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

Recruiting now

Conditions studied: Type 2 Diabetes, Vascular Calcification, Coronary Artery Calcification, Strains, Epidemiology, microRNA

In brief

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.

Key facts

Study ID

NCT04889053

Run by

University of South China

People needed

1400

Starts

2021-06-01

Expected to finish

2030-12-31

Last updated by the study team

2021-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Those have received coronary artery stenting or coronary artery bypass grafting
• Those with severe lung (respiratory failure), liver (ALT or AST 3 times normal value or bilirubin increase), renal dysfunction[GFR < 45ml/(min.1.73m2) or dialysis patients
• Malignant tumor
• Mental illness or mental retardation
• Pregnant or lactating women or those with fertility planning
• Concomitant diseases (hyperparathyroidism, sarcoidosis, amyloidosis) affecting calcium balance and soft tissue calcification
• Contraindications of contrast agents
• Based on the judgment of the researcher, the compliance is poor and the study could not be completed according to the requirements

Where it is running

• The First Affiliated Hospital of University of South China — Hengyang, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.