Clinical trial NCT03452124: The Effects of I Quit Ordinary Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers
Official title: The Effects of I Quit Ordinary Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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).

Eligibility criteria: Inclusion Criteria:

* Active conventional cigarette smoker

Exclusion Criteria:

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

Primary outcomes:
measure: Acute I quit ordinary smoking (IQOS) effects on pulse wave velocity
timeFrame: 7 minutes
measure: Acute I quit ordinary smoking (IQOS) effects on Exhaled Carbon monoxide (CO)
timeFrame: 7 minutes
measure: Acute I quit ordinary smoking (IQOS) effects on endothelial glycocalyx thickness
timeFrame: 7 minutes
measure: Chronic I quit ordinary smoking (IQOS) effects on pulse wave velocity
timeFrame: 1 month
measure: Chronic I quit ordinary smoking (IQOS) effects on endothelial glycocalyx thickness
timeFrame: 1 month
measure: Chronic I quit ordinary smoking (IQOS) effects in left ventricular function
timeFrame: 1 month
measure: Chronic I quit ordinary smoking (IQOS) effects on endothelial function
timeFrame: 1 month
measure: Chronic I quit ordinary smoking (IQOS) effects on endothelial function
timeFrame: 1 month
measure: Chronic I quit ordinary smoking (IQOS) effects on Exhaled Carbon monoxide (CO)
timeFrame: 1 month
Secondary outcomes:
measure: Acute I quit ordinary smoking (IQOS) effects on platelet activation.
timeFrame: 7 minutes
measure: Chronic I quit ordinary smoking (IQOS) effects on myocardial work.
timeFrame: 1 month
measure: Chronic I quit ordinary smoking (IQOS) effects on arterial stiffness.
timeFrame: 1 month
measure: Chronic I quit ordinary smoking (IQOS) effects on platelet activation.
timeFrame: 1 month
Other outcomes:
Locations:
city: Athens
country: Greece
facility: "Attikon" University General Hospital
state: Attiki
Study officials:
affiliation: Attikon University General Hospital
name: Ignatios Ikonomidis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.