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临床试验/NCT02713724
NCT02713724Unknown不适用

Effects of a Personalized Training Program on Trans-thoracic Adenosine-assisted Coronary Flow Reserve in Healthy Volunteers

Göteborg University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Coronary flow reserve (CFR)

研究概览

简要总结

This study investigates whether an individualized exercise program, including a personal trainer, can improve cardiovascular status quantified with ultrasound to assess coronary flow reserve and other non-invasive techniques. The subjects in the study will be divided into two groups; one group will have a personalized exercise- and nutrition program and the other group will have acess to a gym membership, but no personal trainer.

详细描述

Coronary heart disease is one of our most common diseases that causes significant morbidity and mortality. Because the risk of serious cardiovascular events, such as myocardial infarction and death, is evident in this patient population, it is of utmost importance to develop diagnostic methods to identify patients at risk. The most appropriate diagnostic methods are those that are safe to implement for both patient and physician, but also accessible and cost-efficient.

By using non-invasive techniques such as ultrasound, coronary artery function can be examined as coronary flow reserve (CFR). In the platform of non-invasive techniques used by the investigators for examinations of cardiovascular status, other methods are included, such as measurement of intima-media thickness in the carotid and radial arteries. The investigators goal is to compare the group with the personalized program with its placebo, and to compare the two study-groups with each other, to investigate whether the personalized program provides greater health benefits.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • non-smokers
  • no current medication,
  • no known diseases that require regular medication
  • no known risk factor for cardiovascular disease (hypertension, hyperlipidemia, diabetes, heredity, obesity, peripheral vascular disease)
  • no physically fit athletes.

排除标准

  • ongoing treatment with medicine containing dipyridamole (asasantin, persantin)
  • known hypersensitivity to adenosine
  • chronic obstructive pulmonary disease
  • atrial fibrillation or other obvious arrythmias
  • AV-block grade 2 or higher
  • other serious illness

结局指标

主要结局

Coronary flow reserve (CFR)

时间窗: 3-6 months

Ultrasound-assessed coronary flow reserve. Data will be presented as a ratio (no unit) between maximal mean hyperemia flow velocity and baseline velocity

次要结局

  • endothelial function(3-6 months)
  • cIMT (carotid artery intima-media thickness)(3-6 months)
  • cardiovascular biomarkers(3-6 months)
  • metabolic biomarkers(3-6 months)
  • QoL (quality of life)(3-6 months)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Svedlund

MD PhD

Göteborg University

研究点 (2)

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