Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT00831220
Status:
COMPLETED
Last Update Posted:
2009-01-28
First Post:
2009-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endothelial Dysfunction in Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma and serum.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-27', 'studyFirstSubmitDate': '2009-01-27', 'studyFirstSubmitQcDate': '2009-01-27', 'lastUpdatePostDateStruct': {'date': '2009-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'exacerbations', 'EPCs', 'Erythropoietin', 'C-RP', 'COPD and endothelial dysfunction'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'Endothelial Dysfunction']}, 'descriptionModule': {'briefSummary': 'Objective: To investigate the potential role of endothelial dysfunction as a pathogenic mechanism of cardiovascular events in COPD. Hypothesis: endothelial function is abnormal in patients with COPD, particularly during exacerbations of the disease. Design: prospective and controlled study performed in an university hospital. Population: we compare 4 groups of subjects, 44 patients with stable COPD, 35 patients with acute exacerbation of COPD, 10 smokers or former smokers with normal lung function and 10 never smokers matched by physical activity and BMI. Study variables: a) clinical variables: clinical information, physical examination, pulmonary function tests, ECG and sputum culture; b) Biological variables: number of Circulating Endothelial Progenitor Cells, vascular growth factors (vascular endothelial growht factor and erythropoietin), systemic inflammation (C-reactive protein, white blood cells), peripheral venous blood test (including hemogram, biochemical analysis with glycemia, cholesterol, LDLcol, HDLcol); and c) systemic vascular reactivity assessment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with an exacerbation of COPD admitted to our hospital, stable COPD recruited in an ambulatory basis, smokers or former smokers and never smokers recruited in our laboratory.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with moderate to very severe COPD admitted in the hospital because of an exacerbation, and,\n* Patients with moderate to very severe COPD in stable condition.\n\nExclusion Criteria:\n\n* Patients with an exacerbation of COPD who needed invasive or non invasive mechanical ventilation\n* Patients with other chronic inflammatory diseases.\n* Patients with other acute or active chronic systemic disease such as heart failure, renal insufficiency, etc.'}, 'identificationModule': {'nctId': 'NCT00831220', 'briefTitle': 'Endothelial Dysfunction in Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitari Son Dureta'}, 'officialTitle': 'Endothelial Dysfunction in Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'PI04/1946'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients with a COPD exacerbation'}, {'label': '2', 'description': 'Patients with stable COPD'}, {'label': '3', 'description': 'Smokers or former smokers'}, {'label': '4', 'description': 'Never smokers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07014', 'city': 'Palma Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'Hospital Universitari Son Dureta'}], 'overallOfficials': [{'name': 'Ernest Sala, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Servei de Pneumologia, Hospital Universitari Son Dureta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitari Son Dureta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondo de Investigacion Sanitaria', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. Ernest Sala', 'oldOrganization': 'Servei de Pneumologia, Hospital Universitari Son Dureta'}}}}