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Effects of Low Frequency Magnetic Field on Exercise Induced Angina

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ClinicalTrials.gov Identifier: NCT01423422
Recruitment Status : Unknown
Verified August 2011 by Aerotel Ltd.
Recruitment status was:  Not yet recruiting
First Posted : August 26, 2011
Last Update Posted : August 26, 2011
Sponsor:
Collaborator:
Sheba Medical Center
Information provided by (Responsible Party):
Aerotel Ltd

August 24, 2011
August 26, 2011
August 26, 2011
November 2011
May 2012   (Final data collection date for primary outcome measure)
Exercise workload for a given ECG change [ Time Frame: 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.
Same as current
No Changes Posted
Angina scale [ Time Frame: Within a month from the last exercise stress test ]
Define the angina scale obtained between the two tests at a given workload.
Same as current
Not Provided
Not Provided
 
Effects of Low Frequency Magnetic Field on Exercise Induced Angina
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).
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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients enrolled at the Cardiac Rehabilitation Institute, sheba Medical Center
Angina Exacerbation Acute
Not Provided
Frequency exposed patients
Patients exposed to the magnetic field with the specific frequency
Barzelai S, Dayan A, Feinberg MS, Holbova R, Laniado S, Scheinowitz M. Electromagnetic field at 15.95-16 Hz is cardio protective following acute myocardial infarction. Ann Biomed Eng. 2009 Oct;37(10):2093-104. doi: 10.1007/s10439-009-9758-2. Epub 2009 Jul 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
Same as current
October 2012
May 2012   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
35 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01423422
frequency medicine for angina
No
Not Provided
Not Provided
Aerotel Ltd
Aerotel Ltd
Sheba Medical Center
Principal Investigator: Ilan Hai, MD Cardiac Rehabilitation Institute, Sheba Medical Center
Aerotel Ltd
August 2011