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Effects of Low Frequency Magnetic Field on Exercise Induced Angina

This study is not yet open for participant recruitment.
Verified August 2011 by Aerotel Ltd
Sponsor:
Collaborator:
Sheba Medical Center
Information provided by (Responsible Party):
Aerotel Ltd
ClinicalTrials.gov Identifier:
NCT01423422
First received: August 24, 2011
Last updated: August 25, 2011
Last verified: August 2011
History of Changes
  Purpose

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
Angina Exacerbation Acute

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Low Frequency Electromagnetic Field on Patients With Exercise Induced Angina

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aerotel Ltd:

Primary Outcome Measures:
  • Exercise workload for a given ECG change [ Time Frame: within a month from the second exercise stress test ] [ Designated as safety issue: No ]
    Exercise workload wil be compared between the two tests and according with the ECG changes recorded at these two tests.


Secondary Outcome Measures:
  • Angina scale [ Time Frame: Within a month from the last exercise stress test ] [ Designated as safety issue: No ]
    Define the angina scale obtained between the two tests at a given workload.


Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Frequency exposed patients
Patients exposed to the magnetic field with the specific frequency

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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423422

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

Locations
Israel
Cardiac Rehabilitation Institute, sheba Medical Center Not yet recruiting
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
Principal Investigator: Ilan Hai, MD Cardiac Rehabilitation Institute, Sheba Medical Center
  More Information

Publications:

Responsible Party: Aerotel Ltd
ClinicalTrials.gov Identifier: NCT01423422     History of Changes
Other Study ID Numbers: frequency medicine for angina
Study First Received: August 24, 2011
Last Updated: August 25, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Aerotel Ltd:
Exercise stress test
Effort Angina
Exercise induced angina

Additional relevant MeSH terms:
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013