ESMOKE: Effects of E-smoke on Levels of Endothelial Progenitor Cells and Microparticles in Healthy Volunteers

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Completed
• CT.gov ID: NCT02532894
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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.

As a secondary endpoint we plan to investigate exhaled nitric oxide - a common inflammation marker used in asthmatic patients - after inhalation of electronic cigarette vapor.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: Electronic cigarette	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Esmoke Inhaling e-cigarette vapor	Device: Electronic cigarette; Inhaling e-cigarette vapor
No Intervention: Control

Outcome Measures

Primary Outcome Measures

1. Change in number of endothelial progenitor cells [24 hours]

2. Change in number of micro vesicles [24 hours]

Secondary Outcome Measures

1. Change in exhaled nitric oxide [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy subjects

• sporadic cigarette smoking (<9 cigarettes per month)

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.

• Active allergy within 4 weeks of the study

• Symptoms of infection or inflammation within 4 weeks of the study

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institutionen för kliniska vetenskaper, Danderyds sjukhus	Danderyd	Stockholm	Sweden	18288

Sponsors and Collaborators

• Karolinska Institutet

Investigators

• Principal Investigator: Magnus Lundbäck, MD, PhD, Institutionen för kliniska vetenskaper, Danderyds sjukhus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Magnus Lundbäck, MD, PhD,, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT02532894
• Other Study ID Numbers: 214/552-31/4
• First Posted: Aug 26, 2015
• Last Update Posted: Oct 11, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by Magnus Lundbäck, MD, PhD,, Karolinska Institutet: endothelial dysfunction; microvesicles; endothelial progenitor cells; electronic cigarettes

Study Results

No Results Posted as of Oct 11, 2021