Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT02532894
Status:
COMPLETED
Last Update Posted:
2021-10-11
First Post:
2015-08-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of E-smoke on Levels of Endothelial Progenitor Cells and Microparticles in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072137', 'term': 'Vaping'}], 'ancestors': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-08', 'studyFirstSubmitDate': '2015-08-24', 'studyFirstSubmitQcDate': '2015-08-25', 'lastUpdatePostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in number of endothelial progenitor cells', 'timeFrame': '24 hours'}, {'measure': 'Change in number of micro vesicles', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Change in exhaled nitric oxide', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['endothelial dysfunction', 'microvesicles', 'endothelial progenitor cells', 'electronic cigarettes'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'We plan to investigate the acute effects of inhaling e-cigarette vapor on cell function measured by microvesicles and endothelial progenitor cells. Micro vesicles are released upon either activation or apoptosis from different cell types such as platelets, leucocytes and endothelial cell. Endothelial progenitor cells are a type of stem cells that circulate in the blood with the ability to differentiate to endothelial cells. Endothelial progenitor cells are inversely correlated to cardiovascular risk factors.\n\nAs a secondary endpoint we plan to investigate exhaled nitric oxide - a common inflammation marker used in asthmatic patients - after inhalation of electronic cigarette vapor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy subjects\n* sporadic cigarette smoking (\\<9 cigarettes per month)\n\nExclusion Criteria:\n\n* Any form of cardiovascular disease\n* Any form of pulmonary disease like asthma or COPD\n* Any form of systemic or chronic disorder like rheumatologic or metabolic diseases.\n* Active allergy within 4 weeks of the study\n* Symptoms of infection or inflammation within 4 weeks of the study\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02532894', 'acronym': 'ESMOKE', 'briefTitle': 'Effects of E-smoke on Levels of Endothelial Progenitor Cells and Microparticles in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'orgStudyIdInfo': {'id': '214/552-31/4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Esmoke', 'description': 'Inhaling e-cigarette vapor', 'interventionNames': ['Device: Electronic cigarette']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Electronic cigarette', 'type': 'DEVICE', 'description': 'Inhaling e-cigarette vapor', 'armGroupLabels': ['Esmoke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18288', 'city': 'Danderyd', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'Institutionen för kliniska vetenskaper, Danderyds sjukhus', 'geoPoint': {'lat': 59.40398, 'lon': 18.02376}}], 'overallOfficials': [{'name': 'Magnus Lundbäck, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institutionen för kliniska vetenskaper, Danderyds sjukhus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD,', 'investigatorFullName': 'Magnus Lundbäck', 'investigatorAffiliation': 'Karolinska Institutet'}}}}