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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06338761
Other study ID # E-cigarette PCI
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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