NCT04866667已完成不适用
Screening and Intervention of Arteriosclerotic Cardiovascular Disease in Type 2 Diabetes in Zhejiang Province
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- New-onset cardiovascular events
研究概览
简要总结
The aim of this study is to screen patients with type 2 diabetes with high risk of cardiovascular disease, and intervene with or without Glucagon like peptide-1 receptor agonists.
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
- •Type 2 diabetes
- •HbA1c ≥7.0%
- •Prior CVD cohort: age ≥50 and ≥1 of the following criteria.
- •Prior stroke or TIA
- •Prior coronary, carotid or peripheral arterial revascularization
- •N50% stenosis of coronary, carotid, or lower extremity arteries
- •History of symptomatic CHD documented by Positive exercise stress test or any cardiac imaging or Unstable angina with ECG changes
- •Asymptomatic cardiac ischemia Documented by positive nuclear imaging test, exercise test or dobutamine stress echo
- •Chronic heart failure NYHA class II-III
- •Chronic renal failure, eGFR <60 mL/min per 1.73m2 MDRD eGFR <60 mL/min per Cockcroft-Gault formula
- •No Prior CVD group: Age ≥60 y and ≥1 of the following criteria.
- •Microalbuminuria or proteinuria
- •Hypertension and left ventricular hypertrophy by ECG or imaging
- •Left ventricular systolic or diastolic dysfunction by imaging
- •Ankle-brachial index b0.9
排除标准
- •Type 1 diabetes
- •other type diabetes
- •Calcitonin ≥50 ng/L
- •Use of a GLP-1 receptor agonist (exenatide, liraglutide or other) or pramlintide or any DPP-4 inhibitor within the 3 months prior to screening
- •Use of insulin other than human NPH insulin or long-acting insulin analogue or premixed insulin within 3 months prior to screening. Shortterm use of other insulin during this period in connection with intercurrent illness is allowed, at Investigators discretion
- •Acute decompensation of glycemic control
- •An acute coronary or cerebrovascular event in the previous 14 d
- •Currently planned coronary, carotid, or peripheral artery revascularization
- •Chronic heart failure (NYHA class IV)
- •Current continuous renal replacement therapy
- •End-stage liver disease
- •History of solid organ transplant or awaiting solid organ transplant
- •Malignant neoplasm
- •Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
- •Personal history of non-familial medullary thyroid carcinoma
研究组 & 干预措施
antidiabetic drugs including GLP-1 RAs
Apply Type 2 Diabetes mellitus patients with high risk of ASCVD with antidiabetic drugs including GLP-1 RAs
antidiabetic drugs not including GLP-1 RAs
Apply Type 2 Diabetes mellitus patients with high risk of ASCVD with antidiabetic drugs not including GLP-1 RAs，such as metformin，insulin
结局指标
主要结局
New-onset cardiovascular events
时间窗: maximum 2 years
Composite of angina pectoris, stroke, myocardial infarction, atherosclerotic plaque，unplanned rehospitalization, stent thrombosis, incidence of cardiac death in the duration of follow-up
次要结局
- Lipid levels(maximum 2 years)
- Blood glucose control(maximum 2 years)
- Body weight(maximum 2 years)
- Microvascular complications(maximum 2 years)
- Blood pressure level(maximum 2 years)
- Fat Distribution Indicators(maximum 2 years)
研究者
Xiao Ye, MD
Director Assistant
Zhejiang Provincial People's Hospital
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Multifactorial Treatment of Cardiovascular Risk in Diabetic Patients: Identification of Treatment Non-RespondersDiabetes Mellitus, Type IINCT00660790Medical University of Graz97
已完成
不适用
An International Survey of the Occurrence of Diseases That Affects the Heart and Blood Vessels Among People With Type 2 DiabetesDiabetes Mellitus, Type 2NCT03786406Novo Nordisk A/S2,275
已完成
不适用
An International Survey of the Occurrence of Cardiovascular Disease Among Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT03811288Novo Nordisk A/S7,548
已完成
3 期
Action to Control Cardiovascular Risk in Diabetes (ACCORD)Cardiovascular DiseasesAtherosclerosisCoronary DiseaseHypertensionDiabetes MellitusHypercholesterolemiaDiabetes Mellitus, Type 2NCT00000620National Heart, Lung, and Blood Institute (NHLBI)10,251
Unknown
不适用
Progression of Coronary Atherosclerosis in Asymptomatic Diabetic SubjectsType 2 DiabetesCoronary Artery DiseaseNCT02109835British Cardiac Research Trust250