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临床试验/NCT01377402
NCT01377402已完成不适用

ARgentinean Risk Assessment Registry in Acute Coronary Syndrome; the ARRA-RACS Study.

Helse Stavanger HF10 个研究点 分布在 2 个国家目标入组 982 人开始时间: 2005年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
982
试验地点
10
主要终点
Total Mortality.

研究概览

简要总结

The first aim of this trial is to assess the long-term prognostic value of Omega-3 index, which is a measure of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) relative to other fatty acids in the erythrocyte membrane, in an unselected, regional multicenter observational study of 982 chest pain patients admitted to the emergency unit, employing blood samples collected at admission.

The second purpose of this study is to evaluate the prognostic utility of vitamin D in the same population.

The third purpose of this study is to assess the incremental prognostic value of B-type natriuretic peptide (BNP) and high-sensitive C-reactive protein (hsCRP).

详细描述

BACKGROUND Cardiac troponins are sensitive markers for myocardial injury in ACS and even a minor elevation of cardiac troponins is associated with an increased risk for future adverse coronary events. However, a detectable troponin release occurs only in a part of patients admitted with ACS. The clinical outcomes and further prognosis of patients with ACS with absent TnT release vary widely, and the identification of potential high-risk patients with troponin negative ACS still remains a major problem in clinical routine. Therefore, the aim of this study is focused on identifying new biomarkers for risk stratification.

Omega- 3 Index: The value of the Omega-3 Index as a prognostic marker in the acute coronary syndromes is still under investigation.

Vitamin D deficiency is positively correlated with cardiovascular risk and N-3 polyunsaturated fatty acids (PUFA's) may reduce the risk of cardiovascular disease. Vitamin D can either be ingested, or created in the skin on exposure to sun, whereas PUFA's are largely incorporated through the diet. Vitamin D deficiency in humans is increasing and its levels are influenced by the color of the skin, geographical location, latitude, altitude, season and daytime.

In addition to Vitamin D, several studies have shown that, N-3 polyunsaturated fatty acids (PUFA's), also have a positive impact on the cardiovascular system. PUFA's are not sufficiently synthesized in the body and are incorporated through the diet. These essential fatty acids are found almost exclusively in oily fish, and have been shown to have a positive impact on several cardiovascular risk factors.

Fish, a source of both Vitamin D and omega-3, is frequently consumed by the costal population of Norway, and is less preferred by the inland beef-consuming population in Northern Argentina. The subtropical location and altitude of Salta, Argentina, is associated with a higher exposure to sun in comparison to the temperate location of Norway. The uptake of Vitamin D in the costal population of Norway may essentially be through the diet, whereas sun exposure may be the essential source of Vitamin D in the Northern Argentinean population.

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

入选标准

  • adults > 18 years able to give informed consent
  • a history of chest pain or other symptoms suggestive of an ACS leading to admission at the emergency unit

排除标准

  • < 18 years of age
  • Unwillingness or incapacity to provide informed consent
  • Prior admission resulting in inclusion in the present study

结局指标

主要结局

Total Mortality.

时间窗: 2-5 years

Mortality for any reason

次要结局

  • Participants With Cardiac Events During Follow-up.(2-5 years)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (10)

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