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Switching From Cigarettes to Heated Tobacco and Heart Artery Narrowing

Tests switching from cigarettes to heated tobacco in adults with coronary artery disease who smoke.

Key facts

Who runs it
National Institute of Cardiology, Warsaw, Poland
Where
Warsaw, PolandSee the site
Trial code
Registry title
Effects of Switching From Cigarettes to Tobacco Heating System on Coronary Atherosclerosis Progression
Status
Recruiting
People taking part
180 people, planned
Started
9 Feb 2023
Planned end
31 Dec 2025
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • heated tobacco - lifestyle intervention
Record updated
19 December 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult smokers with stable coronary artery disease who cannot or will not quit smoking. It compares switching to a heated tobacco product with continued cigarettes.

Age
Over 18 and under 75 years
Sex
All sexes
Disease stage
Stable chronic coronary syndrome: at least one coronary artery narrowing of 20% or more, seen on a coronary CT scan, in an artery wider than 2.0 mm
Earlier treatment
Stable treatment for coronary atherosclerosis according to the guidelines. Has been advised to quit smoking and still does not want to set a quit date within 30 days.
Biomarker or test result
Urine cotinine test of 200 ng/mL or more to confirm current smoking

Main reasons for not taking part

  • Heart attack, stroke, unstable angina or other acute cardiovascular event, or revascularization, within 30 days
  • Planned or previous coronary bypass surgery (CABG), or planned coronary intervention (PCI)
  • Heart failure with ejection fraction under 50%
  • Diabetes
  • Pregnant, breast-feeding or planning pregnancy

The registry criteria, word for word

Show all 26 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Any acute cardiovascular event (i.e. ACS, MI, Stroke, TIA, Limb ischemia), unstable angina or revascularization within 30 days prior to screening
  • Previous CABG
  • Subjects have previously participated in this study, or in an interventional study (drug or medical device) within 30 days of screening (participation in observational studies/registries allowed)
  • Severe uncontrolled hypertension (at the discretion of investigator)
  • Diabetes
  • 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
  • Subjects have any other clinical condition that would jeopardize the subject's safety while participating in this study, per Investigator's judgment
  • Preexisting heart failure with reduced ejection fraction (EF <50%)
  • GFR<45 ml/min/1,73 m2
  • Planned coronary intervention (PCI, CABG) at screening
  • Subjects with documented genetic familial hypercholesterolemia
  • Subjects who could not participate for any reason other than medical (e.g., psychological and/or social reason) per Investigator's judgment
  • Female subject is pregnant or breast-feeding, or planning to become pregnant during the study
  • Subjects have a close affiliation with the investigational site: a close relative of the investigator, a person dependent on the investigational site (e.g. employee or student of the investigational site)
  • Subjects are current or former employee of the tobacco industry or their first-degree relatives (parent, child, spouse)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in Poland

  • National Institute of CardiologyWarsaw, PolandContact: Cezary Kępka, MD PhDTaking people

About the trial

What the trial wants to find out

Objective:

Read full original descriptionShow less

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.

The 2 groups in the trial

  • combustion tobaccoNo study treatment, for comparison
  • heated tobaccoTreatment being tested

    Treatment: heated tobacco - lifestyle intervention

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effects of Switching From Cigarettes to Tobacco Heating System on Coronary Atherosclerosis Progression in Patients With Stable Coronary Artery Disease
Plain-language title
Switching From Cigarettes to Heated Tobacco and Heart Artery NarrowingGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05660798, who can take part
Record updated
19 December 2024