Thrombosis Clinical Trial
Official title:
The Acute Effects of E-cigarette Inhalation on Vascular Function, Microcirculation and Thrombosis
Verified date | March 2020 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a human randomized controlled cross-over study where the effects of e-cigarette inhalation (with or without nicotine) on vascular function, microcirculation and thrombosis is assessed.
Status | Completed |
Enrollment | 22 |
Est. completion date | January 27, 2020 |
Est. primary completion date | January 27, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Normal health declaration Exclusion Criteria: - Any form of cardiovascular disease - Any form of pulmonary disease like asthma or COPD - Any form of systemic or chronic disorder like rheumatologic or metabolic diseases. - Symptoms of infection or inflammation within 4 weeks of the study - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Sweden | Institutionen för kliniska vetenskaper, Danderyds sjukhus | Danderyd | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Umeå University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | microcirculation | Iontophoresis and laser speckle contrast imaging (LSCI), Measurement of capillary blood flow (Capiflow), GlycoCheck system | change from baseline and 1 hour following exposures | |
Primary | thrombosis (total thrombus formation analysis system) | T-TAS (area under the curve, flow pressure change) | change from baseline, 30 minutes and 2 hour following exposures | |
Secondary | arterial stiffness | Photopletysmography (PPG), arteriographyTensioMed, Budapest, Hungary,Sphygmocor AtCor Medical, EndoPAT (Itamar) | change from baseline up to 3 hours following exposures | |
Secondary | Microvesicles | microvesicles of leukocyte, endothelial and platelet origin (MVs/microliter) | change from baseline, 30 minutes and 2 hour following exposures | |
Secondary | NETs(neutrophil extracellular traps) | blood levels of H3Cit using ELISA | change from baseline, 30 minutes and 2 hour following exposures | |
Secondary | capillary microscopy | capillary blood cell velocity, CBV, mm/s | change from baseline to 1 hour following exposures |
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