Switching to E-cigarette After PCI

Coronary Artery Disease Clinical Trial

— E-cig-PCI  

Official title:

Prognostic Impact of Switching to E-Cigarette Use in Smokers With Coronary Artery Disease Following Percutaneous Coronary Intervention: A Nationwide Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06338761
• Other study ID #: E-cigarette PCI
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Samsung Medical Center
• Contact: Ki Hong Choi
• Phone: 82-2-3410-3419
• Email: cardiokh[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Despite the increasing popularity of electronic cigarettes (E-cigarettes), the prognostic impact of switching to E-cigarettes in smokers with coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI) remains uncertain.

Description:

Recently, several studies have reported that, although lower than combustible cigarette users, E-cigarette users had a significantly higher risk of future myocardial infarction (MI) or cardiovascular disease compared with non-smokers or quitters. However, because all previous studies has focused on the general healthy population, these results cannot be extrapolated for patients who already proven atherosclerotic cardiovascular disease (ASCVD), such as undergoing percutaneous coronary intervention (PCI) for coronary artery disease (CAD). Although Busch et al. previously reported that a significant minority of patients are using E-cigarettes post-acute coronary syndrome smokers, a paucity of data exists regarding the impact of such transitions on clinical outcomes in current smoker patients with CAD who have undergone PCI. In light of these considerations, the current study sought to address this gap in knowledge by evaluating the prognostic implications of smoking habit changes, including E-cigarette use, among CAD patients with current smoking status following PCI.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 17442
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• patients who underwent health screening 3 years before and after the PCI

Exclusion Criteria:

• history of cancer

• history of ischemic stroke

• died within the first 3 months of follow-up from the index date

• Newly developed acute MI or received additional PCI or CABG from the index PCI date to the study index date

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Behavioral:
• Smoking cessation
Stop smoking
• Switching to E-cigarette
Switching to E-cigarette

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE	Major adverse cardiac event	5 years after PCI
Secondary	Cardiovascular death	death from cardiovascular cause	5 years after PCI
Secondary	All-cause death	death from any cause	5 years after PCI
Secondary	Spontaneous myocardial infarction	MI with hospitalization	5 years after PCI
Secondary	Repeat revascularization	additional PCI or CABG	5 years after PCI