Prospective Cohort Study of Coronary Artery Calcification in Type 2 Diabetes Mellitus (USCAC Study)

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Coronary artery calcification (CAC) is a common complication of type 2 diabetes mellitus(T2DM), which can significantly increase all-cause mortality and the incidence of serious cardiovascular events, and increase the burden of the national economy. The epidemiological characteristics and the clinical progress of CAC are still not clear. Moreover, the pathogenesis of CAC has not yet been fully elucidated, and lack of specific diagnostic indicators. Arterial calcification is an active, reversible, and multifactorial biological process like bone formation. It is generally believed that early detection of calcification lesions and active targeted treatment may be the key to prevention and treatment of vascular calcification. In addition, statins are commonly used in patients with dyslipidemia and can stabilize CAC plaque. However, the timing, dosage and effect of statins are controversial. Moreover, our previous study found that the expression of miR-32 is significantly elevated in patients with CAC, and can promoting vascular calcification. Herein, this study is to conduct a prospective cohort study on T2DM patients with CAC in Hunan province through a multidisciplinary and multi-center cooperation model, the main research objectives include the following three parts: ① To identify the prevalence, incidence, and characteristics of CAC in T2DM patients in Hunan province, and to build a risk assessment model. ② To observe the effects of statins on the occurrence and development of CAC in patients with T2DM, and to provide clinical data for the improvement of medication guidelines; ③To observe the dynamic changes of serum miR-32 in the progression of CAC in patients with T2DM, and to explore its possibility as a serological diagnosis or prognostic bio-maker of CAC. The completion of this research project is expected to bring a new breakthrough in the field of early diagnosis, prognosis evaluation, and intervention treatment of patients with T2DM combined with CAC, and provide an important reference for the formulation of cardiovascular disease prevention and control strategy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years old

• Type 2 diabetes is diagnosed according to WHO diagnostic criteria

• Low dose prospectively triggered sequential dual-source CT coronary angiography can be performed at baseline investigation

• Those subjects are able to understand the purpose and procedure of this study and sign the informed consent voluntarily

Locations
Other Locations
China
The First Affiliated Hospital of University of South China
RECRUITING
Hengyang
Contact Information
Primary
Liu Jianghua, PhD
jianghua990@126.com
(+86)13407340909
Backup
Fu Chenxiao, PhD
nhfyllwyh@163.com
(+86)13469116604
Time Frame
Start Date: 2021-06-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 1400
Treatments
D2M, Vascular calcification-free
Meet the inclusion criteria, there is no calcification detected by low dose prospectively triggered sequential dual-source CT coronary angiography
D2M with vascular calcification
Meet the inclusion criteria, and have coronary artery calcification ( be confirmed by low dose prospectively triggered sequential dual-source CT coronary angiography)
Related Therapeutic Areas
Sponsors
Leads: University of South China

This content was sourced from clinicaltrials.gov

Similar Clinical Trials