Research on the Correlation Among Magnetocardiography Patterns and Known Cardiovascular Risk Factors in Diabetic Patients

Tracking Information
First Submitted Date	October 5, 2009
First Posted Date	October 6, 2009
Last Update Posted Date	August 16, 2010
Study Start Date	October 2009
Primary Completion Date	Not Provided
Current Primary Outcome Measures; (submitted: October 5, 2009)	The smooth index of corrected QT interval (SIQTC) measured by MCG [ Time Frame: as the MCG exam is over ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT00989924 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Research on the Correlation Among Magnetocardiography Patterns and Known Cardiovascular Risk Factors in Diabetic Patients
Official Title	Research on the Correlation Among Magnetocardiography Patterns and Known Cardiovascular Risk Factors in Diabetic Patients
Brief Summary	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 Type	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	The Diabetic patient who receives follow-up at NTUH diabetics caring network
Condition	Diabetes Mellitus
Intervention	Not Provided
Study Groups/Cohorts	Diabetes mellitus; The Diabetic patient who receives follow-up at NTUH diabetics caring network
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Unknown status
Estimated Enrollment; (submitted: October 5, 2009)	1100
Original Estimated Enrollment	Same as current
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria	Inclusion Criteria: Clear consciousness; Met the diagnostic criteria of DM published by the American Diabetes Association in 2009 Exclusion Criteria: not suitable for MCG exam (ex. with pacemaker implantation or indwelling metallic device)
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Taiwan
Removed Location Countries
Administrative Information
NCT Number	NCT00989924
Other Study ID Numbers	200906039R
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Lee-Ming Chuang/professor, National Taiwan University Hospital
Study Sponsor	National Taiwan University Hospital
Collaborators	Not Provided
Investigators	Study Director: Lee-Ming Chuang, MD. Ph.D. National Taiwan University Hospital Principal Investigator: Chau-Chung Wu, MD. Ph.D. National Taiwan University Hospital Principal Investigator: Yi-Der Jiang, MD. National Taiwan University Hospital Principal Investigator: Tien-Jyun Chang, MD. Ph.D. National Taiwan University Hospital Principal Investigator: Chih-Hung Lin, MD. National Taiwan University Hospital, Yun-Lin Branch
PRS Account	National Taiwan University Hospital
Verification Date	July 2010