Coronary Artery DiseaseNCT02033837
Evaluation of Cardiac CT Appropriateness at Second-generation 320-row CT
An observational study of Coronary Artery Disease and Cardiac CT, run by Kumamoto University at 1 site in Japan.
Trial summary
The influence of the second-generation 320-row area-detector CT (ADCT) on the clinical indications and appropriateness of cardiac CT has not been adequately investigated. The purpose of the survey is to assess the distribution of appropriateness ratings and test outcomes of cardiac CT with second-generation ADCT. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Coronary Artery Disease, Cardiac CT
- How many people
- 309 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2013to Aug 2017
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients referred for coronary CT angiography at our hospital
Who may be able to join
- indicated for coronary CT assessment
Who cannot join
- aortic disease
- pulmonary embolism
- severe arrhythmia
- severe heart failure
- allergy for iodinated contrast agent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Cardiac CT Appropriateness at Second-generation 320-row CT With 0.275-sec Gantry Rotation Speed
The influence of the second-generation 320-row area-detector CT (ADCT) on the clinical indications and appropriateness of cardiac CT has not been adequately investigated. The purpose of the survey is to assess the distribution of appropriateness ratings and test outcomes of cardiac CT with second-generation ADCT.
- Conditions
- Coronary Artery Disease, Cardiac CT
- Keywords
- Coronary artery disease, Cardiac CT, Appropriate Use Criteria (AUC)
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
significant coronary stenosis
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startJan 2013
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cross-sectional
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kumamoto University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daisuke Utsunomiya, Kumamoto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033837
- Sponsor's protocol ID
- Kuma1594
- Status last verified
- Aug 2017
- First submitted
- 9 Jan 2014
- Last updated
- 22 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiac CT Appropriateness at Second-generation 320-row CT With 0.275-sec Gantry Rotation Speed
- ClinicalTrials.gov ID
- NCT02033837
- Acronym / sponsor ID
- Kuma1594
- Conditions
- Coronary Artery Disease, Cardiac CT
- Keywords
- Coronary artery disease, Cardiac CT, Appropriate Use Criteria (AUC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Kumamoto UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 13 Jan 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.
The influence of the second-generation 320-row area-detector CT (ADCT) on the clinical indications and appropriateness of cardiac CT has not been adequately investigated. The purpose of the survey is to assess the distribution of appropriateness ratings and test outcomes of cardiac CT with second-generation ADCT.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients referred for coronary CT angiography at our hospital
Key inclusion criteria (1 listed)
- indicated for coronary CT assessment
Key exclusion criteria (5 listed)
- aortic disease
- pulmonary embolism
- severe arrhythmia
- severe heart failure
- allergy for iodinated contrast agent
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
significant coronary stenosis
Time frame: one year
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 Aug 2017.
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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.
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 and Cardiac CT, run by Kumamoto University at 1 site in Japan.
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 1 inclusion and 5 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 Aug 2017. 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 Japan. 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?
significant coronary stenosis (time frame: one year). 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 22 Aug 2017.