Coronary ArteriosclerosisNCT00155012
Clinical Application of MDCT in Coronary Artery Disease
An observational study of Coronary Arteriosclerosis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
1) Establish normal value for coronary calcium scoring in Taiwan. 2) Find out the relationship of coronary calcium deposition and coronary artery stenosis. Propose a clinical management guideline based on coronary calcium score. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arteriosclerosis
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2004to Aug 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- coronary artery disease admitted for coronary angiography
Who cannot join
- Heart failure, irregular heart rate
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Wen-jeng Lee, M.D.
About this study
Official title: Clinical Application of 16-Detector Row Computed Tomography in Coronary Artery Disease
- Establish normal value for coronary calcium scoring in Taiwan. 2) Find out the relationship of coronary calcium deposition and coronary artery stenosis. Propose a clinical management guideline based on coronary calcium score. 3) Evaluate sensitivity/specificity of coronary CT angiography and the influence of coronary calcium score on coronary CT angiography. 4) Evaluate the clinical application of myocardial enhancement measurement.
Read the detailed description
Computed tomography is evolving as a tool for noninvasive diagnosis of coronary artery disease. Coronary calcium deposition amount is an established independent coronary artery disease risk factor. However, coronary artery stenosis seldom occurred in the same location as calcium deposition. With the advent of 16-detector-row multislice spiral CT, direct visualization of coronary artery is possible. But it remains a great challenge to obtain diagnostic quality image in the beating heart. Small distal vessels may not be adequately visualized. Artifacts from severe calcification or coronary stent may render diagnosis difficult. The clinical implication of coronary calcium score, indication of coronary CT angiography and myocardial enhancement measurement should be further studied. The purposes of this study are: 1) Establish normal value for coronary calcium scoring in Taiwan. 2) Find out the relationship of coronary calcium deposition and coronary artery stenosis. Propose a clinical management guideline based on coronary calcium score. 3) Evaluate sensitivity/specificity of coronary CT angiography and the influence of coronary calcium score on coronary CT angiography. 4) Evaluate the clinical application of myocardial enhancement measurement.
- Conditions
- Coronary Arteriosclerosis
- Medical subject headings
- Coronary Artery Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2004
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Wen-jeng Lee, M.D., Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155012
- Sponsor's protocol ID
- 9361700491
- Other IDs
- NSC-93-2314-B-002-190
- Status last verified
- Apr 2004
- First submitted
- 9 Sep 2005
- Last updated
- 12 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of 16-Detector Row Computed Tomography in Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00155012
- Acronym / sponsor ID
- 9361700491
- Conditions
- Coronary Arteriosclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2004
- Study completion
- Aug 2006
- First posted
- 12 Sep 2005 (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.
- Establish normal value for coronary calcium scoring in Taiwan. 2) Find out the relationship of coronary calcium deposition and coronary artery stenosis. Propose a clinical management guideline based on coronary calcium score. 3) Evaluate sensitivity/specificity of coronary CT angiography and the influence of coronary calcium score on coronary CT angiography. 4) Evaluate the clinical application of myocardial enhancement measurement.
Detailed description
Computed tomography is evolving as a tool for noninvasive diagnosis of coronary artery disease. Coronary calcium deposition amount is an established independent coronary artery disease risk factor. However, coronary artery stenosis seldom occurred in the same location as calcium deposition. With the advent of 16-detector-row multislice spiral CT, direct visualization of coronary artery is possible. But it remains a great challenge to obtain diagnostic quality image in the beating heart. Small distal vessels may not be adequately visualized. Artifacts from severe calcification or coronary stent may render diagnosis difficult. The clinical implication of coronary calcium score, indication of coronary CT angiography and myocardial enhancement measurement should be further studied. The purposes of this study are: 1) Establish normal value for coronary calcium scoring in Taiwan. 2) Find out the relationship of coronary calcium deposition and coronary artery stenosis. Propose a clinical management guideline based on coronary calcium score. 3) Evaluate sensitivity/specificity of coronary CT angiography and the influence of coronary calcium score on coronary CT angiography. 4) Evaluate the clinical application of myocardial enhancement measurement.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- coronary artery disease admitted for coronary angiography
Key exclusion criteria (1 listed)
- Heart failure, irregular heart rate
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2005.
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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.
Wen-jeng Lee, M.D. study director
National Taiwan University Hospital
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 Arteriosclerosis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 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 12 Sep 2005. 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 Taiwan. 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 Wen-jeng Lee, M.D. (88623562604, jacklee@ntumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 12 Sep 2005.