Effects of Switching From Cigarettes to Tobacco Heating System on Coronary Atherosclerosis Progression

NCT05660798 | Recruiting DMC

• 1 other identifier: SWITCH01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To evaluate the impact of heated versus combustion tobacco products on progression of atherosclerosis in patients with CAD unable(unwilling) to quit smoking. Rationale: Despite the efforts to curb smoking and full awareness of its deleterious health impact, smoking remains a significant contributor to morbidity and mortality. Some health impact of smoking may be improved by other forms of cigarettes than traditional combustion, especially for subjects unwilling or unable to stop smoking. As recently as 2020, one of heated tobacco products (HTP)(IQOS) was FDA Authorized as a 'Reduced Exposure' product. The available evidence to date allows to conclude that the IQOS system heats tobacco but does not burn it, which significantly reduces the production of harmful and potentially harmful chemicals. Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduced body's exposure to harmful or potentially harmful chemicals. There is also evidence indicating lower levels of inflammatory markers and improved vascular function associated with use of heated tobacco products. However, it is unknown whether the reduction in the exposure translates into potential reduction of harm within cardiovascular system, as compared to the traditional (combustion) cigarettes. The evidence is of crucial importance for patients with cardiovascular diseases, medical community, and national health authorities planning evidence based policies regarding HTP/cigarettes.

Conditions

Coronary Artery Disease; Coronary Atherosclerosis; Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

• Change in non calcified plaque volume between H and C groups ("intention to treat")

  CCTA based evaluation

  0-18 months

Secondary Outcomes (18)

• Change in total plaque volume

  0-18 months

• Change in plaque volume components (low attenuation, fibrous-fatty, fibrous, non-calcified plaque, calcified plaque)

  0-18 months

• Change in non calcified plaque volume between H and C groups ("as treated")

  0-18 months

• Change in lipid metabolism

  0-18 months

• Change in oxidative stress

  0-18 months

Study Arms (2)

combustion tobacco

NO INTERVENTION

heated tobacco

EXPERIMENTAL

Behavioral: heated tobacco - lifestyle intervention

Interventions

heated tobacco - lifestyle intervention BEHAVIORAL

Patients unable (unwilling) to stop smoking will be randomized to either combustion (C) or heated (H) tobacco groups.

heated tobacco

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged \>18 years and \<75 years
• Subjects with stable chronic coronary syndrome defined as the presence of at least one coronary artery stenosis \>=20% due to coronary plaque visible on coronary computed tomography angiography (CCTA), in an artery with a reference diameter \> 2.0mm
• History of smoking pack-years ≥10 (Pack-years will be calculated by taking the average number of cigarettes smoked per day divided by 20 and multiplied by the number of years smoked), based on self-reporting
• Current smokers with a minimum of self-reported current smoking pattern of \>10 cigarettes/day during the last 6 months prior to screening, smoking status will be verified based on a urinary cotinine test (cotinine ≥200 ng/mL)
• Patients that have been advised to quit smoking and informed of a smoking risk and cessation programs (per local SOC) and who are still not willing to set a quit date within the next 30 days at screening
• Stable treatment for coronary atherosclerosis according to the guidelines
• Have understood the study and have signed informed consent

You may not qualify if:

• Any acute cardiovascular event (i.e. ACS, MI, Stroke, TIA, Limb ischemia), unstable angina or revascularization within 30 days prior to screening
• Planned coronary intervention (PCI, CABG) at screening
• Previous CABG
• Preexisting heart failure with reduced ejection fraction (EF \<50%)
• Severe uncontrolled hypertension (at the discretion of investigator)
• Diabetes
• Subjects with documented genetic familial hypercholesterolemia
• Subjects have known serious infection or chronic inflammatory systemic disease (e.g. rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis)
• Subjects have a known non-cardiovascular disease that is associated with poor prognosis (e.g. metastatic cancer)
• Patient with currently active cancer or history of cancer within the last 5 years
• Subjects have hypersensitivity or any other warnings listed in the local labeling for THS
• Subjects have hypersensitivity to imaging iodine contrast agents
• GFR\<45 ml/min/1,73 m2
• Subjects who could not participate for any reason other than medical (e.g., psychological and/or social reason) per Investigator's judgment
• Subjects have any other clinical condition that would jeopardize the subject's safety while participating in this study, per Investigator's judgment

Sponsors & Collaborators

• National Institute of Cardiology, Warsaw, Poland: lead
• PMPSA: collaborator

Study Sites (1)

National Institute of Cardiology

Warsaw, 04-628, Poland

RECRUITING

Related Publications (2)

• Biondi-Zoccai G, Sciarretta S, Bullen C, Nocella C, Violi F, Loffredo L, Pignatelli P, Perri L, Peruzzi M, Marullo AGM, De Falco E, Chimenti I, Cammisotto V, Valenti V, Coluzzi F, Cavarretta E, Carrizzo A, Prati F, Carnevale R, Frati G. Acute Effects of Heat-Not-Burn, Electronic Vaping, and Traditional Tobacco Combustion Cigarettes: The Sapienza University of Rome-Vascular Assessment of Proatherosclerotic Effects of Smoking ( SUR - VAPES ) 2 Randomized Trial. J Am Heart Assoc. 2019 Mar 19;8(6):e010455. doi: 10.1161/JAHA.118.010455.

  PMID: 30879375 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Cezary Kepka, ND PhD

CONTACT

+48223434150; ckepka@ikard.pl

Mariusz Kruk, MD PhD

CONTACT

+48223434342; mkruk@ikard.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: December 21, 2022
• Study Start: February 9, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)