NCT02966262

Brief Summary

All comer registry who had undergone intravascular optical coherence tomography during and/or after coronary intervention.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

3.7 years

First QC Date

April 25, 2016

Last Update Submit

November 14, 2016

Conditions

Coronary Artery DiseaseOptical Coherence Tomography

Outcome Measures

Primary Outcomes (1)

  • Incidence of participants with Major Adverse Cardiovascular Events (MACE)

    Composite of non-fatal myocardial infarction, all cause death, target vessel revascularization

    Up to 10 years

Study Arms (1)

Optical Coherence Tomography registry group

Patients who had undergone optical coherence tomography within coronary intervention

Device: Optical coherence tomography

Interventions

Optical coherence tomographyDEVICE

Intracoronary imaging device which can precisely observe intracoronary structures

Optical Coherence Tomography registry group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All comer registry with patients who had undergone coronary intervention and optical coherence tomography

You may qualify if:

  • patients who had undergone coronary intervention and optical coherence tomography

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, 136-705, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Do-Sun Lim, MD, PhD

    Korea University Anam Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheol Woong Yu, MD, PhD

CONTACT

8229205445ycw717@naver.com

Jae Young Cho, MD

CONTACT

8229205445librato46@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 25, 2016

First Posted

November 17, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2021

Last Updated

November 17, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)