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Effects of Low Frequency Magnetic Field on Exercise Induced Angina

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Brief Summary:
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).

Condition or disease
Angina Exacerbation Acute

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effects of Low Frequency Electromagnetic Field on Patients With Exercise Induced Angina
Study Start Date : November 2011
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Group/Cohort
Frequency exposed patients
Patients exposed to the magnetic field with the specific frequency



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients enrolled at the Cardiac Rehabilitation Institute, sheba Medical Center
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01423422


Contacts
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Contact: Robert Klempner, MD 972-3-5302361 Robert.Klemper@sheba.health.gov.il

Locations
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Israel
Cardiac Rehabilitation Institute, sheba Medical Center
Tel-Hashomer, Israel, 52621
Contact: Robert Klemper, MD    972-3-5302361    Robert.Klemper@sheba.health.gov.il   
Sub-Investigator: Robert Klemper, MD         
Principal Investigator: Ilan Hay, MD         
Sponsors and Collaborators
Aerotel Ltd
Sheba Medical Center
Investigators
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Principal Investigator: Ilan Hai, MD Cardiac Rehabilitation Institute, Sheba Medical Center
Publications:
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Responsible Party: Aerotel Ltd
ClinicalTrials.gov Identifier: NCT01423422    
Other Study ID Numbers: frequency medicine for angina
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: August 26, 2011
Last Verified: August 2011
Keywords provided by Aerotel Ltd:
Exercise stress test
Effort Angina
Exercise induced angina
Additional relevant MeSH terms:
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Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations