NCT04175457

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 25, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

December 5, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2020

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

September 11, 2019

Last Update Submit

March 18, 2020

Conditions

E-cigarette UseMicrocirculationThrombosisVascular FunctionBlood MarkersMicrovesiclesNETs

Outcome Measures

Primary Outcomes (2)

  • microcirculation

    Iontophoresis and laser speckle contrast imaging (LSCI), Measurement of capillary blood flow (Capiflow), GlycoCheck system

    change from baseline and 1 hour following exposures

  • 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 Outcomes (4)

  • arterial stiffness

    change from baseline up to 3 hours following exposures

  • Microvesicles

    change from baseline, 30 minutes and 2 hour following exposures

  • NETs(neutrophil extracellular traps)

    change from baseline, 30 minutes and 2 hour following exposures

  • capillary microscopy

    change from baseline to 1 hour following exposures

Study Arms (2)

e-cigarette inhalation with nicotine

EXPERIMENTAL

inhalation of e-cigarette vapor with nicotine for 30 minutes.

Other: e-cigarette

e-cigarette inhalation without nicotine

ACTIVE COMPARATOR

inhalation of e-cigarette vapor without nicotine for 30 minutes.

Other: e-cigarette

Interventions

e-cigaretteOTHER

E-cigarette inhalation for 30 minutes using e-cigarette with and without nicotine

e-cigarette inhalation with nicotinee-cigarette inhalation without nicotine

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal health declaration

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institutionen för kliniska vetenskaper, Danderyds sjukhus

Danderyd, Stockholm County, 18288, Sweden

Location

Related Publications (2)

  • Kabele M, Lyytinen G, Bosson JA, Hedman L, Antoniewicz L, Lundback M, Mobarrez F. Nicotine in E-cigarette aerosol may lead to pulmonary inflammation. Respir Med. 2025 Jun;242:108101. doi: 10.1016/j.rmed.2025.108101. Epub 2025 Apr 14.

    PMID: 40239848DERIVED

  • Lyytinen G, Brynedal A, Anesater E, Antoniewicz L, Blomberg A, Wallen H, Bosson JA, Hedman L, Mobarrez F, Tehrani S, Lundback M. Electronic Cigarette Vaping with Nicotine Causes Increased Thrombogenicity and Impaired Microvascular Function in Healthy Volunteers: A Randomised Clinical Trial. Cardiovasc Toxicol. 2023 Aug;23(7-8):255-264. doi: 10.1007/s12012-023-09802-9. Epub 2023 Aug 7.

    PMID: 37548804DERIVED

MeSH Terms

Conditions

VapingThrombosis

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

SmokingBehaviorEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Erik Näslund, MD, Prof

    Karolinska Institutet, Danderyd Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Associate Professor

Study Record Dates

First Submitted

September 11, 2019

First Posted

November 25, 2019

Study Start

December 5, 2019

Primary Completion

January 27, 2020

Study Completion

January 27, 2020

Last Updated

March 19, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)