Integrated Coronary Multicenter Imaging Registry

October 11, 2020 updated by: Yonsei University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The patients with intermediate lesions after CT angiography and invasive coronary angiography will be screened, and optical coherence tomography, FFR and selective CT angiography will be performed. The coronary images and FFR values will be registered, and the patients will be followed-up up to 2 years to investigate the adverse clinical events.

Study Type

Observational

Enrollment (Anticipated)

180

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Division of Cardiology, Cardiovascular Hospital, Yonsei University

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Tertiary cardiovascular hospital

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Imaging Registry
Imaging cohort: Patients with intermediate lesions
Other: OCT (Optical Coherence Tomography)
Coronary images by OCT and selective CTA and FFR values will be registered.
Other: Coronary CTA
Coronary images by OCT and Coronary CTA and FFR values will be registered.
Other: FFR
Coronary images by OCT and selective CTA and FFR values will be registered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of plaque on coronary CTA for during 2 years
Time Frame: at registration
at registration
Change of plaque on coronary CTA for during 2 years
Time Frame: at 2-year follow up
at 2-year follow up
Change of plaque on coronary OCT for during 2 years
Time Frame: at registration
at registration
Change of plaque on coronary OCT for during 2 years
Time Frame: at 2-year follow up
at 2-year follow up
Change of FFR value during 2 years
Time Frame: at registration
at registration
Change of FFR value during 2 years
Time Frame: at 2-year follow up
at 2-year follow up
Comparison of computational FFR derived from OCT to invasive FFR
Time Frame: at registration
at registration
Comparison of computational FFR derived from OCT to invasive FFR
Time Frame: at 2-year follow up
at 2-year follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse event for 2 years (myocardial infarction, cardiovascular death)
Time Frame: within 2 years after registration
within 2 years after registration
Power of plaque characteristics on coronary CTA for predicting adverse events
Time Frame: within 2 years after registration
within 2 years after registration
Power of plaque characteristics on OCT for predicting adverse events
Time Frame: within 2 years after registration
within 2 years after registration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Jung-Sun Kim, PhD, Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 10, 2017

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

September 26, 2017

First Submitted That Met QC Criteria

September 28, 2017

First Posted (Actual)

October 2, 2017

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 11, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2017-0049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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