Actively Recruiting
Coronary Artery Calcification in Type 2 Diabetes Mellitus (USCAC Study)
Led by University of South China · Updated on 2021-09-29
1400
Participants Needed
1
Research Sites
500 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Coronary Artery Calcification in Type 2 Diabetes Mellitus (USCAC Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 18 years old
- Diagnosed with type 2 diabetes according to WHO criteria
- Able to undergo low dose dual-source CT coronary angiography at baseline
- Able to understand the study and provide informed consent voluntarily
You will not qualify if you...
- Previous coronary artery stenting or bypass surgery
- Severe lung failure, liver dysfunction (ALT or AST 3 times normal or increased bilirubin), or kidney dysfunction (GFR < 45 ml/min/1.73m2) or on dialysis
- Malignant tumor
- Mental illness or mental retardation
- Pregnant, breastfeeding, or planning pregnancy
- Diseases affecting calcium balance or soft tissue calcification such as hyperparathyroidism, sarcoidosis, or amyloidosis
- Contraindications to contrast agents
- Poor compliance making study completion unlikely by researcher judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of University of South China
Hengyang, China
Actively Recruiting
Research Team
L
Liu Jianghua, PhD
CONTACT
F
Fu Chenxiao, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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