Comparison of the Ankle-Brachial Index Measurement Using a Specific Oscillometric Device vs. the Doppler Method
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Measurement of the ABI
研究概览
简要总结
Several methods are available to measure ankle brachial index (ABI) non-invasively. A recent scientific statement of the AHA considers the Doppler method as the reference. However because Doppler devices are not widely available in primary care, several attempts have been made to propose alternative methods, among whom oscillometric methods (automatic blood pressure machines) have attracted most attention.
We hypothesize that:
- the diagnostic characteristics (i.e. sensitivity, specificity and AUC) of the oscillometric method would be very good as compared to the Doppler method.
the oscillometric method would have better intra- and inter-observer reproducibilities as compared to the Doppler method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred with the suspicion of PAD, either because of:
- •symptoms in favor of intermittent claudication or more atypical pain when walking, or
- •asymptomatic individuals with the presence of at least 2 cardiovascular risk factors among the following :
- •Men > 60 years or women > 65 years
- •Regular cigarette smoking >10 years, either current or in the past
- •Treated Type-2 diabetes >5 years or Type-1 diabetes >20 years
- •Treated hypertension
- •High blood cholesterol (either total-C >240 mg/dl or LDL-C >160 mg/dl) or treated by statins or other lipid-lowering agents
- •Documented history of coronary artery disease (history of PCI or CABG, or previous myocardial infarction, or CAD documented by coronary angiography)
- •Documented history of ischemic stroke
排除标准
- •Patients with revascularized PAD
- •Patients with critical limb ischemia or leg/foot ulcers
- •Cardiac arrhythmia: Atrial fibrillation, atrial flutter, frequent supra- and ventricular ectopic beats
- •Patients under dialysis
研究组 & 干预措施
Pattern A
Intervention : Each subject has 3 measurements of ABI starting with oscillometric device and then using the Doppler method.
干预措施: Measure ankle brachial index (ABI) (Diagnostic Test)
Pattern B
Intervention : Each subject has 3 measurements of ABI starting with Doppler method and then using oscillometric device.
干预措施: Measure ankle brachial index (ABI) (Diagnostic Test)
结局指标
主要结局
Measurement of the ABI
时间窗: Day of the inclusion
Measurement of the ABI, with Doppler method as reference
次要结局
未报告次要终点