BridgeMD
Compares treatment options for Coronary Artery Disease
Official title Effects of Switching From Cigarettes to Tobacco Heating System on Coronary Atherosclerosis Progression
ClinicalTrials.gov ID: NCT05660798
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Adults aged \>18 years and \<75 years
- people with stable chronic coronary syndrome defined as the presence of at least one coronary artery stenosis \>=20% due to coronary plaque visible...
- 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...
- Current smokers with a minimum of self-reported current smoking pattern of \>10 cigarettes/day during the last 6 months prior to screening, smoking...
- 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...
You likely can't join 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
See the full eligibility criteria
- Adults aged \>18 years and \<75 years
- people 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...
- 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...
- 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
- 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
- people with documented genetic familial hypercholesterolemia
- people have known serious infection or chronic inflammatory systemic disease (e.g. rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis)
- people 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
- people have hypersensitivity or any other warnings listed in the local labeling for THS
- people have hypersensitivity to imaging iodine contrast agents
- GFR\<45 ml/min/1,73 m2
- people who could not participate for any reason other than medical (e.g., psychological and/or social reason) per Investigator's judgment
- people have any other clinical condition that would jeopardize the subject's safety while participating in this study, per Investigator's judgment
- Female subject is pregnant or breast-feeding, or planning to become pregnant during the study
- people have previously participated in this study, or in an treatment study (drug or medical device) within 30 days of screening (participation in observational studies/registries allowed)
- people 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)
- people are current or former employee of the tobacco industry or their first-degree relatives (parent, child, spouse)
The study team makes the final eligibility decision.
Where it's taking place
- Warsaw, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warsaw, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.