Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-02-28 @ 10:23 PM
Study NCT ID:
NCT02127333
Status:
COMPLETED
Last Update Posted:
2014-12-16
First Post:
2014-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Oxygen for Vascular Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-14', 'studyFirstSubmitDate': '2014-04-29', 'studyFirstSubmitQcDate': '2014-04-29', 'lastUpdatePostDateStruct': {'date': '2014-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Plasma nitrite concentration', 'timeFrame': 'Baseline'}], 'primaryOutcomes': [{'measure': 'Flow-mediated dilation of the brachial artery', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Forearm blood flow', 'timeFrame': 'Baseline'}, {'measure': 'Laser doppler perfusion', 'timeFrame': 'Baseline'}, {'measure': 'Intima-media thickness of the brachial artery', 'timeFrame': 'Baseline'}, {'measure': 'Fractional diameter change of the brachial artery', 'timeFrame': 'Baseline'}, {'measure': 'Endothelium-independent vasodilation of the brachial artery', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic obstructive pulmonary disease', 'Coronary artery disease', 'Endothelial function'], 'conditions': ['Endothelial Dysfunction', 'FMD', 'IMT', 'Microcirculation', 'Oxygen Pressure', 'Carbon Dioxide Pressure', 'Oxygen Saturation', 'Forced Expiratory Volume After 1 Second']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uniklinik-duesseldorf.de/kardiologie', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Hypoxemia may contribute increased morbidity and mortality in chronic obstructive pulmonary disease (COPD) patients. We aim to characterize the role of acute and chronic hypoxemia for vascular function. For this purpose we measure capillary oxygen concentration and vascular.\n\nVascular function is assessed by flow-mediated dilation oft he brachial artery, forearm blood flow and laser doppler perfusion imaging.\n\nWe hypothesize that hypoxemia leads to impaired vascular function.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'CAD patients with or without COPD; healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stable coronary artery disease\n* stable chronic obstructive pulmonary disease\n\nExclusion Criteria:\n\n* acute myocardial infarction within 30 days\n* acute exacerbated COPD within 30 days\n* acute infections\n* severe acute or chronic renal failure\n* severe heart failure\n* atrial fibrillation\n* severe cardiac arrhythmia\n* hypotension\n* active malignant disease\n* active rheumatic disease\n* pulmonary hypertension with vasoactive therapy'}, 'identificationModule': {'nctId': 'NCT02127333', 'briefTitle': 'Role of Oxygen for Vascular Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Role of Acute and Chronic Hypoxemia for Vascular Function', 'orgStudyIdInfo': {'id': 'COPD_pO2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CAD patients with COPD'}, {'label': 'CAD patients without COPD'}, {'label': 'healthy volunteers'}]}, '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': 'Christian Heiss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Cardiology, Pulmonary Disease and Vascular Medicine'}, {'name': 'Malte Kelm, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Division of Cardiology, Pulmonary Disease and Vascular Medicineine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinik für Kardiologie, Pneumologie und Angiologie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Division of Cardiology, Pulmonary Diseases, Vascular Medicine', 'investigatorFullName': 'Klinik für Kardiologie, Pneumologie und Angiologie', 'investigatorAffiliation': 'Heinrich-Heine University, Duesseldorf'}}}}