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临床试验/NCT05264090
NCT05264090已完成不适用

Seven-day Ambulatory Blood Pressure Monitoring and CAVI in the Prevention of Cardiovascular Diseases

St. Anne's University Hospital Brno, Czech Republic1 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2018年6月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
171
试验地点
1
主要终点
The risk rate of incorrect patient classification based on night-to-day ratio specification from singular 24-h ABPM in comparison to the results of 7-day ABPM monitoring.

研究概览

简要总结

Specify the risk rate of incorrect patient classification based on night-to-day ratio specification from singular 24-h ABPM in comparison to the results of 7-day ABPM monitoring

详细描述

The subjects in the study are divided into 4 groups:

group 1 (40 healthy men and women without exercise); group 2 (40 healthy exercise-training men and women); group 3 (40 patients with ischemic coronary artery disease without exercise); and group 4 (51 patients with ischemic coronary artery disease following cardiovascular rehabilitation).

The subject of the evaluation is the percentage rate of incorrect subject classification (dipper, non-dipper, extreme dipper, and risers) based on the mean blood pressure values for 7 days and from seven independent 24-hour cycles (the mean value mode).

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy volunteers (without any disease, including the cardiovascular ones, and without any kind of treatment)
  • •Patients with chronic ischemic coronary artery disease
  • •Patients treated with ACE inhibitors, beta-blockers or statins.
  • •To visit routinely in the health centres where the study is carried out

排除标准

  • •Age under 18 years,
  • •Pregnant, or breast-feeding,
  • •Patients on dialysis or being followed by nephrology,
  • •Severe physical or cognitive limitations,
  • •Intolerance to the method of measurement

研究组 & 干预措施

Group 1

Placebo Comparator

Healthy volunteers without exercise

干预措施: Ambulatory blood pressure monitoring (Other)

Group 2

Sham Comparator

Healthy exercise-training volunteers

干预措施: Ambulatory blood pressure monitoring (Other)

Group 2

Sham Comparator

Healthy exercise-training volunteers

干预措施: Combined aerobic-resistance exercise (Other)

Group 3

Active Comparator

Patients with ischemic coronary artery disease without exercise

干预措施: Ambulatory blood pressure monitoring (Other)

Group 4

Experimental

Patients with ischemic coronary artery disease following cardiovascular rehabilitation

干预措施: Ambulatory blood pressure monitoring (Other)

Group 4

Experimental

Patients with ischemic coronary artery disease following cardiovascular rehabilitation

干预措施: The cardiovascular exercise (Other)

结局指标

主要结局

The risk rate of incorrect patient classification based on night-to-day ratio specification from singular 24-h ABPM in comparison to the results of 7-day ABPM monitoring.

时间窗: 1 - 7 days

Primary outcome was to specify the risk rate of incorrect patient classification based on night-to-day ratio specification from singular 24-h ABPM in comparison to the results of 7-day ABPM monitoring. The percentage of blood pressure drop at night expressed by night-to-day ratio (dippers, non-dippers, extreme dippers, reverse dippers) can be specified much more accurately on the basis of 7-day ABPM values. ABPM restricted to 24 h, as currently practiced, does not yield a sufficiently reliable estimate of the night-to-day ratio for a classification in terms of dipping. Extending monitoring to 7 days accounts for the large day-to-day variability in the night-to-day ratio, and may yield a more reliable diagnosis of blood pressure variability.

次要结局

  • Optimalization of the blood pressure diagnostic through comparing of 24 hours and 7 days monitoring.(1 - 7 days)

研究者

发起方
St. Anne's University Hospital Brno, Czech Republic
申办方类型
Other
责任方
Sponsor

研究点 (1)

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