Herning', 'country': 'Denmark', 'facility': 'Dept. of Med., Sect. of Cardology, Herning Hospital', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}], 'overallOfficials': [{'name': 'Ole May, Dr.,Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Dept. of Med., Section of Cardiol., Herning Hospital, DK-7400 Herning'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herning Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Medical Research Fund of the County of Ringkøbing', 'class': 'UNKNOWN'}]}}}