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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03452124
• Other study ID #: IQOS-ATTIKON
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: April 2020
• Source: University of Athens
• Contact: Ignatios Ikonomidis, MD
• Phone: 00302105832187
• Email: ignoik[@]otenet.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Active conventional cigarette smoker

Exclusion Criteria:

• Health condition adversely affected by smoking

• History or presence of cardiovascular disease

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Device:
• I quit ordinary smoking (IQOS)
I quit ordinary smoking (IQOS) assisted cessation program

Other:
• Conventional cigarette
Conventional cigarette smoking continuation

Locations

Country	Name	City	State
Greece	"Attikon" University General Hospital	Athens	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Acute I quit ordinary smoking (IQOS) effects on platelet activation.	Platelet activation was estimated by measuring blood levels of Thromboxane B2 (Thromboxane B2 EIA Kit Cayman Ann Arbor MI USA) A commercially available ELISA kit was used with an assay range 1.6-1000 pg/ml.	7 minutes
Secondary	Chronic I quit ordinary smoking (IQOS) effects on myocardial work.	Myocardial work (MW) was estimated by combining echo-derived left ventricular (LV) strain with brachial blood pressure to construct LV strain-pressure curves non-invasively. Brachial cuff systolic pressure measurements provide the peak systolic LV pressure value, which is combined with the input of valvular timing events that define isovolumetric and ejection phases, allowing the construction of an LV-pressure curve. This is combined with LV strain data into a pressure-strain loop (PSL), the area within which represents MW. Global MW index (GWI) is defined as the work within the LV PSL from mitral valve closure to mitral valve opening, while constructive MW (GCW) is the component of MW that contributes to LV ejection. On the contrary, wasted MW (GWW) is the work wasted as myocyte lengthening during systole, which does not contribute to LV ejection. MW efficiency (GWE) is defined as the ratio of GCW to the sum of GCW and GWW [GWE= GCW/ (GCW+GWW)].	1 month
Secondary	Chronic I quit ordinary smoking (IQOS) effects on arterial stiffness.	Arterial stiffness was estimated by calculating Total arterial compliance (TAC). TAC was evaluated utilising the stroke volume (SV) to pulse pressure (PP) ratio (SV/PP), based on the two-element Windkessel model; SV measurements were derived from two-dimensional echocardiography.	1 month
Secondary	Chronic I quit ordinary smoking (IQOS) effects on platelet activation.	Platelet activation was estimated by measuring blood levels of Thromboxane B2 (Thromboxane B2 EIA Kit Cayman Ann Arbor MI USA) A commercially available ELISA kit was used with an assay range 1.6-1000 pg/ml.	1 month