ACTRN12621001475831招募中未知
A multicentre, parallel-group, randomised controlled trial to determine the effect of a holistic, multidisciplinary medical management program on control of key cardiovascular risk factors in people with peripheral artery disease
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 246
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. PAD, defined from prior diagnosis by an appropriately qualified specialist including vascular surgeon, cardiologist or internal medicine specialist. PAD diagnosis will consider symptoms, clinical examination, past requirement for surgical treatment of PAD and available investigations including ankle brachial index (ABI), duplex ultrasound or angiography. Acceptable definitions will include ABI <0.9 or >1.4, absence of pedal pulses with relevant symptoms, prior requirement for lower limb peripheral artery open surgical or endovascular procedure to treat athero-thrombosis or imaging (including ultrasound, digital subtraction angiography, computed tomography or magnetic resonance imaging) evidence of lower limb artery stenosis (at least 50%) or occlusion;
- •2. At least 18 years old and able to provide valid informed consent;
- •3. Able to verbally communicate with the trial staff in English.
排除标准
- •1. Enrolled in another clinical trial;
- •2. Optimal risk factor control (i.e. PAD-medical score 6);
- •3. Unwilling or unable to engage with technology required for intervention;
- •4. Terminal illness with a prognosis of less than 6 months.
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