跳至主要内容
临床试验/NCT01002989
NCT01002989已完成不适用

Assessment of the Oscillometric Measurement of the Ankle-brachial Index (ABI) With WatchBP Office ABI Device.

University of Athens1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
98
试验地点
1
主要终点
Mean Doppler Ankle-Brachial Index

研究概览

简要总结

Measurement of the ankle-brachial index (ABI) with the oscillometric device WatchBP Office will be assessed compared to the reference method (Doppler).

Ninety three adult subjects assessed for hypertension, treated or untreated, with complete study data were included. Data on the presence of cardiovascular (CV) disease and classical CV risk factors were recorded.

All the ABI measurements of each individual participant will be performed by the same observer in a randomized order (concerning Doppler and WatchBP)

详细描述

All study measurements were performed under standardized conditions in a quiet examination room with 10 min rest in the supine position before measurements. Ankle-brachial index (ABI) was measured manually by Doppler and automatically by the oscillometric device in randomized order by a single investigator. Manual Doppler ABI was measured according to the American Heart Association guidelines using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe. Systolic blood pressure was defined with a standard mercury sphygmomanometer by the first Doppler flow signal while deflating the cuff from a suprasystolic level in brachial, dorsalis pedis and posterior tibial arteries. Systolic pressure was determined sequentially for brachial, dorsalis pedis and posterior tibial arteries for each side and ABI was calculated for each leg by dividing the highest ankle pressure to the highest arm pressure. Automated ABI measurement was performed using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland). This device allows automated simultaneous both arms or arm and leg blood pressure measurements and thereby the calculation of ABI. The ABI results are displayed on the device screen.

The study protocol included three steps: (i) an introductory familiarization automated ABI measurement, (ii) three simultaneous oscillometric both arms blood pressure measurements; in case of a consistent inter-arm difference ≥12 mmHg, the arm with the higher blood pressure was selected for the subsequent oscillometric ABI measurements (otherwise the right arm was used) and (iii) Doppler and automated ABI measurement in randomized order; Doppler ABI was measured once, whereas automated ABI calculation included triplicate simultaneous arm-leg measurements performed for each side. The occurrence of five sequential oscillometric errors was defined as a failure of the oscillometric device to measure ABI.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
25 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Treated or untreated subjects assessed for hypertension

排除标准

  • Atrial fibrillation
  • Incompressible ankle arteries

结局指标

主要结局

Mean Doppler Ankle-Brachial Index

时间窗: once (cross-sectional)

Watch BP Office Minus Doppler Ankle-Brachial Index Difference

时间窗: once (cross-sectional)

The validation process consisted of two parts: (i) measurement validation, which compared Doppler and Watch BP Office ABI values and assessed their association, and (ii) clinical validation, which compared the diagnosis of peripheral artery disease (PAD) by the two methods and assessed the association of Watch BP Office and Doppler ABI values with cardiovascular risk factors.

Mean Watch BP Office Ankle-Brachial Index

时间窗: once (cross-sectional)

次要结局

  • Agreement Between the Two Methods in Peripheral Artery Disease (PAD) Diagnosis(Once (cross-sectional))

研究者

发起方
University of Athens
申办方类型
Other
责任方
Principal Investigator
主要研究者

George S. Stergiou

Associate Professor of Medicine and Hypertension

University of Athens

研究点 (1)

Loading locations...

相似试验