Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT03137550
Status:
COMPLETED
Last Update Posted:
2022-05-31
First Post:
2017-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Use of Multiple Biomarkers With Stress Testing to Detect Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 850}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-27', 'studyFirstSubmitDate': '2017-04-28', 'studyFirstSubmitQcDate': '2017-04-28', 'lastUpdatePostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of coronary artery disease', 'timeFrame': 'Within the initial diagnostic evaluation process (maximum within 30 days)', 'description': 'The diagnosis of coronary artery disease through stress testing alone and combined with cardiac biomarkers.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Main aim of the COMBAT-CAD-Study is to clarify, if the combination of stress testing with biomarkers improves the diagnostic accuracy.\n\nHypothesis of our study is that diagnosis of CAD can be improved by adding biomarkers to solely stress testing for the workup of patients with suspected CAD or progress of already known CAD.', 'detailedDescription': 'The COMBAT-CAD Study is an observational study with the aim to improve the diagnostic accuracy by a combination of stress testing with sensitive and specific biomarkers in detecting coronary artery disease or its progress. The main subjects are all patients with CAD or suspicion of CAD sent to the University Heart Center Hamburg. In these patients, ECG, laboratory examination, symptoms or transthoracic echocardiography in rest could not rule out CAD or progress of known CAD. The hypothesis of the study is that detection of CAD can be improved by adding biomarkers to stress testing for the diagnostic workup of patients with suspected CAD or progress of already known CAD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible are all patients who receive stress testing ordered by a physician of the University Heart Center and who are willing and able to participate in an observational study. Participants of interest are outpatients and inpatients of the University Heart Centre.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Every patient referred to coronary angiography, or diagnostic work-up with suspicion of CAD or progress of CAD (in case of CABG patients or already treated with PCI)\n\nExclusion Criteria:\n\n1. Insufficient knowledge of the German language (able to understand and write the German language)\n2. Physical or psychological incapability to take part in the investigation\n3. Persons with no sufficient language ability in German to understand the provided study information material.'}, 'identificationModule': {'nctId': 'NCT03137550', 'acronym': 'COMBAT-CAD', 'briefTitle': 'Combined Use of Multiple Biomarkers With Stress Testing to Detect Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Combined Use of Multiple Biomarkers With Stress Testing to Detect Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'PV4023'}}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Department of General and Interventional Cardiology, University Heart Center Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Stefan Blankenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of the Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}