Understanding coronary artery calcification in patients with type 2 diabetes
Prospective Cohort Study of Coronary Artery Calcification in Type 2 Diabetes Mellitus (USCAC Study)
University of South China · NCT04889053
This study looks at how coronary artery calcification affects people with type 2 diabetes over eight years to see how it changes and if taking statins helps.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of South China (other) |
| Locations | 1 site (Hengyang) |
| Trial ID | NCT04889053 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a long-term cohort of patients with type 2 diabetes mellitus (T2DM) who have coronary artery calcification (CAC). It involves a baseline survey followed by an 8-year follow-up across multiple hospitals in Hunan Province, China. The study will evaluate the volume and density of CAC using low dose CT coronary angiography and assess the impact of statins on the progression of CAC. The research seeks to clarify the epidemiological characteristics and clinical progression of CAC in T2DM patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with type 2 diabetes according to WHO criteria.
Not a fit: Patients who have undergone coronary artery stenting or bypass grafting, or those with severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management strategies for coronary artery calcification in patients with type 2 diabetes.
How similar studies have performed: While similar studies have explored coronary artery calcification in diabetes, this specific approach focusing on long-term follow-up and the role of miR-32 is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Hengyang
- The First Affiliated Hospital of University of South China — Hengyang, China (RECRUITING)
Study contacts
- Study coordinator: Liu Jianghua, PhD
- Email: jianghua990@126.com
- Phone: （+86）13407340909
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes, Vascular Calcification, Coronary Artery Calcification, Strains, Epidemiology, microRNA, Vascular calcification, microRNA-32