Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT04450459
Status:
UNKNOWN
Last Update Posted:
2022-08-11
First Post:
2020-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Spiroergometer Parameters as Diagnostic Marker of Cardiac Ischemia in Pts. With Stable Angina Compared to FFR.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'EDTA Blood, Serum,'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-10', 'studyFirstSubmitDate': '2020-06-25', 'studyFirstSubmitQcDate': '2020-06-25', 'lastUpdatePostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'double slope sign of ΔV̇O2/ΔWR-Increase', 'timeFrame': 'baseline', 'description': 'double slope sign of ΔV̇O2/ΔWR by ergospirometer test'}]}, 'conditionsModule': {'keywords': ['FFR Measurement; exercise testing, ergospirometer'], 'conditions': ['Stable Angina']}, 'descriptionModule': {'briefSummary': 'In Patients with stable Angina pectoris CCS 1-3 exercise testing for ischemia detection is widely used despite the known limitations. Measurement of the FFR is invasive but gold standard for Ischemia detection.\n\nAdding of parameters of spiroergometer might help to improve diagnostic accuracy of non invasive exercise testing. Therefore the trial is evaluating diagnostic accuracy of spiroergometric parameters compared to invasive FFR measurement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with suspected CAD presenting for diagnostic testing/ coronary angiography', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stable Angina (CCS \\>1-3) with suspected CAD or\n* dyspnoea at exertion NYHA \\>2 or\n* signs of ischemia within SPECT or exercise electrocardiography\n* willingness to participate in the trial\n\nExclusion Criteria:\n\n* Unstable angina or myocardial infarction within the last 2 weeks\n* inability to perform bicycle exercise test\n* significant valvular disease\n* HOCM\n* av- block \\>I degree\n* asthma bronchiales'}, 'identificationModule': {'nctId': 'NCT04450459', 'acronym': 'ADVANCE', 'briefTitle': 'Impact of Spiroergometer Parameters as Diagnostic Marker of Cardiac Ischemia in Pts. With Stable Angina Compared to FFR.', 'organization': {'class': 'OTHER', 'fullName': 'Jena University Hospital'}, 'officialTitle': 'Impact of Ergospirometric Oxygen Uptake Under Exercise as Diagnostic Marker of Cardiac Ischemia in Patients With Stable Angina Compared to Non Invasive and Invasive (FFR) Measurement of Ischemia', 'orgStudyIdInfo': {'id': 'SMW 08'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ergospirometer test', 'type': 'DIAGNOSTIC_TEST', 'description': 'ergospirometric test will be done before cardiac catheterisation and invasive measurement of FFR'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07747', 'city': 'Jena', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sven Möbius-Winkler', 'role': 'CONTACT', 'email': 'Sven.Moebius-Winkler@med.uni-jena.de'}, {'name': 'Sissy Grund', 'role': 'CONTACT', 'email': 'sissy.grund@med.uni-jena.de'}, {'name': 'Nedim Memisevic, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'David Hanke, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ulf Teichgräber, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universityhospital', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'centralContacts': [{'name': 'Sven Möbius-Winkler, MD', 'role': 'CONTACT', 'email': 'Sven.Moebius-Winkler@med.uni-jena.de', 'phone': '0049-3641-9324503'}, {'name': 'Sissy Grund', 'role': 'CONTACT', 'email': 'sissy.grun@med.uni-jena.de'}], 'overallOfficials': [{'name': 'Sven Möbius-Winkler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universityhospital Jena'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jena University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}