Deciphering the Molecular Landscape of Diabetic Cardiovascular Complications Based on Multi-Omics Analysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Incidence of Major Adverse Cardiovascular Events (MACE)
研究概览
简要总结
The goal of this observational study is to learn about the molecular mechanisms underlying cardiovascular complications in individuals with type 2 diabetes (T2DM) and how they differ from healthy individuals. The study will also identify biomarkers and potential therapeutic targets for better managing diabetes-related heart disease.
The main questions it aims to answer are:
- What molecular changes are associated with cardiovascular complications in T2DM patients compared to healthy individuals?
- How do genetic, gene expression, and protein profiles differ between T2DM patients with and without cardiovascular complications? Researchers will compare the molecular profiles of three groups: healthy controls, individuals with T2DM but no cardiovascular complications, and those with T2DM and cardiovascular complications.
Participants will:
- Provide blood samples for genomics, transcriptomics, and proteomics analysis
- Undergo standard clinical tests such as blood pressure, echocardiogram, and ankle-brachial index measurements
- Be followed for 12 to 24 months to track the development of cardiovascular events Participate in follow-up phone interviews to record major cardiovascular events like heart attacks or strokes
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: Patients aged between 20 and 70 years.
- •Coronary Angiography: Patients who have undergone coronary angiography at the Second Xiangya Hospital of Central South University for various reasons.
- •Informed Consent: Patients who have signed the informed consent form and are willing to participate in the collection and analysis of multi-omics data.
- •Medical History and Samples: Patients who can provide complete medical history and biological samples.
排除标准
- •Severe Diseases or Malignancy: Patients with other severe diseases or malignancies that may affect the study.
- •Cognitive or Psychiatric Disorders: Patients with cognitive or psychiatric disorders that would prevent participation or cooperation in the study.
- •Pregnancy or Lactation: Women who are pregnant or breastfeeding.
- •Short Life Expectancy: Patients with a life expectancy of less than 6 months.
- •Inability to Provide Consent: Patients unable or unwilling to provide informed consent.
结局指标
主要结局
Incidence of Major Adverse Cardiovascular Events (MACE)
时间窗: From enrollment to the end of treatment at 12 months and 24 months
Description: To assess the occurrence of major adverse cardiovascular events (MACE), including myocardial infarction, stroke, or heart failure, over the 2-year follow-up period. Time Frame: 12 months and 24 months follow-up. Measurement Method: Clinical assessments through medical records, including hospitalizations, laboratory data, echocardiograms, and imaging techniques (e.g., vascular imaging, ABI, carotid ultrasound).
次要结局
未报告次要终点