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临床试验/NCT05267990
NCT05267990Enrolling By Invitation不适用

Impact of a Coronary Artery Calcium-guided Primary Prevention of Major Coronary Heart Disease for Asymptomatic Coronary Artery Disease in Diabetes: a Prospective Cohort Study

JuFeng, Hsiao2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
2,000
试验地点
2
主要终点
rate of major coronary heart disease

研究概览

简要总结

To evaluate benefits of primary prevention of major coronary heart disease for asymptomatic coronary artery disease in type 2 diabetes mellitus based on the coronary artery calcium score Our proposal

  1. Based on CAC score, primary early prevention could reduce incidence of major coronary heart disease (CHD) including cardiac mortality, acute myocardial infarction, coronary revascularization
  2. based on CAC score, primary early prevention could reduce all cause mortality, cardiac mortality, cardiovascular disease, heart failure, ischemic stroke, heart failure associated hospitalization and chronic kidney disease and related clinical cost effect

详细描述

Background The patients with type two diabetes mellites increased gradually and heart disease and cerebral vascular disease is the fourth leading cause of mortality. According to the National Health Insurance Research Database (NHIRD) till 2014, incidence of coronary heart disease is 25.2% and heart failure is 3.77%。Multiple complication including chronic kidney disease and cerebrovascular diseases were also well-known.

A systematic review study of scientific evidence from across the world in 2007-2017 revealed cardiovascular disease (CVD) affected 32.2% overall; 29.1% had atherosclerosis, 21.2% had coronary heart disease (CAD), 14.9% heart failure, 14.6% angina, 10.0% myocardial infarction and 7.6% stroke. CVD representing 50.3% of all deaths is a major cause of mortality among people with type 2 Diabetes mellitus (T2DM) (1).A study in Asian population revealed patients with diabetes had a 1.89-fold risk of all-cause death and 2.0-fold risk of cardiovascular death compared with patients without diabetes(2) . However, most diabetes with CAD are asymptomatic.

Coronary artery calcium (CAC) score measured by multi-detector computerized tomography is a reliable measure of subclinical atherosclerosis. The presence, extent and progression of CAC have been shown to predict adverse cardiovascular events better than traditional risk factors and global risk scoring (3-7)。Our previous study in 2020 revealed CAC score could predict long-term cardiovascular outcomes in asymptomatic patients with T2DM (8). 2019 AHA/ACC Guideline on the Primary Prevention of Cardiovascular Disease and 2019 ESC/EAS Guidelines for the management of dyslipidaemias recommend CAC score as a decision making aid for personalized risk management in primary prevention (9,10).This prospective cohort study will invest the impact of a coronary artery calcium-guided primary prevention of major coronary heart disease for asymptomatic coronary artery disease in T2DM.

Objective To evaluate benefits of primary prevention of major coronary heart disease for asymptomatic coronary artery disease in T2DM based on the coronary artery calcium score Our proposal

  1. Based on CAC score, primary early prevention could reduce incidence of major coronary heart disease (CHD) including cardiac mortality, acute myocardial infarction, coronary revascularization
  2. based on CAC score, primary early prevention could reduce all cause mortality, cardiac mortality, cardiovascular disease, heart failure, ischemic stroke, heart failure associated hospitalization and chronic kidney disease and related clinical cost effect.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • more than 40 years old T2DM patients have any one cardiovascular risk as follows
  • total cholesterol>200mg/dl or low density lipoprotein (LDL) >100mg/dl
  • blood pressure>140/90mm/Hg or taking anti-hypertension agents
  • history of smoking
  • family history of early coronary heart diseases
  • proteinuria

排除标准

  • history of cardiovascular diseases such as coronary heart disease, stroke, heart failure etc, pregnant

结局指标

主要结局

rate of major coronary heart disease

时间窗: 5-year followup

cardiac mortality, acute myocardial infarction and coronary revascularization

次要结局

  • rate of mortality(5-year followup)
  • rate of admission(5-year followup)
  • medical expenditure(5-year followup)

研究者

发起方
JuFeng, Hsiao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

JuFeng, Hsiao

doctor

Lotung Poh-Ai Hospital

研究点 (2)

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