Switching from cigarettes to heated tobacco products and its effects on heart disease
Effects of Switching From Cigarettes to Tobacco Heating System on Coronary Atherosclerosis Progression in Patients With Stable Coronary Artery Disease
This study is testing whether switching from regular cigarettes to heated tobacco products can help people with heart disease reduce the damage to their arteries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | National Institute of Cardiology, Warsaw, Poland Academic / other |
| Locations | 1 site (Warsaw) |
| Trial ID | NCT05660798 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of switching from traditional combustion cigarettes to heated tobacco products on the progression of coronary atherosclerosis in patients with coronary artery disease who are unwilling or unable to quit smoking. The research focuses on patients aged 18 to 75 with stable chronic coronary syndrome and a history of significant smoking. By comparing the effects of heated tobacco products, which produce fewer harmful chemicals, to conventional cigarettes, the study aims to determine if this switch can reduce cardiovascular harm. The study will involve lifestyle interventions and monitor changes in atherosclerosis progression through medical assessments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with stable coronary artery disease who smoke more than 10 cigarettes a day and are unwilling to quit smoking.
Not a fit: Patients who have recently quit smoking or those who do not have coronary artery disease may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer alternative for smokers that may reduce cardiovascular risks associated with traditional smoking.
How similar studies have performed: Previous studies have shown that switching to heated tobacco products can reduce exposure to harmful chemicals, but this specific approach regarding cardiovascular outcomes is novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Warsaw
- National Institute of Cardiology — Warsaw, Poland (Recruiting)
Study contacts
- Study coordinator: Cezary Kepka, ND PhD
- Email: ckepka@ikard.pl
- Phone: +48223434150
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.