Switching to E-cigarette After PCI (E-cig-PCI)
May 17, 2025 updated by: Ki Hong Choi, Samsung Medical Center
Prognostic Impact of Switching to E-Cigarette Use in Smokers With Coronary Artery Disease Following Percutaneous Coronary Intervention: A Nationwide Cohort Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
17973
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Samsung Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patients with coronary artery disease who underwent health screening 3 years before and after the PCI
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Continued combustible cigarette use
continued combustible cigarettes users after PCI
|
|
|
Switching to E-cigarette
switching to E-cigarette users after PCI
|
Switching to E-cigarette
|
|
Quitter
quitters after PCI
|
Stop smoking
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MACE
Time Frame: 5 years after PCI
|
Major adverse cardiac event
|
5 years after PCI
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiovascular death
Time Frame: 5 years after PCI
|
death from cardiovascular cause
|
5 years after PCI
|
|
All-cause death
Time Frame: 5 years after PCI
|
death from any cause
|
5 years after PCI
|
|
Spontaneous myocardial infarction
Time Frame: 5 years after PCI
|
MI with hospitalization
|
5 years after PCI
|
|
Repeat revascularization
Time Frame: 5 years after PCI
|
additional PCI or CABG
|
5 years after PCI
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ki Hong Choi, MD, Samsung Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Actual)
December 31, 2024
Study Completion (Actual)
March 15, 2025
Study Registration Dates
First Submitted
March 24, 2024
First Submitted That Met QC Criteria
March 24, 2024
First Posted (Actual)
April 1, 2024
Study Record Updates
Last Update Posted (Actual)
May 21, 2025
Last Update Submitted That Met QC Criteria
May 17, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-cigarette PCI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.