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

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
Behavioral: Switching to E-cigarette
Switching to E-cigarette
Quitter
quitters after PCI
Behavioral: Smoking cessation
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

Samsung Medical Center

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

Keywords

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.

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