Coronary Artery Disease, Ischemic Heart DiseaseNCT02099019
Usefulness of Coronary Computed Tomography Angiography for Therapeutic Decision- Making; Revascularization
An observational study of Coronary Artery Disease, Ischemic Heart Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
As the prospective, observational, cross-sectional study, the accuracy of CT angiography-based therapeutic decision-making for revascularization will be evaluated. The primary objective of this study is to evaluate the accuracy of CT angiography-based therapeutic decision-making for revascularization prior to… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease, Ischemic Heart Disease
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Feb 2025
- 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: Patients who visited the tertiary hospital for coronary angiography who are undergone CT angiography prior to conventional coronary agniography
Who may be able to join
- Patients ≥ 20 years old
- Patients who are scheduled for elective conventional coronary angiography and are undergone CT angiography prior to conventional coronary angiography.
Who cannot join
- Pregnant women or women with potential childbearing
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Seoul, 120-752
MYEONG-KI HONG, MD, 82-2-2228-8458, MKHONG61@yuhs.ac
About this study
As the prospective, observational, cross-sectional study, the accuracy of CT angiography-based therapeutic decision-making for revascularization will be evaluated. The primary objective of this study is to evaluate the accuracy of CT angiography-based therapeutic decision-making for revascularization prior to conventional angiography whether CT angiography is an accurate non-invasive technique to determine the most appropriate therapeutic strategies.
- Keywords
- Coronary CT angiography; Revascularization; Decision-making
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of CT angiography
Sensitivity, specificity, positive predictive value, and negative predictive value for revascularization including PCI and CABG.
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease, Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099019
- Sponsor's protocol ID
- 1-2013-0084
- Status last verified
- Jan 2019
- First submitted
- 19 Mar 2014
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Coronary Computed Tomography Angiography for Therapeutic Decision- Making; Revascularization
- ClinicalTrials.gov ID
- NCT02099019
- Acronym / sponsor ID
- 1-2013-0084
- Keywords
- Coronary CT angiography; Revascularization; Decision-making
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 28 Mar 2014 (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.
As the prospective, observational, cross-sectional study, the accuracy of CT angiography-based therapeutic decision-making for revascularization will be evaluated. The primary objective of this study is to evaluate the accuracy of CT angiography-based therapeutic decision-making for revascularization prior to conventional angiography whether CT angiography is an accurate non-invasive technique to determine the most appropriate therapeutic strategies.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visited the tertiary hospital for coronary angiography who are undergone CT angiography prior to conventional coronary agniography
Key inclusion criteria (2 listed)
- Patients ≥ 20 years old
- Patients who are scheduled for elective conventional coronary angiography and are undergone CT angiography prior to conventional coronary angiography.
Key exclusion criteria (1 listed)
- Pregnant women or women with potential childbearing
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 CT angiography
Time frame: 1day
Sensitivity, specificity, positive predictive value, and negative predictive value for revascularization including PCI and CABG.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
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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.
1 site 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, Ischemic Heart Disease, run by Yonsei University at 1 site 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: status not confirmed, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myeong-Ki Hong, MD, PhD (082 2 2228 8458 ext. 88458, mkhong61@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of CT angiography (time frame: 1day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2019.