Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-30 @ 10:33 PM
Study NCT ID:
NCT00734266
Status:
COMPLETED
Last Update Posted:
2013-03-06
First Post:
2008-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Leukotrienes During Cardiac Surgery in Patients With Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-05', 'studyFirstSubmitDate': '2008-08-12', 'studyFirstSubmitQcDate': '2008-08-13', 'lastUpdatePostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'urine cysteinyl leukotriene', 'timeFrame': 'intra-operative'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['COPD', 'CPB', 'Leukotrienes'], 'conditions': ['Lung Dysfunction', 'Inflammatory Response During Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'The hypotheses of this study are that:\n\n* Production and release of inflammatory substances called leukotrienes are increased during heart surgery with use of a heart-lung machine in humans;\n* The increase in these leukotrienes levels after heart surgery is higher in patients with bronchitis and/or emphysema than in patients without previous history of lung disease;\n* Levels of leukotrienes are directly correlated with worsening of lung function during and after heart surgery.', 'detailedDescription': 'In this project, we will test the hypothesis that cys-leukotrienes are released and correlated with the impairment of the lung function after cardiac surgery in patients with COPD. If such hypothesis is substantiated in the study, it would allow us to propose the use of leukotriene inhibitors in the peri-operative period to improve pulmonary function and to decrease complications after cardiac surgery in COPD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients schedules to undergo cardiac surgery with use of CPB.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients schedules to undergo cardiac surgery with use of CPB.\n\nExclusion Criteria:\n\n* inability to provide consent;\n* previous diagnosis of asthma;\n* acute pre-operative respiratory failure;\n* emergency surgery.'}, 'identificationModule': {'nctId': 'NCT00734266', 'briefTitle': 'Changes in Leukotrienes During Cardiac Surgery in Patients With Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Changes in Leukotrienes During Cardiac Surgery in Patients With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': '2007-P-000164/7'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1 Control', 'description': 'Patients with and without chronic obstructive pulmonary disease diagnosed before scheduling for cardiac surgery.'}, {'label': '2 COPD', 'description': 'Patients with and without chronic obstructive pulmonary disease diagnosed before scheduling for cardiac surgery.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Marcos F Vidal Melo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anesthesia', 'investigatorFullName': 'Marcos Vidal Melo', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}