Ignite Creation Date:
2024-05-06 @ 6:27 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05660798
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-12-28
First Post:
2022-10-12
Brief Title:
Effects of Switching From Cigarettes to Tobacco Heating System on Coronary Atherosclerosis Progression
Sponsor:
National Institute of Cardiology Warsaw Poland
Organization:
National Institute of Cardiology Warsaw Poland
Study Overview
Official Title:
Effects of Switching From Cigarettes to Tobacco Heating System on Coronary Atherosclerosis Progression in Patients With Stable Coronary Artery Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SWITCH
Brief Summary:
Objective
To evaluate the impact of heated versus combustion tobacco products on progression of atherosclerosis in patients with CAD unableunwilling 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 HTPIQOS 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 bodys 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 HTPcigarettes
To evaluate the impact of heated versus combustion tobacco products on progression of atherosclerosis in patients with CAD unableunwilling 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 HTPIQOS 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 bodys 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 HTPcigarettes
Detailed Description:
Objective
To evaluate the impact of heated versus combustion tobacco products on progression of atherosclerosis in patients with CAD unableunwilling to quit smoking
Background 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 HTPIQOS 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 bodys 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 HTPcigarettes
Methods
Prospective single-centre open-label randomised study including 180 stable patients with coronary artery disease CAD as diagnosed on CCTA without indications for invasive treatment unableunwilling to quit smoking randomised 11 to either heated group H or combustion group C tobacco products and followed for 18 months The follow-up is accomplished with CCTA scan The study clinical visits are planned at 1 3 6 12 and 18 months
The primary outcome is change in non calcified plaque volume at 18 months between H and C groups intention to treat design
To evaluate the impact of heated versus combustion tobacco products on progression of atherosclerosis in patients with CAD unableunwilling to quit smoking
Background 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 HTPIQOS 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 bodys 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 HTPcigarettes
Methods
Prospective single-centre open-label randomised study including 180 stable patients with coronary artery disease CAD as diagnosed on CCTA without indications for invasive treatment unableunwilling to quit smoking randomised 11 to either heated group H or combustion group C tobacco products and followed for 18 months The follow-up is accomplished with CCTA scan The study clinical visits are planned at 1 3 6 12 and 18 months
The primary outcome is change in non calcified plaque volume at 18 months between H and C groups intention to treat design
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None