Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-05 @ 3:12 PM
Study NCT ID:
NCT03671356
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2018-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Management in Interventional Cardiology - a Quality Management Single-center Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012307', 'term': 'Risk Factors'}], 'ancestors': [{'id': 'D012306', 'term': 'Risk'}, {'id': 'D011336', 'term': 'Probability'}, {'id': 'D013223', 'term': 'Statistics as Topic'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D015984', 'term': 'Causality'}, {'id': 'D015981', 'term': 'Epidemiologic Factors'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2067}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-14', 'studyFirstSubmitDate': '2018-08-21', 'studyFirstSubmitQcDate': '2018-09-13', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': '30 days', 'description': 'In-hospital mortality will be assessed and primarily reported'}], 'secondaryOutcomes': [{'measure': 'Bleeding (according to BARC bleeding definition)', 'timeFrame': '30 days and up to 5 years post procedure', 'description': 'in-hospital and long-term minor and major bleeding up to five years post procedure will be assessed and reported'}, {'measure': 'Acute and chronic kidney injury (according to KDIGO definitions)', 'timeFrame': '30 days and up to 5 years post procedure', 'description': 'in-hospital and long-term acute and chronic kidney injury up to five years post procedure will be assessed and reported'}, {'measure': 'TIA and Stroke', 'timeFrame': '30 days and up to 5 years post procedure', 'description': 'in-hospital and long-term cerebrovascular events (TIA and stroke) up to five years post procedure will be assessed and reported'}, {'measure': 'Quality of life (assessed by standardized QoL surveys)', 'timeFrame': '30 days and up to 5 years post procedure', 'description': 'in-hospital and long-term impact of interventional procedures on quality of life up to five years post procedure will be assessed and reported'}, {'measure': 'Long-term mortality', 'timeFrame': 'up to 5 years post procedure', 'description': 'long-term mortality up to five years post procedure will be assessed and report'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['risk score', 'risk management', 'NCDR', 'interventional cardiology'], 'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'The validity and applicability of different clinical risk scoring models in a variety of settings of interventional cardiology is evaluated in a retrospective and continuing prospective single-center registry at University Hospital Düsseldorf. Risk-adapted safety interventions are additionally tested.', 'detailedDescription': 'Beginning with a retrospective assessment of 2014-2017 and continuing with a prospective registry, clinical outcomes of interventional cardiac catheterization procedures at University Hospital Düsseldorf in a variety of settings (elective and emergency coronary procedures, structural and rhythmologic cardiac interventions etc.), will be evaluated. Different risk scoring models are recommended for risk stratification by cardiovascular societies (e.g. GRACE, CRUSADE, NCDR, ACEF, EUROScore scores) and will be evaluated for their applicability to contemporary and local clinical practice in interventional cardiology. Risk-adapted safety interventions (e.g. intensified monitoring, vascular access closure, renal protective measures) will be applied to all patients and will be evaluated for their impact on clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consenting adult patients undergoing cardiac catheterization at University Hospital Düsseldorf, Germany', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 yeas of age, written informed consent, cardiac catheterization at university hospital Düsseldorf, Germany\n\nExclusion Criteria:\n\n* no written informed consent'}, 'identificationModule': {'nctId': 'NCT03671356', 'acronym': 'NCDR', 'briefTitle': 'Risk Management in Interventional Cardiology - a Quality Management Single-center Registry', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Risk Management in Interventional Cardiology - a Quality Management Single-center Registry', 'orgStudyIdInfo': {'id': '18-007'}}, 'armsInterventionsModule': {'interventions': [{'name': 'risk score', 'type': 'OTHER', 'description': 'risk score'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Division of Cardiology, Pulmonary Disease and Vascular Medicine', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Malte Kelm, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Heinrich-Heine University, Duesseldorf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}