The Effects of I Quit Ordinary Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers

NCT03452124 | Unknown

• 1 other identifier: IQOS-ATTIKON
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

I quit ordinary smoking (IQOS) is proposed as a bridge to smoking cessation. In this study the investigators will examine its effects on aortic elasticity, glycocalyx integrity, and exhaled carbon monoxide (CO) concentration, both acutely and after 1 month of use.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (9)

• Acute I quit ordinary smoking (IQOS) effects on pulse wave velocity

  Acute I quit ordinary smoking (IQOS) effects on pulse wave velocity (PWV, m/s) using tonometry

  7 minutes

• Acute I quit ordinary smoking (IQOS) effects on Exhaled Carbon monoxide (CO)

  CO concentration was measured the exhaled carbon as parts per million-ppm by the device Smokerlyzer, Covita, Bedfont, CA, USA). Participants were instructed not to smoke the night before and the morning before the CO measurements and to hold their breath for 10 sec before exhaling to the mouthpiece.

  7 minutes

• Acute I quit ordinary smoking (IQOS) effects on endothelial glycocalyx thickness

  Acute I quit ordinary smoking (IQOS) effects on endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublinqual arterial microvessels

  7 minutes

• Chronic I quit ordinary smoking (IQOS) effects on pulse wave velocity

  Chronic I quit ordinary smoking (IQOS) effects on pulse wave velocity (PWV, m/s) using tonometry

  1 month

• Chronic I quit ordinary smoking (IQOS) effects on endothelial glycocalyx thickness

  Chronic I quit ordinary smoking (IQOS) effects on endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublinqual arterial microvessels

  1 month

• Chronic I quit ordinary smoking (IQOS) effects in left ventricular function

  Left Ventricular function is assessed by Global Longitudinal Strain by speckle tracking echocardiography

  1 month

• Chronic I quit ordinary smoking (IQOS) effects on endothelial function

  Endothelial function was assessed by measuring coronary flow reserve of Left anterior descending artery. Coronary flow reserve was estimated by Doppler echocardiography as the ratio of coranary flow velocity after bolus intravenous adenosine infusion to coronary flow velocity at rest.

  1 month

• Chronic I quit ordinary smoking (IQOS) effects on endothelial function

  Endothelial function was assessed by measuring Flow Mediated Vasodilation (FMD) using sonography. During a FMD test, vasodilation occurs following an acute increase in blood flow, typically induced via circulatory arrest in the arm (supra-systolic cuff occlusion) for a period of time. FMD is the percent of increase in brachial artery diameter after occlusion.

  1 month

• Chronic I quit ordinary smoking (IQOS) effects on Exhaled Carbon monoxide (CO)

  CO concentration was measured the exhaled carbon as parts per million-ppm by the device Smokerlyzer, Covita, Bedfont, CA, USA). Participants were instructed not to smoke the night before and the morning before the CO measurements and to hold their breath for 10 sec before exhaling to the mouthpiece.

  1 month

Secondary Outcomes (4)

• Acute I quit ordinary smoking (IQOS) effects on platelet activation.

  7 minutes

• Chronic I quit ordinary smoking (IQOS) effects on myocardial work.

  1 month

• Chronic I quit ordinary smoking (IQOS) effects on arterial stiffness.

  1 month

• Chronic I quit ordinary smoking (IQOS) effects on platelet activation.

  1 month

Study Arms (2)

IQOS

ACTIVE COMPARATOR

I quit ordinary smoking (IQOS) assistes cessation program

Device: I quit ordinary smoking (IQOS)

Smoker control

ACTIVE COMPARATOR

Conventional cigarette smoking continuation

Other: Conventional cigarette

Interventions

I quit ordinary smoking (IQOS) DEVICE

I quit ordinary smoking (IQOS) assisted cessation program

IQOS

Conventional cigarette OTHER

Conventional cigarette smoking continuation

Smoker control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Active conventional cigarette smoker

You may not qualify if:

• Health condition adversely affected by smoking
• History or presence of cardiovascular disease

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

"Attikon" University General Hospital

Athens, Attica, 12462, Greece

RECRUITING

Related Publications (1)

• Ikonomidis I, Vlastos D, Kostelli G, Kourea K, Katogiannis K, Tsoumani M, Parissis J, Andreadou I, Alexopoulos D. Differential effects of heat-not-burn and conventional cigarettes on coronary flow, myocardial and vascular function. Sci Rep. 2021 Jun 3;11(1):11808. doi: 10.1038/s41598-021-91245-9.

  PMID: 34083663 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Ignatios Ikonomidis, MD

  Attikon University General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ignatios Ikonomidis, MD

CONTACT

00302105832187; ignoik@otenet.gr

George Pavlidis, MD

CONTACT

00302105832187; geo_pavlidis@yahoo.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 25, 2018
• First Posted: March 2, 2018
• Study Start: March 30, 2018
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

GR (1)