Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardiovascular Effects of Heated Tobacco Products (HTP) (ISMOKE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04550026
Recruitment Status : Recruiting
First Posted : September 15, 2020
Last Update Posted : September 15, 2020
Sponsor:
Information provided by (Responsible Party):
Magnus Lundbäck, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Heated Tobacco Products Microcirculation Thrombosis Vascular Function Blood Markers Microvesicles NETs Other: HTP inhalation Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Cardiovascular Effects of Heated Tobacco Products (HTP)
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : January 1, 2022

Arm Intervention/treatment
Experimental: Inhalation of HTP
Inhalation of HTP for 30 minutes
Other: HTP inhalation
Sham inhalation for 30 minutes
Other Name: HTP inhalation for 30 minutes

Active Comparator: Sham inhalation of HTP
Sham usage of HTP for 30 minutes
Other: HTP inhalation
Sham inhalation for 30 minutes
Other Name: HTP inhalation for 30 minutes




Primary Outcome Measures :
  1. microcirculation microcirculation [ Time Frame: change from baseline and 1 hour following exposures ]
    Iontophoresis and laser speckle contrast imaging (LSCI),

  2. thrombosis (total thrombus formation analysis system) [ Time Frame: change from baseline up to 3 hour following exposures] ]
    T-TAS (area under the curve, flow pressure change)

  3. arterial stiffness [ Time Frame: change from baseline up to 3 hour following exposures] ]
    PWV, PWA

  4. Microvesicles [ Time Frame: change from baseline up to 3 hour following exposures ]
    microvesicles of leukocyte, endothelial and platelet origin (MVs/microliter)

  5. NETs(neutrophil extracellular traps) [ Time Frame: change from baseline up to 3 hours following exposures ]
    blood levels of H3Cit using ELISA

  6. capillary microscopy [ Time Frame: change from baseline to 1 hour following exposures] ]
    capillary blood cell velocity, CBV, mm/s

  7. Endothelial progenitor cells [ Time Frame: change from baseline up to 3 hours following exposures ]
    EPC



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04550026


Contacts
Layout table for location contacts
Contact: Magnus Lundbäck, MD, PhD +46702433072 magnus.lundback@sll.se

Locations
Layout table for location information
Sweden
Institutionen för kliniska vetenskaper, Danderyds sjukhus Recruiting
Danderyd, Stockholm, Sweden, 18288
Contact: Tomas Jernberg, MD, Prof.    0046 8-123 550 17    tomas.jernberg@ki.se   
Principal Investigator: Magnus Lundbäck, MD, PhD         
Sponsors and Collaborators
Karolinska Institutet
Investigators
Layout table for investigator information
Study Director: Tomas Jernberg, MD, Prof Karolinska Institutet
Layout table for additonal information
Responsible Party: Magnus Lundbäck, MD, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04550026    
Other Study ID Numbers: 2020-03387
First Posted: September 15, 2020    Key Record Dates
Last Update Posted: September 15, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases