NCT01696006

Brief Summary

The purpose of this study is to determine whether coronary perfusion computed tomography is effective in the treatment of coronary artery disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,059

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

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

First Submitted

Initial submission to the registry

September 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2012

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 22, 2013

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2021

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

7 years

First QC Date

September 26, 2012

Last Update Submit

March 21, 2023

Conditions

Keywords

perfusion computed tomographycoronary artery disease

Outcome Measures

Primary Outcomes (1)

  • Accuracy of coronary perfusion computed tomography

    Positive predictive value Negative predictive value Sensitivity Specificity

    5year

Secondary Outcomes (3)

  • Relationship between coronary perfusion computed tomography and fraction flow reserve

    5year

  • Relationship between coronary perfusion computed tomography and SPECT(nuclear imaging)

    5year

  • occurrence of the event after coronary perfusion computed tomography

    5year

Eligibility Criteria

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

General hospital

You may qualify if:

  • age greater than or equal to 20
  • Patient who has a coronary perfusion computed tomography

You may not qualify if:

  • Unwillingness or inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Asan Medical Center

Seoul, Songpa-Gu, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang, South Korea

Location

Soonchunhyang university hospital

Bucheon-si, South Korea

Location

Dong-A university hospital

Busan, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

The Catholic University of Korea, Daejeon ST. Mary's Hospital

Daejeon, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

ChonBuk National University Hospital

Jeonju, South Korea

Location

Inje university Pusan Paik hospital

Pusan, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Pusan National University Yangsan Hospital

Pusan, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Related Publications (3)

  • Kwon O, Hwang HJ, Koo HJ, Yang DH, Kang HJ, Kim JA, Moon DH, Kim HS, Kang JW, Kim YH. Ischemic burden assessment of myocardial perfusion CT, compared with SPECT using semi-quantitative and quantitative approaches. Int J Cardiol. 2019 Mar 1;278:287-294. doi: 10.1016/j.ijcard.2018.12.046. Epub 2018 Dec 17.

  • Kang SJ, Kweon J, Yang DH, Lee JG, Jung J, Kim N, Mintz GS, Kang JW, Lim TH, Park SW, Kim YH. Mathematically Derived Criteria for Detecting Functionally Significant Stenoses Using Coronary Computed Tomographic Angiography-Based Myocardial Segmentation and Intravascular Ultrasound-Measured Minimal Lumen Area. Am J Cardiol. 2016 Jul 15;118(2):170-6. doi: 10.1016/j.amjcard.2016.04.049. Epub 2016 May 5.

  • Kang SJ, Yang DH, Kweon J, Kim YH, Lee JG, Jung J, Kim N, Mintz GS, Kang JW, Lim TH, Park SW. Better Diagnosis of Functionally Significant Intermediate Sized Narrowings Using Intravascular Ultrasound-Minimal Lumen Area and Coronary Computed Tomographic Angiography-Based Myocardial Segmentation. Am J Cardiol. 2016 Apr 15;117(8):1282-8. doi: 10.1016/j.amjcard.2016.01.022. Epub 2016 Jan 28.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Young-Hak Kim, MD, PhD

Study Record Dates

First Submitted

September 26, 2012

First Posted

September 28, 2012

Study Start

November 22, 2013

Primary Completion

November 25, 2020

Study Completion

January 14, 2021

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations