Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05660798

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

Led by National Institute of Cardiology, Warsaw, Poland · Updated on 2024-12-19

180

Participants Needed

1

Research Sites

150 weeks

Total Duration

On this page

Sponsors

N

National Institute of Cardiology, Warsaw, Poland

Lead Sponsor

P

PMPSA

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged >18 years and <75 years
  • Stable chronic coronary syndrome with at least one coronary artery stenosis ≥20% visible on coronary computed tomography angiography
  • History of smoking with at least 10 pack-years
  • Current smokers who smoke more than 10 cigarettes per day for at least 6 months prior to screening, verified by urinary cotinine test
  • Patients advised to quit smoking but unwilling to set a quit date within the next 30 days
  • Stable treatment for coronary atherosclerosis according to guidelines
  • Signed informed consent and understood the study
Not Eligible

You will not qualify if you...

  • Acute cardiovascular event (such as ACS, MI, Stroke, TIA, Limb ischemia), unstable angina, or revascularization within 30 days before screening
  • Planned coronary intervention like PCI or CABG at screening
  • Previous coronary artery bypass graft surgery (CABG)
  • Heart failure with reduced ejection fraction below 50%
  • Severe uncontrolled hypertension
  • Diabetes
  • Documented familial hypercholesterolemia
  • Serious infection or chronic inflammatory systemic disease
  • Non-cardiovascular disease with poor prognosis (e.g., metastatic cancer)
  • Active cancer or cancer history within the last 5 years
  • Hypersensitivity to tobacco heating system or iodine contrast agents
  • Glomerular filtration rate less than 45 ml/min/1.73 m2
  • Inability to participate due to psychological or social reasons
  • Any clinical condition jeopardizing safety during the study
  • Pregnancy, breastfeeding, or planning pregnancy during the study
  • Previous participation in this study or interventional study within 30 days
  • Close affiliation with investigational site staff or investigators
  • Current or former tobacco industry employees or their first-degree relatives

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Trial Site Locations

Total: 1 location

1

National Institute of Cardiology

Warsaw, Poland, 04-628

Actively Recruiting

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Research Team

C

Cezary Kepka, ND PhD

CONTACT

M

Mariusz Kruk, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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