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临床试验/NCT02223143
NCT02223143Unknown不适用

A Registration Study for Primary and Secondary Prevention in Dyslipidemic Taiwanese

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 35,000 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
35,000
试验地点
1
主要终点
The time to first occurrence of a major cardiovascular event

研究概览

简要总结

Cardiovascular disease (CVD), including coronary heart disease (CHD) and stroke, is a leading cause of morbidity and mortality. Dyslipidemia has long been recognized to be the most important risk factor in the development of atherosclerosis in human beings. In Taiwan, the rates for hypercholesterolemia (≧250mg/dl) were 4.3% and 5.5% in 1970; 12.99% in 1980; and 17.1% in 1990. Those for hypertriglyceridemia (≧200 mg/dl) were 6.5% and 11.1% in 1970 and 13.0% in 1990. Low serum HDL-C was an isolated and independent coronary risk factor among a good number of Taiwanese people. Lowering of low-density lipoprotein cholesterol (LDL-C) with statins has in the last decade become part of the standard treatment regimen in patients with dyslipidemia. However, most embarrassing, is the insufficient data for clinical use in Taiwan. It is necessary to have rationalized and balanced guideline for the management of dyslipidemia in Taiwan, based on our local epidemiological, clinical and basic research data. Because all these trials were conducted in Caucasians and no large-scaled end-point research about the lipid lowering therapy (LLT) was published in Asians before, this registry study attempts to define the status of lipid lowering therapy in Taiwan and the effect of LLT on CVD morbidity and mortality in a large population of patients receiving primary or secondary prevention therapy. The medications will only depend on the decision made by the primary care physicians. The patient or physician can decide to be withdrawn from this registry at any time because of any reason. The lipid profile change, myopathy, or liver enzyme change after the LLT will also be recorded.

详细描述

This is a registry study to define the status of lipid lowering therapy in Taiwan and the effect of LLT on CVD morbidity and mortality in a large population of patients receiving primary or secondary prevention therapy. The medications will only depend on the decision made by the primary care physicians. The patient or physician can decide to be withdrawn from this registry at any time because of any reason.

All potential patients will be screened for the eligibility in a screening visit. Those who fill the inclusion criteria at screening will be invited for the registry study into different groups. The follow-up will take place yearly thereafter for 5 years, through clinical visiting, phone follow-up, or records from the NHIB Taiwan. At each clinical visit, vital signs, clinical endpoints, adverse events, concurrent medication information and laboratory specimens will be obtained as complete as possible. With phone or records from NHIB, only clinical endpoints will be recorded. If the primary care physician intends to treat the patient's lipid profile to the target, he/she can add, delete or adjust the LLT by his/her clinical judgement.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • One with atherosclerotic vascular diseases
  • One without ASVD but with at least 1 CV risk factor
  • Apparent healthy persons

排除标准

  • One with hemodynamically significant valvular or congenital heart disease
  • One with any non-cardiovascular diseases which may affect prognosis

结局指标

主要结局

The time to first occurrence of a major cardiovascular event

时间窗: up to 5 years

The major CV (cardiovascular) event will be defined as CV death, hospitalization for nonfatal MI (myocardial infarction) or stroke, or cardiac arrest with resuscitation

次要结局

  • Composite cardiovascular outcome(up to 5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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