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

Launched by NATIONAL INSTITUTE OF CARDIOLOGY, WARSAW, POLAND · Dec 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of switching from traditional cigarettes to a heated tobacco product called IQOS on the progression of coronary artery disease (CAD). The goal is to understand whether using this heated tobacco system, which heats rather than burns tobacco, can reduce harmful effects on the heart compared to regular cigarettes. This research is particularly important for smokers who are not ready or willing to quit smoking entirely but still want to improve their heart health.

To participate in the trial, you need to be an adult aged between 18 and 75 years and have a history of stable coronary artery disease, which means there's some narrowing in your arteries but you're not experiencing severe symptoms. You should also be a current smoker, consuming at least 10 cigarettes a day for the last six months, and have been advised to quit smoking but have not set a quit date. If you join the study, you can expect to undergo tests to monitor your heart health and receive support regarding your smoking habits. It’s essential to understand that this trial is focusing on how changing your smoking method might affect your heart over time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults aged \>18 years and \<75 years
• • 2. 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
• • 3. 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
• • 4. 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)
• • 5. 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
• • 6. Stable treatment for coronary atherosclerosis according to the guidelines
• • 7. Have understood the study and have signed informed consent
• Exclusion Criteria:
• • 1. Any acute cardiovascular event (i.e. ACS, MI, Stroke, TIA, Limb ischemia), unstable angina or revascularization within 30 days prior to screening
• • 2. Planned coronary intervention (PCI, CABG) at screening
• • 3. Previous CABG
• • 4. Preexisting heart failure with reduced ejection fraction (EF \<50%)
• • 5. Severe uncontrolled hypertension (at the discretion of investigator)
• • 6. Diabetes
• • 7. Subjects with documented genetic familial hypercholesterolemia
• • 8. Subjects have known serious infection or chronic inflammatory systemic disease (e.g. rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis)
• • 9. Subjects have a known non-cardiovascular disease that is associated with poor prognosis (e.g. metastatic cancer)
• • 10. Patient with currently active cancer or history of cancer within the last 5 years
• • 11. Subjects have hypersensitivity or any other warnings listed in the local labeling for THS
• • 12. Subjects have hypersensitivity to imaging iodine contrast agents
• • 13. GFR\<45 ml/min/1,73 m2
• • 14. Subjects who could not participate for any reason other than medical (e.g., psychological and/or social reason) per Investigator's judgment
• • 15. Subjects have any other clinical condition that would jeopardize the subject's safety while participating in this study, per Investigator's judgment
• • 16. Female subject is pregnant or breast-feeding, or planning to become pregnant during the study
• • 17. 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)
• • 18. 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)
• • 19. Subjects are current or former employee of the tobacco industry or their first-degree relatives (parent, child, spouse)