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

NCT ID: NCT03452124

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-30
• Study Completion Date: 2021-06-30

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.

Detailed Description

Two smokers groups matched for age and sex will be assessed:

1. a group of 30 current smokers with no diagnosed cardiovascular disease as the control group for chronic phase

2. a group of 30 current smokers with no diagnosed cardiovascular disease who will be using the I quit ordinary smoking (IQOS) for 1 month.

In the acute phase all 60 smokers will undergo a "sham" smoking for 7 minutes. Afterwards all 60 smokers will be randomized to smoke either a normal cigarette or IQOS and the after 60 minute washout period these subjects will be crossed over to the altenate mode of smoking (IQOS or normal cigarette respectively).

After the completion of the acute phase all 60 smokers will start the use of IQOS for one month.

In the acute phase, measurements will be performed at baseline, after sham smoking and after smoking of the normal cigarette or IQOS. The chronic phase measurements will be performed 1 month after use IQOS. Thirty current smokers of similar age and sex will serve as controls and will have measurements at baseline and 1 month after baseline assessment.

In both phases the investigators will assess: a) the aortic pulse wave velocity (PWV) and augmentation index (AIx) by Arteriograph and Complior; b) the perfusion boundary region of the sublingual arterial microvessels using Sideview, Darkfield imaging (Microscan, Glycocheck); c) the exhaled carbon monoxide (CO) level (parts per million -ppm) as a smoking status marker; d) the vital signs; e) an electrocardiogram; and f) plasma levels of C- reactive protein (CRP), transforming growth factor-b (TGF-b), lipoprotein associated phospholipase A2 (LP- LPA2), tumor necrosis factor- α (TNF-α), interleukins 6 and 10 (IL-6 and -10), procollagen propeptide type III (PIIINP), matrix metalloproteinase 2 and 9 (MMP-2 and -9), and macrophage-colony stimulating factor (MCSF), malondialdehyde (MDA) and protein carbonyls (PCs).

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

IQOS

I quit ordinary smoking (IQOS) assistes cessation program

Group Type: ACTIVE_COMPARATOR

I quit ordinary smoking (IQOS)

Intervention Type: DEVICE

I quit ordinary smoking (IQOS) assisted cessation program

Smoker control

Conventional cigarette smoking continuation

Group Type: ACTIVE_COMPARATOR

Conventional cigarette

Intervention Type: OTHER

Conventional cigarette smoking continuation

Interventions

I quit ordinary smoking (IQOS)

I quit ordinary smoking (IQOS) assisted cessation program

Intervention Type: DEVICE

Conventional cigarette

Conventional cigarette smoking continuation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Active conventional cigarette smoker

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Ignatios Ikonomidis

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ignatios Ikonomidis, MD

Role: PRINCIPAL_INVESTIGATOR

Attikon University General Hospital

Locations

"Attikon" University General Hospital

Athens, Attica, Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Ignatios Ikonomidis, MD

Role: CONTACT

ignoik@otenet.gr

00302105832187

George Pavlidis, MD

Role: CONTACT

geo_pavlidis@yahoo.gr

00302105832187

Facility Contacts

Ignatios Ikonomidis, MD

Role: primary

00302105832187

References

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.

Reference Type: DERIVED

PMID: 34083663 (View on PubMed)

Other Identifiers

IQOS-ATTIKON

Identifier Type: -

Identifier Source: org_study_id