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临床试验/NCT01785511
NCT01785511已完成不适用

Does Ultraviolet Irradiation Reduce Platelet Reactivity and Improve Coronary Microvascular Function in Man?

University of Edinburgh2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2012年3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
12
试验地点
2
主要终点
Coronary Flow Reserve

研究概览

简要总结

Endothelium derived nitric oxide (NO) regulates vascular tone and blood pressure in man. NO also inhibits platelet aggregation and mediates a variety of beneficial anti-inflammatory and repair mechanisms. NO may also be a mediator in the release of the endogenous fibrinolytic factor, tissue-plasminogen activating factor (t-PA) from the endothelium.1 Via these actions it plays a very important role in protection of the vasculature from atherothrombosis and clinical sequelae such as myocardial infarction and stroke.

Visible and ultraviolet (UV) light relax vascular smooth muscles by producing NO in a phenomenon known as photorelaxation.2 The investigators have demonstrated significant stores of pre-formed, bound NO and other nitrosospecies in human skin, which are rapidly released upon exposure to UVA.3 The investigators have demonstrated recently that serum nitrite and nitroso-species are increased after standing in a UVA phototherapy cabinet and that local UVA exposure is associated with increased forearm arterial blood flow that is independent of skin temperature. The investigators have also demonstrated a fall in mean arterial blood pressure in subjects exposed UVA.

Cardiovascular morbidity and the prevalence of hypertension vary with latitude. The investigators hypothesise that some of this geographical variation may be explained by a diminished sunlight/UVA exposure with attendant negative effects upon NO bio-availability.4 To further examine the potential beneficial effects of UVA exposure we will examine the effects of whole-body UVA upon platelet activation and upon myocardial/coronary arterial flow reserve. The investigators will correlate these measures with systemic nitrate, nitrite and nitroso-species content in healthy volunteers.

HYPOTHESES

  1. UVA irradiation enhances coronary flow reserve in healthy volunteers.
  2. UVA irradiation suppresses platelet activation in healthy volunteers.
  3. UVA irradiation enhances the release of endogenous fibrinolytic factors in healthy volunteers.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy male volunteers aged between 18-45 years (inclusive).

排除标准

  • Inability to provide informed consent
  • Co-existent systemic disease (including any history of asthma, reactive airways disease or hypertension)
  • Contraindication to UVA treatment
  • Any history of cardiac conduction abnormality (including bundle branch block or atrial fibrillation)
  • Current intake of aspirin, other non-steroid anti-inflammatory medications or any regular medication.
  • Recent infective/inflammatory condition
  • Echocardiographic evidence of left ventricular hypertrophy (left ventricular septal diameter >1.2 cm in diastole), systolic dysfunction or significant valvular stenosis or regurgitation.

结局指标

主要结局

Coronary Flow Reserve

时间窗: 0, 20, 40 and 60 mins

Change in coronary flow assessed pre and post UVA radiation versus control

次要结局

  • Platelet Activation(0, 20, 40 and 60 mins)
  • Endogenous Fibrinolysis(0, 20, 40 and 60 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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