NCT04550026

Brief Summary

This is a human randomized controlled cross-over study where the effects of heated tobacco products (HTP) 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
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

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 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

October 11, 2021

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

September 9, 2020

Last Update Submit

October 8, 2021

Conditions

Heated Tobacco ProductsMicrocirculationThrombosisVascular FunctionBlood MarkersMicrovesiclesNETs

Outcome Measures

Primary Outcomes (7)

  • microcirculation microcirculation

    Iontophoresis and laser speckle contrast imaging (LSCI),

    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 up to 3 hour following exposures]

  • arterial stiffness

    PWV, PWA

    change from baseline up to 3 hour following exposures]

  • Microvesicles

    microvesicles of leukocyte, endothelial and platelet origin (MVs/microliter)

    change from baseline up to 3 hour following exposures

  • NETs(neutrophil extracellular traps)

    blood levels of H3Cit using ELISA

    change from baseline up to 3 hours following exposures

  • capillary microscopy

    capillary blood cell velocity, CBV, mm/s

    change from baseline to 1 hour following exposures]

  • Endothelial progenitor cells

    EPC

    change from baseline up to 3 hours following exposures

Study Arms (2)

Inhalation of HTP

EXPERIMENTAL

Inhalation of HTP for 30 minutes

Other: HTP inhalation

Sham inhalation of HTP

ACTIVE COMPARATOR

Sham usage of HTP for 30 minutes

Other: HTP inhalation

Interventions

HTP inhalationOTHER

Sham inhalation for 30 minutes

Also known as: HTP inhalation for 30 minutes
Inhalation of HTPSham inhalation of HTP

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

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Tomas Jernberg, MD, Prof

    Karolinska Institutet

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 9, 2020

First Posted

September 16, 2020

Study Start

November 1, 2020

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

October 11, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)