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临床试验/NCT03138122
NCT03138122进行中(未招募)不适用

The Study of Men Born in 1943 - A Longitudinal Cohort Study From Middle-Age and Onward

Sahlgrenska University Hospital, Sweden1 个研究点 分布在 1 个国家目标入组 798 人开始时间: 1993年2月9日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
798
试验地点
1
主要终点
Cardiovascular diseases

研究概览

简要总结

A random sample a random sample of half of all men born in 1943 and living in the city of Gothenburg, Sweden, have been investigated in 1993 at 50 years of age and will be followed continuously with repeated re-examinations and follow-up concerning mortality and cardiovascular diseased. Out of 1463 invited men, 798 (54.5%) accepted the invitation and is included in this longitudinal cohort study.

详细描述

In January 1993 a random sample of half of all men born in 1943 and living in the city of Gothenburg, Sweden, was selected and invited to participate a longitudinal observational cohort study. Out of 1463 invited men, 798 (54.5%) accepted the invitation and were examined for 1st time between February 1993 and June 1994. All participants, at 50 years of age, underwent a physical examination including anthropometric measurements, blood pressure and ECG. Several questionaires about previous diseases, life style, physical stress, family history, medications, symptoms and psychosocial factors were included. Blood samples were drawn from an antecubital vein after a nights fast. Basal laboratory analysis were performed. In addition several samples of whole blood, serum and plasma were stored in a freezer (-80○ Celsius) for later analysis.

In 2003, at 60 years of age, a 2nd examination was performed with similar methodology and examination´s. At this time 655 of the original 798 men participated.

A 3rd examination was performed between May 2014 and December 2014. In addition to physical examinations, questionnaires and laboratory analysis an echocardiographic examination, a sleep recording, screening for atrial fibrillation with thumb-EKG and investigation with Arteriography was added.

Echocardiographic examinations were performed by experienced cardiologist in accordance with clinical routine using ultrasound system (Vivid 7 Dimension, GE Medical systems, Horten, Norway), together with commercially available analysis software (GE Vingmed Ultrasound EchoPAC PC, General Electric Healthcare, Little Chalfont, UK) and in agreement with ESC guideline for echocardiography EAE recommendations.

The sleep recording was conducted for one night in the patients home using Apnélink, Apnélink plus or Apnélink air. All participants also answered the Epworth sleepiness scale (ESS) and the functional outcome of sleep questionnaire (FOSQ).

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
50 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Men born in 1943 and living in the city of Gothenburg, Sweden

排除标准

  • 未提供

结局指标

主要结局

Cardiovascular diseases

时间窗: from date of first examination until the date of endpoint or date of death from any cause, whichever come first assessed up to 20, 30, 40 and 50 years

Alla major cardiovascular events including cardiovascular death, myocardial Infarction, congestive heart failure atrial fibrillation, stroke and venous thromboembolism

次要结局

  • Sleep apnoea syndrome(at 71 years of age)

研究者

发起方
Sahlgrenska University Hospital, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Per-Olof Hansson

M.D, Ph.D.,

Sahlgrenska University Hospital, Sweden

研究点 (1)

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