Diabetes MellitusNCT00989924
Research on the Correlation Among Magnetocardiography Patterns and Known Cardiovascular Risk Factors in Diabetic Patients
An observational study of Diabetes Mellitus, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the correlation among magnetocardiography (MCG) patterns and various known cardiovascular risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 1,100 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2009to not given
- 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
Study population: The Diabetic patient who receives follow-up at NTUH diabetics caring network
Who may be able to join
- Clear consciousness
- Met the diagnostic criteria of DM published by the American Diabetes Association in 2009
Who cannot join
- not suitable for MCG exam (ex. with pacemaker implantation or indwelling metallic device)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Lee-Ming Chuang, MD. Ph.D., 886-2-23123456 ext. 65038, leeming@ntu.edu.tw
Lee-Ming Chuang, MD. Ph.D.
About this study
The purpose of this study is to evaluate the correlation among magnetocardiography (MCG) patterns and various known cardiovascular risk factors.
Read the detailed description
It is well understood that diabetes mellitus (DM) causes various micro- and macrovascular complications. Among them, coronary heart diseases (CHDs) claim most mortality, and diabetes has been considered as "CHD equivalent". Furthermore, the risk of CHD has been noticed to increase in the pre-diabetic stage, suggesting the development of CHD may start in a rather early stage of the disease. Thus, early detection of CHD in diabetic patients seems to be important. However, currently exam methods for CHD in diabetic patients seemed to have their limitations.
Developed in the 1960s, magnetocardiography (MCG) is designed to detect the weak magnetic field generated by the electrical activity of the heart, and has been used widely in the study of fetal cardiac electrophysiology, arrhythmia and ischemic heart disease. However, the MCG pattern in diabetic patients is not fully understood. The aim of the study is to clarify the correlation among various cardiovascular risk factors and MCG pattern in diabetic patients. And, according to the results of the study, we'll evaluate the potentiality of MCG in early diagnosis of CHD in diabetic patients.
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes mellitus, Coronary heart disease, Magnetocardiography
- Medical subject headings
- Diabetes Mellitus, Coronary 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 |
|---|---|---|
| Diabetes mellitus | The Diabetic patient who receives follow-up at NTUH diabetics caring network |
What is being measured
The primary outcome is the main question the study is designed to answer.
The smooth index of corrected QT interval (SIQTC) measured by MCG
Measured: as the MCG exam is over
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study startOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lee-Ming Chuang, MD. Ph.D., Study director, National Taiwan University HospitalChau-Chung Wu, MD. Ph.D., Principal investigator, National Taiwan University HospitalYi-Der Jiang, MD., Principal investigator, National Taiwan University HospitalTien-Jyun Chang, MD. Ph.D., Principal investigator, National Taiwan University HospitalChih-Hung Lin, MD., Principal investigator, National Taiwan University Hospital, Yun-Lin Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989924
- Sponsor's protocol ID
- 200906039R
- Status last verified
- Jul 2010
- First submitted
- 5 Oct 2009
- Last updated
- 16 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Correlation Among Magnetocardiography Patterns and Known Cardiovascular Risk Factors in Diabetic Patients
- ClinicalTrials.gov ID
- NCT00989924
- Acronym / sponsor ID
- 200906039R
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes mellitus, Coronary heart disease, Magnetocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2009
- First posted
- 6 Oct 2009 (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 is to evaluate the correlation among magnetocardiography (MCG) patterns and various known cardiovascular risk factors.
Detailed description
It is well understood that diabetes mellitus (DM) causes various micro- and macrovascular complications. Among them, coronary heart diseases (CHDs) claim most mortality, and diabetes has been considered as "CHD equivalent". Furthermore, the risk of CHD has been noticed to increase in the pre-diabetic stage, suggesting the development of CHD may start in a rather early stage of the disease. Thus, early detection of CHD in diabetic patients seems to be important. However, currently exam methods for CHD in diabetic patients seemed to have their limitations.
Developed in the 1960s, magnetocardiography (MCG) is designed to detect the weak magnetic field generated by the electrical activity of the heart, and has been used widely in the study of fetal cardiac electrophysiology, arrhythmia and ischemic heart disease. However, the MCG pattern in diabetic patients is not fully understood. The aim of the study is to clarify the correlation among various cardiovascular risk factors and MCG pattern in diabetic patients. And, according to the results of the study, we'll evaluate the potentiality of MCG in early diagnosis of CHD in diabetic patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes mellitus | – | –The Diabetic patient who receives follow-up at NTUH diabetics caring network |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Diabetic patient who receives follow-up at NTUH diabetics caring network
Key inclusion criteria (2 listed)
- Clear consciousness
- Met the diagnostic criteria of DM published by the American Diabetes Association in 2009
Key exclusion criteria (1 listed)
- not suitable for MCG exam (ex. with pacemaker implantation or indwelling metallic device)
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
The smooth index of corrected QT interval (SIQTC) measured by MCG
Time frame: as the MCG exam is over
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2010.
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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.
Lee-Ming Chuang, MD. Ph.D. study director
National Taiwan University Hospital
Chau-Chung Wu, MD. Ph.D. principal investigator
National Taiwan University Hospital
Yi-Der Jiang, MD. 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?
An observational study of Diabetes Mellitus, 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 2 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 16 Aug 2010. 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 Lee-Ming Chuang, MD. Ph.D. (886-2-23123456 ext. 65038, leeming@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The smooth index of corrected QT interval (SIQTC) measured by MCG (time frame: as the MCG exam is over). 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 16 Aug 2010.