NCT03298282

Brief Summary

The coronary images of selective angiography and optical coherence tomography with FFR(Fractional Flow Reserve) values of the intermediate lesions (40-70% stenosis) will be prospectively registered.

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
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

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

First Submitted

Initial submission to the registry

September 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

October 10, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

3.9 years

First QC Date

September 26, 2017

Last Update Submit

October 11, 2020

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (8)

  • Change of plaque on coronary CTA for during 2 years

    at registration

  • Change of plaque on coronary CTA for during 2 years

    at 2-year follow up

  • Change of plaque on coronary OCT for during 2 years

    at registration

  • Change of plaque on coronary OCT for during 2 years

    at 2-year follow up

  • Change of FFR value during 2 years

    at registration

  • Change of FFR value during 2 years

    at 2-year follow up

  • Comparison of computational FFR derived from OCT to invasive FFR

    at registration

  • Comparison of computational FFR derived from OCT to invasive FFR

    at 2-year follow up

Secondary Outcomes (3)

  • Adverse event for 2 years (myocardial infarction, cardiovascular death)

    within 2 years after registration

  • Power of plaque characteristics on coronary CTA for predicting adverse events

    within 2 years after registration

  • Power of plaque characteristics on OCT for predicting adverse events

    within 2 years after registration

Study Arms (1)

Imaging Registry

Imaging cohort: Patients with intermediate lesions

Other: OCT (Optical Coherence Tomography)Other: Coronary CTAOther: FFR

Interventions

OCT (Optical Coherence Tomography)OTHER

Coronary images by OCT and selective CTA and FFR values will be registered.

Imaging Registry
Coronary CTAOTHER

Coronary images by OCT and Coronary CTA and FFR values will be registered.

Imaging Registry
FFROTHER

Coronary images by OCT and selective CTA and FFR values will be registered.

Imaging Registry

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Tertiary cardiovascular hospital

You may qualify if:

  • Patients who underwent coronary CT angiography because of chest pain
  • Patients who need OCT or FFR evaluation because of intermediate lesions according to invasive angiography (diameter stenosis of 40-70%)
  • Age: 20-80 yrs
  • Patients who consent and fully understand the protocol
  • Patients who consent the clinical follow-up
  • Patients who can be followed-up

You may not qualify if:

  • Patients who had contrast allergy
  • Patients who had unstable blood pressure needing the vasopressors
  • Patients who had severe left ventricular function (left ventricular ejection fraction\<30%)
  • Chronic kidney disease who had Cr level of greater than 2.0 mg/dl
  • Patients whose expected survival is less than 12 months
  • Patients who had a severe valvular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Cardiovascular Hospital, Yonsei University

Seoul, 03722, South Korea

Location

Related Publications (1)

  • Lee YJ, Kim YW, Ha J, Kim M, Guagliumi G, Granada JF, Lee SG, Lee JJ, Cho YK, Yoon HJ, Lee JH, Kim U, Jang JY, Oh SJ, Lee SJ, Hong SJ, Ahn CM, Kim BK, Chang HJ, Ko YG, Choi D, Hong MK, Jang Y, Lee JS, Kim JS. Computational Fractional Flow Reserve From Coronary Computed Tomography Angiography-Optical Coherence Tomography Fusion Images in Assessing Functionally Significant Coronary Stenosis. Front Cardiovasc Med. 2022 Jun 13;9:925414. doi: 10.3389/fcvm.2022.925414. eCollection 2022.

    PMID: 35770218DERIVED

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

  • Jung-Sun Kim, PhD

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2017

First Posted

October 2, 2017

Study Start

October 10, 2017

Primary Completion

September 1, 2021

Study Completion

September 30, 2021

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)