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
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