Evaluating Atherosclerotic Disease Progression in High-Risk Patients With Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- progression of total coronary plaque volume (mm3)
研究概览
简要总结
People with type 2 diabetes have a much higher risk of heart disease. One common problem is when the blood vessels that supply the heart become narrowed or blocked by fatty deposits, called plaque. This makes it harder for blood to reach the heart and can lead to serious problems such as chest pain, heart attacks, or even death.
This study will follow people with type 2 diabetes who have already had a special heart scan called a coronary CT angiography. This scan takes detailed pictures of the heart's blood vessels.
The goal is to understand how heart disease changes over time in people with type 2 diabetes, by looking at repeat scans and other health information. By learning more about how plaque builds up or gets worse, researchers hope to find better ways to identify which patients are most at risk for future heart problems.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •Previous completion of CCTA scan for CAD assessment
- •Diagnosed with Type 2 Diabetes and currently receiving glucose lowering treatment
- •Sufficient image quality of the CCTA scan (at least 2/3 vessels of sufficient quality for assessment).
排除标准
- •Inability to provide written informed consent
- •Presence of an unstable condition
- •Ingeligibility for CCTA acquisition due to severe renal dysfunction (eGFR ≤ 30 mL/min/1.73m²) or known hypersensitivity or contraindication to CT contrast agents
- •Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator
- •inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study
- •Baseline (routine care) CCTA performed < 2 years or > 5 years before inclusion
结局指标
主要结局
progression of total coronary plaque volume (mm3)
时间窗: Between baseline (retrospective) and follow up CCTA (interval 2-5 years).
The primary study parameter will be the progression of total coronary plaque volume (mm3). This will be calculated by subtracting the coronary plaque volume measured in the first CCTA from the total plaque volume measured in the follow-up CCTA. The plaque volume will be determined by dividing the total plaque volume by the total vesssel volume
次要结局
- Progression of non-calcified plaque volume (mm3)(Baseline (retrospective) and follow up CCTA (interval 2-5 years))
- Progression of low attenuation plaque volume (mm3)(Baseline (retrospective) and follow up CCTA (interval 2-5 years))
- Changes in coronary artery calcium score(Baseline (retrospective) and follow up CCTA (interval 2-5 years))
- Changes in the number of high-risk plaque characteristics(Baseline (retrospective) and follow up CCTA (interval 2-5 years))
- Changes in peri coronary fat attenuation index(Baseline (retrospective) and follow up CCTA (interval 2-5 years))
- Changes in Coronary Artery Disease Reporting and Data Scale(CAD-RADS) scores(Between baseline (retrospective) and follow up CCTA (interval 2-5 years))
- Progression of calcified plaque volume (mm3)(Baseline (retrospective) and follow up CCTA (interval 2-5 years))
- The number of cardiovascular events(Baseline CCTA untill 10 years follow up after inclusion)
研究者
M.M. Winter
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)