NCT06338761

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17,973

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

1 year

First QC Date

March 24, 2024

Last Update Submit

May 17, 2025

Conditions

Coronary Artery Disease

Keywords

Percutaneous coronary interventionE-cigaretteSmoking

Outcome Measures

Primary Outcomes (1)

  • MACE

    Major adverse cardiac event

    5 years after PCI

Secondary Outcomes (4)

  • Cardiovascular death

    5 years after PCI

  • All-cause death

    5 years after PCI

  • Spontaneous myocardial infarction

    5 years after PCI

  • Repeat revascularization

    5 years after PCI

Study Arms (3)

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

Quitter

quitters after PCI

Behavioral: Smoking cessation

Interventions

Smoking cessationBEHAVIORAL

Stop smoking

Quitter
Switching to E-cigaretteBEHAVIORAL

Switching to E-cigarette

Switching to E-cigarette

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with coronary artery disease who underwent health screening 3 years before and after the PCI

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 39429032DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseVapingSmoking

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesBehavior

Study Officials

  • Ki Hong Choi, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 24, 2024

First Posted

April 1, 2024

Study Start

January 1, 2024

Primary Completion

December 31, 2024

Study Completion

March 15, 2025

Last Updated

May 21, 2025

Record last verified: 2025-05

Locations

KR(1)