Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-05 @ 5:46 PM
Study NCT ID:
NCT00479804
Status:
COMPLETED
Last Update Posted:
2008-06-05
First Post:
2007-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Invasive Determination of Cardiac Output by Inertgas Rebreathing Method
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013147', 'term': 'Spirometry'}], 'ancestors': [{'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 311}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-04', 'studyFirstSubmitDate': '2007-05-25', 'studyFirstSubmitQcDate': '2007-05-25', 'lastUpdatePostDateStruct': {'date': '2008-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['indication for CMR'], 'conditions': ['Cardiac Diseases']}, 'descriptionModule': {'briefSummary': 'The cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac diseases. The current standard methods for the determination of the CO, however, are either invasive (e.g. right heart catheterization) or technically expendable and expensive (magnetic resonance tomography, MRT). The traditional non-invasive methods of determining the CO by rebreathing of carbon dioxide are easily carried out but suffer from methodical inaccuracies. Therefore the aim of the study at hand was to evaluate a new method for determining the CO by means of the inert gas rebreathing method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '14 Years', 'studyPopulation': 'Consecutive patients with indication for CMR', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for CMR\n* Ability of following instructions for rebreathing test'}, 'identificationModule': {'nctId': 'NCT00479804', 'acronym': 'NICO', 'briefTitle': 'Non-Invasive Determination of Cardiac Output by Inertgas Rebreathing Method', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsmedizin Mannheim'}, 'officialTitle': 'Non-Invasive Determination of Cardiac Output by the Inertgas Rebreathing Method Compared With Magnetic Resonance Tomography', 'orgStudyIdInfo': {'id': '2006-067M-MA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'inertgas rebreathing', 'type': 'DEVICE', 'description': 'determination of cardiac output by inertgas rebreathing'}, {'name': 'spirometry', 'type': 'DEVICE', 'description': 'spirometry for testing the ventilatory function'}, {'name': 'cardiac magnetic resonance imaging (CMR)', 'type': 'DEVICE', 'description': 'CMR examination which delivers the hemodynamic reference parameters'}]}, 'contactsLocationsModule': {'locations': [{'zip': '68167', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': '1st Department of Medicine, University Hospital Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'overallOfficials': [{'name': 'Joachim Saur, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': '1st Department of Medicine'}, {'name': 'Jens Kaden, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': '1st Deparment of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsmedizin Mannheim', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Joachim Saur', 'oldOrganization': 'University Hospital Mannheim'}}}}