Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT04599361
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2020-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Care Analysis on Myocardial Revascularization in Patients With Chronic Coronary Heart Disease (CHD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 385}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-28', 'studyFirstSubmitDate': '2020-09-11', 'studyFirstSubmitQcDate': '2020-10-21', 'lastUpdatePostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Guideline compliance', 'timeFrame': '2 years', 'description': 'Guidelines-compliant therapy in patients with chronic CHD (2- or 3-vessel or main vessel disease) according to German National Disease Management Guideline on chronic coronary heart disease'}], 'secondaryOutcomes': [{'measure': 'Heart teams', 'timeFrame': '2 years', 'description': 'Frequency and quality of heart teams'}, {'measure': 'Patient participation', 'timeFrame': '2 years', 'description': 'extent of patient participation in the decision making process'}, {'measure': 'Decision making process', 'timeFrame': '2 years', 'description': 'importance of clinical parameters in the decision-making process (e.g. syntax scores, iFR, FFR)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic coronary heart disease', 'myocardial revascularization', 'heart team', 'decision making', 'cardiology', 'heart surgery'], 'conditions': ['Coronary Heart Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://revask.de/', 'label': 'The official website of the REVASK project'}]}, 'descriptionModule': {'briefSummary': 'Myocardial infarction and chronic coronary heart disease (cCHD) are the most frequent causes of death in Germany. Treatment options include widening of the narrowed / blocked coronary vessel via catheter and stent or bypass surgery in which the narrowed vessel sites are bridged. The "German National Disease Management Guideline on cCHD" helps doctors to decide which treatment is most appropriate for the severity of vascular damage and possible concomitant diseases of the patient. Nevertheless, there are other factors determining treatment decision. For example, the equipment or preferences of the hospital or department in which patients are admitted, play a role in the decision.\n\nThe aim of the REVASK project is to investigate whether and to what extent the collaboration of cardiology and heart surgery specialists in so-called "heart teams" influences the decision on therapy.\n\nFor this purpose, doctors and patients will be interviewed about how the treatment decision was made and how satisfied both sides are with the outcome of the treatment and the decision. In addition, claims data from several German health insurance companies (Techniker, BARMER, Betriebs- und Innungskrankenkassen) will be analyzed. Treatment data, which is documented as usual by the treating medical staff and passed on to the health insurance companies for accounting purposes, is used. Furthermore, treatment data recorded in the registers of the professional societies is analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'outpatient cardiology practices, hospitals with a cardiology department and hospitals with a cardiology and heart surgery department (n=20) in Germany', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* with chronic coronary heart disease\n* and 2- or 3-vessel or main-vessel disease\n* who are being treated at one of the recruitment sites\n* with a promptly planned intervention for myocardial revascularization\n* who are insured with pre-specified German health insurance companies (BARMER or TK)\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04599361', 'acronym': 'REVASK', 'briefTitle': 'Health Care Analysis on Myocardial Revascularization in Patients With Chronic Coronary Heart Disease (CHD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'InGef - Institute for Applied Health Research Berlin GmbH'}, 'officialTitle': 'Health Care Analysis on Myocardial Revascularization in Patients With Chronic Coronary Heart Disease (CHD)', 'orgStudyIdInfo': {'id': '01VSF18010'}, 'secondaryIdInfos': [{'id': 'DRKS00022175', 'type': 'REGISTRY', 'domain': 'German clinical trials register'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with CHD', 'description': 'outpatient cardiology practices, hospitals with a cardiology department and hospitals with a cardiology and heart surgery department (n=20) in Germany Patients with chronic coronary heart disease and 2- or 3-vessel or main-vessel disease who are being treated at one of the recruitment sites with a promptly planned intervention for myocardial revascularization who are insured with pre-specified German health insurance companies (BARMER or TK)\n\nPatients will receive questionnaires.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Pädagogische Hochschule Freiburg Public Health & Health Education', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}], 'overallOfficials': [{'name': 'Jochen Walker, Dr. med.', 'role': 'STUDY_CHAIR', 'affiliation': 'InGef - Institute for Applied Health Research Berlin GmbH; Spittelmarkt 12, 10117 Berlin'}, {'name': 'Andreas Beckmann, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie (DGTHG)'}, {'name': 'Uwe Zeymer, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stiftung Institut für Herzinfarktforschung (IHF)'}, {'name': 'Peter Ihle', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PMV forschungsgruppe, Universitätsklinikum Köln'}, {'name': 'Ursula Marschall, Dr.med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BARMER'}, {'name': 'Ines Meier, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Techniker Krankenkasse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Research data can be shared with persons or institutions with a legitimate scientific interest after consultation in the consortium and only in pseudonymised form and within the scope of the EU-GDPR'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InGef - Institute for Applied Health Research Berlin GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Education Freiburg', 'class': 'UNKNOWN'}, {'name': 'Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie (DGTHG)', 'class': 'UNKNOWN'}, {'name': 'Stiftung Institut fuer Herzinfarktforschung', 'class': 'OTHER'}, {'name': 'Universitätsklinikum Köln', 'class': 'OTHER'}, {'name': 'BARMER', 'class': 'OTHER'}, {'name': 'Techniker Krankenkasse', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}