Coronary Artery DiseaseNCT01896674
Knowledge-based Iterative Model Reconstruction at Low-kilovoltage (kV) Cardiac Computed Tomography (CT)
An observational study of Coronary Artery Disease, run by Kumamoto University.
Trial summary
The purpose of this study was to compare FBP-, hybrid IR-, and IMR techniques to assess their role in the identification of coronary artery disease and abnormalities in cardiac structures. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Jan 2013
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We enroll consecutive patients.
Who may be able to join
- A BMI of 27 kg/m2 or less and a coronary calcium score of less than 1,000 Agatston units.
Who cannot join
- BMI exceeded 27 kg/m2
- renal dysfunction (serum creatinine level > 1.5 mg/dl)
- atrial fibrillation
- prior coronary artery bypass grafting
- heart failure (New York Heart Association class III-IV)
About this study
Official title: Value of Knowledge-based Iterative Model Reconstruction at Low-kilovoltage Cardiac 256-slice CT: A Comparison of Filtered Back Projection-, Hybrid-, and Iterative Model Reconstruction
The purpose of this study was to compare FBP-, hybrid IR-, and IMR techniques to assess their role in the identification of coronary artery disease and abnormalities in cardiac structures.
- Conditions
- Coronary Artery Disease
- Keywords
- Computed tomography
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast to noise ratio of coronary arteries
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startMay 2012
- Primary completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Retrospective
- Enrolment
- 21 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
- NCT01896674
- Sponsor's protocol ID
- Kuma1478
- Status last verified
- Jul 2013
- First submitted
- 8 Jul 2013
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Yuki H, Utsunomiya D, Funama Y, Tokuyasu S, Namimoto T, Hirai T, Itatani R, Katahira K, Oshima S, Yamashita Y. Value of knowledge-based iterative model reconstruction in low-kV 256-slice coronary CT angiography. J Cardiovasc Comput Tomogr. 2014 Mar-Apr;8(2):115-23. doi: 10.1016/j.jcct.2013.12.010. Epub 2014 Jan 12.
PubMed 24661824
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Knowledge-based Iterative Model Reconstruction at Low-kilovoltage Cardiac 256-slice CT: A Comparison of Filtered Back Projection-, Hybrid-, and Iterative Model Reconstruction
- ClinicalTrials.gov ID
- NCT01896674
- Acronym / sponsor ID
- Kuma1478
- Conditions
- Coronary Artery Disease
- Keywords
- Computed tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Kumamoto UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2013 (actual)
- First posted
- 11 Jul 2013 (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 was to compare FBP-, hybrid IR-, and IMR techniques to assess their role in the identification of coronary artery disease and abnormalities in cardiac structures.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We enroll consecutive patients.
Key inclusion criteria (1 listed)
- A BMI of 27 kg/m2 or less and a coronary calcium score of less than 1,000 Agatston units.
Key exclusion criteria (5 listed)
- BMI exceeded 27 kg/m2
- renal dysfunction (serum creatinine level > 1.5 mg/dl)
- atrial fibrillation
- prior coronary artery bypass grafting
- heart failure (New York Heart Association class III-IV)
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
Contrast to noise ratio of coronary arteries
Time frame: 6 months
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 11 Jul 2013.
- Derived from this study: PubMed 24661824Yuki H, Utsunomiya D, Funama Y, Tokuyasu S, Namimoto T, Hirai T, Itatani R, Katahira K, Oshima S, Yamashita Y. Value of knowledge-based iterative model reconstruction in low-kV 256-slice coronary CT angiography. J Cardiovasc Comput Tomogr. 2014 Mar-Apr;8(2):115-23. doi: 10.1016/j.jcct.2013.12.010. Epub 2014 Jan 12.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Kumamoto University.
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 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Contrast to noise ratio of coronary arteries (time frame: 6 months). 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 NCT01896674, which also lists 1 linked publication.
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 Jul 2013.