跳至主要内容
临床试验/NCT01423422
NCT01423422Unknown不适用

Effects of Low Frequency Electromagnetic Field on Patients With Exercise Induced Angina

Aerotel Ltd1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
Aerotel Ltd
入组人数
40
试验地点
1
主要终点
Exercise workload for a given ECG change

研究概览

简要总结

The investigators have previously shown that a frequency of 15.95-16.00 Hz protects against acute myocardial infarction in rats. In the current study the investigators would like to investigate whether this frequency enables cardiac patients with exercise-induced chest pain to exercise at higher workload and heart rate. Therefore, patients will undergo two exercise stress tests, one test after being exposed to 30 minutes of the above mentioned frequency and another test after being exposed to sham (no frequency is turned ON). The investigators will measure changes in the electrocardiogram (ECG), workload, exercise time, and subjective measure of chest pain (angina).

详细描述

Several studies have shown that low frequency electromagnetic field has biological and therapeutic potential on the human body, however, to very limited extent on the heart. In the current study cardiac patients suffering from exercise-induced-angina will undergo two consecutive stress tests, one test after being exposed for 30 minutes to the magnetic field and the other test after being exposed to placebo (magnetic field not operated). The order of which the magnet will be operated will be randomly assigned for the patients so a group of patients will be exposed to the magnetic field at their first stress test and another groups of patients will be exposed to the magnetic field at their second stress test. During resting period, and while the patients are subjected to the magnetic field, a 12 lead electrocardiogram (ECG) will be monitored. Thereafter the magnetic field and frequency will be turned off and the patients will be subjected to graded exercise stress test during which they will be monitored for ECG and blood pressure changes. Similar monitoring will be documented during the recovery period following the stress test. In addition, the patients will grade their angina score as documented during the stress test. The data will be compared between the two stress tests and to document any advantageous of the magnetic field on exercise time, workload, ECG changes and/or chest pain.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with known exercise-induced-angina

排除标准

  • Patients that changed treatment course between the two exercise stress tests Patients that decided to drop from the second exercise stress test

结局指标

主要结局

Exercise workload for a given ECG change

时间窗: within a month from the second exercise stress test

Exercise workload wil be compared between the two tests and according with the ECG changes recorded at these two tests.

次要结局

  • Angina scale(Within a month from the last exercise stress test)

研究者

发起方
Aerotel Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验