Coronary Artery DiseaseE-cig-PCINCT06338761
Switching to E-cigarette After PCI
An observational study of Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Smoking cessation and Switching to E-cigarette
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 17,973 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2024to 15 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with coronary artery disease who underwent health screening 3 years before and after the PCI
Who may be able to join
- patients who underwent health screening 3 years before and after the PCI
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Smoking cessation, Switching to E-cigarette
- Keywords
- Percutaneous coronary intervention, E-cigarette, Smoking
- Medical subject headings
- Coronary Artery Disease, Vaping, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessationBehavioural
Stop smoking
Switching to E-cigaretteBehavioural
Switching to E-cigarette
| Study group | Role | What they receive |
|---|---|---|
| Continued combustible cigarette use | continued combustible cigarettes users after PCI | |
| Switching to E-cigarette | switching to E-cigarette users after PCI Receives: Behavioral: Switching to E-cigarette | |
| Quitter | quitters after PCI Receives: Behavioral: Smoking cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
Major adverse cardiac event
Measured: 5 years after PCI
Secondary outcomes (4)
Cardiovascular death
death from cardiovascular cause
Measured: 5 years after PCI
All-cause death
death from any cause
Measured: 5 years after PCI
Spontaneous myocardial infarction
MI with hospitalization
Measured: 5 years after PCI
Repeat revascularization
additional PCI or CABG
Measured: 5 years after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 17,973 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Hong Choi, Samsung Medical Center
- Investigators
- Ki Hong Choi, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338761
- Sponsor's protocol ID
- E-cigarette PCI
- Acronym
- E-cig-PCI
- Status last verified
- May 2025
- First submitted
- 24 Mar 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kang D, Choi KH, Kim H, Park H, Heo J, Park TK, Lee JM, Cho J, Yang JH, Hahn JY, Choi SH, Gwon HC, Song YB. Prognosis after switching to electronic cigarettes following percutaneous coronary intervention: a Korean nationwide study. Eur Heart J. 2025 Jan 3;46(1):84-95. doi: 10.1093/eurheartj/ehae705.
PubMed 39429032
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of Switching to E-Cigarette Use in Smokers With Coronary Artery Disease Following Percutaneous Coronary Intervention: A Nationwide Cohort Study
- ClinicalTrials.gov ID
- NCT06338761
- Acronym / sponsor ID
- E-cig-PCI / E-cigarette PCI
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous coronary intervention, E-cigarette, Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,973 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continued combustible cigarette use | – | –continued combustible cigarettes users after PCI |
| Switching to E-cigarette | – | Behavioral: Switching to E-cigaretteswitching to E-cigarette users after PCI |
| Quitter | – | Behavioral: Smoking cessationquitters after PCI |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with coronary artery disease who underwent health screening 3 years before and after the PCI
Key inclusion criteria (1 listed)
- patients who underwent health screening 3 years before and after the PCI
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessationStop smoking | Behavioural | Quitter |
| Switching to E-cigaretteSwitching to E-cigarette | Behavioural | Switching to E-cigarette |
Primary outcome
MACE
Time frame: 5 years after PCI
Major adverse cardiac event
4 secondary outcomes
Cardiovascular death
Time frame: 5 years after PCI
All-cause death
Time frame: 5 years after PCI
Spontaneous myocardial infarction
Time frame: 5 years after PCI
Repeat revascularization
Time frame: 5 years after PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Derived from this study: PubMed 39429032Kang D, Choi KH, Kim H, Park H, Heo J, Park TK, Lee JM, Cho J, Yang JH, Hahn JY, Choi SH, Gwon HC, Song YB. Prognosis after switching to electronic cigarettes following percutaneous coronary intervention: a Korean nationwide study. Eur Heart J. 2025 Jan 3;46(1):84-95. doi: 10.1093/eurheartj/ehae705.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki Hong Choi, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 5 years after PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06338761, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.