Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-03 @ 2:57 PM
Study NCT ID:
NCT02547194
Status:
COMPLETED
Last Update Posted:
2016-03-31
First Post:
2015-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Graft Patency as a Predictor of Health-related Quality of Life.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 254}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-29', 'studyFirstSubmitDate': '2015-09-09', 'studyFirstSubmitQcDate': '2015-09-10', 'lastUpdatePostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The health-related quality of life.', 'timeFrame': '5-15 years postoperatively.', 'description': 'EQ-5D is a generic measure of health. The instrument can be used to measure quality of life change in a population over time and to compare the quality of life among different groups in the population such as different socio-economic groups. EQ-5D is constructed of five dimensions: mobility, care, usual activities, pain / discomfort and anxiety / depression. Each dimension is answered on a three-point scale (none, moderate or severe symptoms). With this instrument, it can theoretically be 243 possible health conditions. Health condition can also be described as an index value between 0 corresponding to death and one equivalent full health. Some negative values corresponding a state worse than death can occur. Moreover consists EQ-5D of a VAS scale (Visual Analogue Scale), a thermometer-like scale, with 0 being the worst possible health status and 100 representing full health.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['coronary artery bypass grafting', 'saphenous vein', 'no-touch technique'], 'conditions': ['Ischemic Heart Disease', 'Atherosclerosis']}, 'referencesModule': {'references': [{'pmid': '28040753', 'type': 'DERIVED', 'citation': 'Samano N, Bodin L, Karlsson J, Geijer H, Arbeus M, Souza D. Graft patency is associated with higher health-related quality of life after coronary artery bypass surgery. Interact Cardiovasc Thorac Surg. 2017 Mar 1;24(3):388-394. doi: 10.1093/icvts/ivw372.'}]}, 'descriptionModule': {'briefSummary': 'The health-related quality of life questionnaire "EQ-5D" has been collected in connection with several interventional and observational studies where the no-touch vein harvesting technique in CABG has been used. The results of the questionnaires will be compiled and reported in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients included in the study have been operated on at the department of Cardiothoracic and Vascular Surgery, Orebro University Hospital, Orebro, Sweden.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Operated at our department for a coronary artery bypass surgery with either the no-touch harvesting technique of conventional harvesting technique.\n2. Completed the EQ-5D questionnaire.\n3. Signed and dated consent.\n\nExclusion Criteria:\n\n1. Substantial missing data from the EQ-5D questionnaire.\n2. Unable to comprehend the different inquiries in the questionnaire.'}, 'identificationModule': {'nctId': 'NCT02547194', 'briefTitle': 'Graft Patency as a Predictor of Health-related Quality of Life.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Örebro County Council'}, 'officialTitle': 'Graft Patency as a Predictor of Health-related Quality of Life in Coronary Artery Bypass Patients.', 'orgStudyIdInfo': {'id': '167861'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No touch vein grafts', 'description': 'The grafts were harvested with there surrounding tissues.'}, {'label': 'Conventional vein grafts.', 'description': 'The grafts were stripped from surrounding tissue.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70185', 'city': 'Örebro', 'country': 'Sweden', 'facility': 'Department for Cardiothoracic and Vascular Surgery, Örebro University Hospital', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}], 'overallOfficials': [{'name': 'Ninos Samano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Örebro University, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Örebro County Council', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiothoracic Surgeon', 'investigatorFullName': 'Ninos Samano M.D.', 'investigatorAffiliation': 'Örebro University, Sweden'}}}}