Effects of Low Frequency Magnetic Field on Exercise Induced Angina
2011年8月25日 更新者:Aerotel Ltd
Effects of Low Frequency Electromagnetic Field on Patients With Exercise Induced Angina
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).
研究概览
地位
未知
详细说明
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.
研究类型
观察性的
注册 (预期的)
40
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
-
Tel-Hashomer、以色列、52621
- Cardiac Rehabilitation Institute, sheba Medical Center
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-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
35年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients enrolled at the Cardiac Rehabilitation Institute, sheba Medical Center
描述
Inclusion Criteria:
Patients with known exercise-induced-angina
Exclusion Criteria:
Patients that changed treatment course between the two exercise stress tests Patients that decided to drop from the second exercise stress test
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
|---|
|
Frequency exposed patients
Patients exposed to the magnetic field with the specific frequency
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Exercise workload for a given ECG change
大体时间: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.
|
within a month from the second exercise stress test
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Angina scale
大体时间:Within a month from the last exercise stress test
|
Define the angina scale obtained between the two tests at a given workload.
|
Within a month from the last exercise stress test
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员:Ilan Hai, MD、Cardiac Rehabilitation Institute, sheba Medical Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年11月1日
初级完成 (预期的)
2012年5月1日
研究完成 (预期的)
2012年10月1日
研究注册日期
首次提交
2011年8月24日
首先提交符合 QC 标准的
2011年8月25日
首次发布 (估计)
2011年8月26日
研究记录更新
最后更新发布 (估计)
2011年8月26日
上次提交的符合 QC 标准的更新
2011年8月25日
最后验证
2011年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.