Heart DiseasesNCT00155467
Establish a CT Images Database of Patients With Congenital Heart Disease
A study testing CT in people with Heart Diseases, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Setup CT images database of congenital heart disease. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Heart Diseases
- What is being tested?
- CT
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 1995to Dec 2010
- Phase
- Interventional
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- congenital heart disease
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Dept. Medical Imaging, NTUH
Taipei, 100
Shyh-Jye Chen, MD, PhD, +886-3123456 ext. 5586, james@ntumc.org
About this study
Setup CT images database of congenital heart disease.
Read the detailed description
Setup CT images database of congenital heart disease.
- Conditions
- Heart Diseases
- Being tested
- CT
- Keywords
- CT, children, congenital
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy
Secondary outcomes (2)
senstivity
specificity
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 startJan 1995
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,000 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shyh-Jye Chen, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155467
- Sponsor's protocol ID
- 9461700815
- Status last verified
- Jan 1995
- First submitted
- 8 Sep 2005
- Last updated
- 20 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establish a CT Images Database of Patients With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT00155467
- Acronym / sponsor ID
- 9461700815
- Conditions
- Heart Diseases
- Keywords
- CT, children, congenital
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 1995
- Study completion
- Dec 2010
- 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.
Setup CT images database of congenital heart disease.
Detailed description
Setup CT images database of congenital heart disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- congenital heart disease
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT | Procedure or surgery | – |
Primary outcome
diagnostic accuracy
2 secondary outcomes
senstivity
specificity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 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.
Shyh-Jye Chen, MD, PhD principal investigator
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?
A study testing CT in people with Heart Diseases, 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 20 Oct 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 Shyh-Jye Chen, MD, PhD (+886-23123456 ext. 5586, james@ntumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic accuracy. 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 20 Oct 2005.