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临床试验/NCT01147952
NCT01147952已完成不适用

A Randomised Trial of the Effect of Exercise on Peripheral Blood Gene Expression in Patients With Stable Angina

Sheffield Teaching Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010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
60
试验地点
2
主要终点
Peripheral blood gene expression

研究概览

简要总结

Regular exercise is known to produce significant health benefits and to reduce the risk of heart diseases, although how this benefit occurs is not well understood. White blood cells are known to be involved in triggering heart attacks, and which genes are switched on or off in white blood cells determines whether they have beneficial or harmful effects. Previous studies, and studies ongoing in our group, have demonstrated measurement of peripheral blood gene expression (which reflects white blood cell gene expression) is able to distinguish between patients with and without coronary artery disease, or patients who are able to develop good compared with poor coronary collateral arteries. Therefore, the gene expression signature in peripheral blood may provide novel diagnostic or prognostic information, and insight into the pathogenesis of heart disease.

We therefore hypothesise that exercise alters peripheral blood gene expression in patients with coronary artery disease and angina. This will identify possible ways that exercise improves angina and reduces the risk of heart disease.

研究设计

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

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Class I to III angina pectoris (classified according to the Canadian Cardiovascular Society [CCS])with documented myocardial ischemia or coronary artery disease on angiography
  • Ability to read and speak English to a level allowing satisfactory completion of written questionnaires and to understand instruction during the exercise programme.

排除标准

  • Acute coronary syndromes or recent myocardial infarction (<2 months)
  • Left main coronary artery stenosis >25% or high-grade proximal left anterior descending artery stenosis
  • Known reduced left ventricular function (ejection fraction <40%)
  • Significant valvular heart disease
  • Insulin-dependent diabetes mellitus
  • Occupational, orthopedic, and other conditions that preclude regular exercise
  • Patients whose ECG prevents interpretation of an exercise test (LBBB, RBBB, pacemaker implantation).
  • Patients who already perform greater than 30min continuous exercise three times weekly (self-reported).

结局指标

主要结局

Peripheral blood gene expression

时间窗: 24 weeks after starting 12 weeks exercise training programme

peripheral blood gene expression

时间窗: 12 weeks after exercise training (or conventional care)

次要结局

  • Depression Score(24wks after starting 12 week exercise programme (or conventional care))
  • Angina status(12wks after starting 12 week exercise programme (or conventional care))
  • Angina Status(24wks after starting 12 week exercise programme (or conventional care))
  • Anxiety Score(24wks after starting 12 week exercise programme (or conventional care))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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