Effects of Low Frequency Magnetic Field on Exercise Induced Angina

NCT ID: NCT01423422

Last Updated: 2011-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-10-31

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).

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.

Conditions

Angina Exacerbation Acute

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Frequency exposed patients

Patients exposed to the magnetic field with the specific frequency

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: collaborator

Aerotel Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ilan Hai, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiac Rehabilitation Institute, Sheba Medical Center

Locations

Cardiac Rehabilitation Institute, sheba Medical Center

Tel Litwinsky, , Israel

Countries

Israel

Central Contacts

Robert Klempner, MD

Role: CONTACT

Robert.Klemper@sheba.health.gov.il

972-3-5302361

Facility Contacts

Robert Klemper, MD

Role: primary

Robert.Klemper@sheba.health.gov.il

972-3-5302361

References

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.

Reference Type: BACKGROUND

PMID: 19588249 (View on PubMed)

Other Identifiers

frequency medicine for angina

Identifier Type: -

Identifier Source: org_study_id