Coronary Artery DiseasePerfusion CTNCT01696006
Perfusion CT Registry
An observational study of Coronary Artery Disease, run by Young-Hak Kim, MD, PhD at 13 sites in South Korea.
Trial summary
The purpose of this study is to determine whether coronary perfusion computed tomography is effective in the treatment of coronary artery disease. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 1,059 participants
- Where
- 13 sitesSouth Korea
- Study dates
- 22 Nov 2013to 14 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General hospital
Who may be able to join
- age greater than or equal to 20
- Patient who has a coronary perfusion computed tomography
Who cannot join
- Unwillingness or inability to give informed consent
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
South Korea13 sites
Hallym University Sacred Heart Hospital
Anyang
Soonchunhyang university hospital
Bucheon-si
Dong-A university hospital
Busan
Kyungpook National University Hospital
Daegu
Chungnam National University Hospital
Daejeon
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon
Chonnam National University Hospital
Gwangju
ChonBuk National University Hospital
Jeonju
Inje university Pusan Paik hospital
Pusan
Pusan National University Hospital
Pusan
Pusan National University Yangsan Hospital
Pusan
Asan Medical Center
Seoul, Songpa-Gu
Ulsan University Hospital
Ulsan
About this study
The purpose of this study is to determine whether coronary perfusion computed tomography is effective in the treatment of coronary artery disease.
- Conditions
- Coronary Artery Disease
- Keywords
- perfusion computed tomography, coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of coronary perfusion computed tomography
Positive predictive value Negative predictive value Sensitivity Specificity
Measured: 5year
Secondary outcomes (3)
Relationship between coronary perfusion computed tomography and fraction flow reserve
Measured: 5year
Relationship between coronary perfusion computed tomography and SPECT(nuclear imaging)
Measured: 5year
occurrence of the event after coronary perfusion computed tomography
Death Myocardial infarction coronary angiography Revascularization
Measured: 5year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study start22 Nov 2013
- Primary completion25 Nov 2020
- Study completion14 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,059 participants (actual)
Sponsor and investigators
- Lead sponsor
- Young-Hak Kim, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Young-Hak Kim, MD, PhD, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696006
- Sponsor's protocol ID
- AMCCV 2012-04
- Acronym
- Perfusion CT
- Status last verified
- Mar 2023
- First submitted
- 26 Sep 2012
- Last updated
- 22 Mar 2023
- Results posted
- No
Publications
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.
PubMed 30587418Kang 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.
PubMed 27236253Kang 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.
PubMed 26892449
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion CT Registry
- ClinicalTrials.gov ID
- NCT01696006
- Acronym / sponsor ID
- Perfusion CT / AMCCV 2012-04
- Conditions
- Coronary Artery Disease
- Keywords
- perfusion computed tomography, coronary artery disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,059 participants (actual)
- Lead sponsor
- Young-Hak Kim, MD, PhDUniversity, hospital or other
- Study start
- 22 Nov 2013 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 28 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether coronary perfusion computed tomography is effective in the treatment of coronary artery disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General hospital
Key inclusion criteria (2 listed)
- age greater than or equal to 20
- Patient who has a coronary perfusion computed tomography
Key exclusion criteria (1 listed)
- Unwillingness or inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of coronary perfusion computed tomography
Time frame: 5year
Positive predictive value Negative predictive value Sensitivity Specificity
3 secondary outcomes
Relationship between coronary perfusion computed tomography and fraction flow reserve
Time frame: 5year
Relationship between coronary perfusion computed tomography and SPECT(nuclear imaging)
Time frame: 5year
occurrence of the event after coronary perfusion computed tomography
Time frame: 5year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Derived from this study: PubMed 30587418Kwon 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.
- Derived from this study: PubMed 27236253Kang 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.
- Derived from this study: PubMed 26892449Kang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Young-Hak Kim, MD, PhD at 13 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of coronary perfusion computed tomography (time frame: 5year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01696006, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.