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NCT04889053Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 29 Sept 2021 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1400 (estimated)
First submitted
11 May 2021
Start date
Jun 2021
Primary completion date
Dec 2026
Lead sponsor
University of South China
NCT number
NCT04889053

What you commit to

  • Study type: Observational
  • Planned participants: 1400
  • From Jun 2021 to the primary completion date, Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Those have received coronary artery stenting or coronary artery bypass grafting

Other illness

  • Malignant tumor
  • Mental illness or mental retardation

Lab values

  • 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
  • Concomitant diseases (hyperparathyroidism, sarcoidosis, amyloidosis) affecting calcium balance and soft tissue calcification

Other

  • Pregnant or lactating women or those with fertility planning
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of University of South China
Coordinator of this site? Confirm its status
HengyangChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.