Cardiac Magnetic Resonance Imaging in Type 2 Diabetes Mellitus: The Næstved/Slagelse/Ringsted Cohort
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Clinical factors associated with worsening of diabetic cardiomyopathy after 5 years
研究概览
简要总结
This study aims to investigate the myocardial phenotype of patients with type 2 diabetes. From 2016-2019 the investigators recruited a cohort of 296 subjects with type 2 diabetes. All subjects underwent clinical examinations including a gadolinium contrast cardiac MRI.
The current study is a clinical follow-up study of the subjects, thus, the investigators will invite all participants to a reevaluation with cardiac MRI.
Additionally, the investigators will aim at recruiting additionally 400 patients with type 2 diabetes.
The aim it to characterize the phenotype of diabetic cardiomyopathy. Uniquely using cardiac MRI we can measure myocardial microvascular function, myocardial localised and diffuse fibrosis in addition to the quantification of myocardial structure and systolic and diastolic function.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Few and simple, allowing for a broad cohort.
- •Male or female fully capable of providing informed consent
- •Informed consent
- •Age 18-80 (both included)
- •T2DM diagnosed at least 3 months prior to inclusion in the study
排除标准
- 未提供
结局指标
主要结局
Clinical factors associated with worsening of diabetic cardiomyopathy after 5 years
时间窗: 5 years follow-up
Clinical factors :Albuminuria, autonomic neuropathy, retinopathy, HbA1c, hs-CRP. Signs of worsening af diabetic cardiomyopathy: Increased myocardial extracellular volume, decreased myocardial blood flow and myocardial perfusion reserve, decreased strain (GLS; GCS, GRS), increasing E/e´, increasing concentri remodeling index(LV mass / LV end-diastolic volume)
The association of pericardial- and epicardial fat with myocardial function and MACE after 5 year
时间窗: Baseline and at 5 years follow-up
Myocardial function: LVEF, LV strain (GLS, GCS, GRS), E/e´, myocardial extracellular volume, myocardial perfusion ratio. MACE defined as CVD events (AMI, HF, stable angina, atrial fibrillation, ventricular arytmia), stroke, death
Association of myocardial microvascular function in patients with type 2 diabetes with MACE after 5 years
时间窗: 5 years follow-up
Myocardial microvascular function is measured by the myocardial perfusion ratio, quantified by cardiac MRI. MACE defined as CVD events (AMI, HF, stable angina, atrial fibrillation, ventricular arytmia), stroke, death
Impact of myocardial perfusion and cardiac cardiac output on perfusion in other organs (kidney, spleen, liver) assed by gadolinium contrast magnetic resonance imaging
时间窗: Baseline and at 5 years follow-up
Myocardial perfusion measured by myocardial blood flow and myocardial perfusion ratio quantified by cardiac MRI.
次要结局
- Characterization of the progression of diabetic cardiomyopathy over 5 years, including LV+RV function, the coronary microvascular function, the coronary macrovascular function, fibrosis, aortic stiffness, per and epicardial fat, perfusion of other organs(5 years follow-up)