Coronary Artery DiseaseTDINCT01092429
2D and Tissue Doppler Imaging Echocardiography Analysis of Left Ventricular Regional Wall Motion and Prognosis
An observational study of Coronary Artery Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Development of myocardial ischemia, and/or myocarditis would induce different changes in myocardial contraction behavior pattern,which maybe very subtle, and may not be detected by the 2D and m-mode echocardiography examinations. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2008to Dec 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Accoring to recommendation of ACC/AHA, patient had classI indication to perform coronary angiography
Who may be able to join
- Angina
- Acue coronary syndrome
- Left ventricular systolic dysfunction
Who cannot join
- Significant valvular disease
- Active cancer status
- Acute Renal failure
- Contrast allergy history
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Fun-Chung Lin, MD contact
Taiwan1 site, 1 recruiting
- Recruiting
Cheng Gung Memorial Hospital at Linkou
Taipei
Tsang-Tang Hsieh, MD, +886 -3-3196200 ext. 3656, tth3388@adm.cgmh.org.tw
About this study
Development of myocardial ischemia, and/or myocarditis would induce different changes in myocardial contraction behavior pattern,which maybe very subtle, and may not be detected by the 2D and m-mode echocardiography examinations. According to tissue Doppler imaging(TDI), they can be depicted by different models of echo with higher frame rates. In addition, many studies using TDI have significantly contributed of efforts to evaluate systolic and diastolic function and prognosis.
This study assess the value of the indices of left ventricular function obtained by using TDI in patient with coronary artery disease(CAD). We hypothesized that TDI will add incremental value for regional wall motion abnormality of CAD and its prognosis.
- Conditions
- Coronary Artery Disease
- Keywords
- CAD
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| one,two,and three vessels disease; mortality | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
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 posted25 Mar 2010 (estimated)
- Study startFeb 2008
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
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.
- More trials run by Chang Gung Memorial 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092429
- Sponsor's protocol ID
- 96-1504B
- Acronym
- TDI
- Status last verified
- Jun 2011
- First submitted
- 23 Mar 2010
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2D and Tissue Doppler Imaging Echocardiography Analysis of Left Ventricular Regional Wall Motion and Prognosis
- ClinicalTrials.gov ID
- NCT01092429
- Acronym / sponsor ID
- TDI / 96-1504B
- Conditions
- Coronary Artery Disease
- Keywords
- CAD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Mar 2010 (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.
Development of myocardial ischemia, and/or myocarditis would induce different changes in myocardial contraction behavior pattern,which maybe very subtle, and may not be detected by the 2D and m-mode echocardiography examinations. According to tissue Doppler imaging(TDI), they can be depicted by different models of echo with higher frame rates. In addition, many studies using TDI have significantly contributed of efforts to evaluate systolic and diastolic function and prognosis.
This study assess the value of the indices of left ventricular function obtained by using TDI in patient with coronary artery disease(CAD). We hypothesized that TDI will add incremental value for regional wall motion abnormality of CAD and its prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one,two,and three vessels disease; mortality | – | – |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Accoring to recommendation of ACC/AHA, patient had classI indication to perform coronary angiography
Key inclusion criteria (3 listed)
- Angina
- Acue coronary syndrome
- Left ventricular systolic dysfunction
Key exclusion criteria (5 listed)
- Significant valvular disease
- Active cancer status
- Acute Renal failure
- Contrast allergy history
- Pregnancy
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
all cause mortality
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
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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.
Fun-Chung Lin, MD contact
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, run by Chang Gung Memorial 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 3 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: status not confirmed, as of the sponsor's last update on 29 Jul 2014. 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 Fun-Chung Lin, MD (linfungchung@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (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 29 Jul 2014.