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临床试验/EUCTR2012-000201-72-GB
EUCTR2012-000201-72-GB进行中(未招募)1 期

The Effects of Inorganic Nitrite on cardiac and skeletal muscle: Physiology, Pharmacology and Therapeutic Potential. Peripheral Arterial Disease - Effects of Inorganic Nitrite on skeletal muscle: PAD

niversity of Aberdeen0 个研究点目标入组 132 人开始时间: 2012年4月13日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
132

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • Patients with stable intermittent claudication 1) of at least 3 months duration 2) with clinical findings of peripheral vascular disease and 3) an ABPI<0.9.
  • Strict attention will be paid to secondary prevention measures and patients will be advised to exercise regularly. Patients will not be offered supervised exercise therapy. Dietary nitrite/nitrate intake will be assessed via a short questionnaire. Patients with a high dietary intake will not be excluded from the study as we wish to assess the effects or oral sodium nitrate supplementation on platelet function irrespective if a patient’s diet.
  • They should be able to walk for at least one minute on a treadmill using the Skinner-Gardner protocol and the variability in absolute claudication distance (ACD) between two consecutive baseline tests performed within a two week period should be less than 25%.
  • Patients must be on a statin and aspirin for at least six weeks prior to being enrolled in this study. Patients on pentoxyifylline, cilostazol, or dietary supplements such as omega-3 fatty acids and l-arginine will require a 1 month washout period prior to enrolment.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 132
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 132

排除标准

  • Patients with the following will be excluded:
  • rest pain or ulceration
  • recent arterial revascularisation (within the past 3 months)
  • other co-morbidities that may impede the patient’s ability to perform an exercise test (arthritis, severe coronary artery disease or chronic obstructive pulmonary disease)
  • Patients on clopidogrel
  • oral nitrate preparations

研究者

发起方
niversity of Aberdeen

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