Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-24 @ 10:03 PM
Study NCT ID:
NCT03774004
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2018-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plaque Burden Pre- Myocardial Revascularisation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 252}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-18', 'studyFirstSubmitDate': '2018-12-11', 'studyFirstSubmitQcDate': '2018-12-11', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association of MACE rates with peripheral atherosclerotic volume', 'timeFrame': '5 years'}, {'measure': 'Association of morbidity with peripheral atherosclerotic volume', 'timeFrame': '5 years', 'description': 'Morbidity will be evaluated with quality of life assessment ("EQ-5D-3L", "IPAQ"'}], 'secondaryOutcomes': [{'measure': 'Comparison of predictive value of peripheral atherosclerotic volume with established risk scores for cardiovascular operations and interventions', 'timeFrame': '1 year', 'description': 'Risk scores include STS Score and Euro Score'}, {'measure': 'Association of the duration of the operation with peripheral atherosclerotic volume', 'timeFrame': '30 days'}, {'measure': 'Association of flow profiles of internal mammary artery with LIMA/RIMA graft patency rates', 'timeFrame': '5 years'}, {'measure': 'Association of the aortic clamp time with peripheral atherosclerotic volume', 'timeFrame': '30 days'}, {'measure': 'Association of the ICU stay with peripheral atherosclerotic volume', 'timeFrame': '30 days'}, {'measure': 'Association of the hospitalization duration with peripheral atherosclerotic volume', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'The study is a prospective-observational, explorative single-centre cohort study aimed to examine the influence of the peripheral atherosclerotic plaque volume on short and long term morbidity and mortality in patient after coronary artery bypass grafting (CABG).\n\nAtherosclerotic disease (IMT, plaque volume) will be measured with a ultrasound system (IMT measurements and 3D quantitative plaque volumetric). Hemodynamic and flow profiles of the internal thoracic arteries will be evaluated additionally with US. These parameters will be measured pre-CABG.\n\nMorbidity will be evaluated using quality of life questionnaires (EQ-5D-3L, IPAQ). Major adverse cardiovascular events (MACE) will be the primary endpoint. The atherosclerotic burden will be compared with established risk scores (EuroSCORE, STS-Score, SYNTAX Score, FORECAST.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients, who are are listed for elective CABG at the Medical University Innsbruck will be screened and recruited.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pre CABG\n\nExclusion Criteria:\n\n* no consent, prior carotid intervention'}, 'identificationModule': {'nctId': 'NCT03774004', 'acronym': 'ByPlaque', 'briefTitle': 'Plaque Burden Pre- Myocardial Revascularisation', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'Association of Peripheral Atherosclerotic Burden With the Short-term and Long-term Outcome in Patients With Elective Myocardial Revascularisation', 'orgStudyIdInfo': {'id': '1098/2017'}}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'Medical University of Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'overallOfficials': [{'name': 'Peter Marschang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University Innsbruck'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}