Effects of Low Frequency Magnetic Field on Exercise Induced Angina

• Conditions: Angina Exacerbation Acute

• Registration Number: NCT01423422
• Lead Sponsor: 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).

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.

Study Timeline

• Status Verified: 2011-08
• Study First Submitted: 2011-08-24
• Study First Submitted QC: 2011-08-25
• Last Update Submitted: 2011-08-25
• Study First Posted: 2011-08-26
• Last Update Posted: 2011-08-26
• Study Start: 2011-11
• Primary Completion: 2012-05
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exercise workload for a given ECG change	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

Name	Time	Method
Angina scale	Within a month from the last exercise stress test	Define the angina scale obtained between the two tests at a given workload.

Trial Locations

Locations (1)

Cardiac Rehabilitation Institute, sheba Medical Center; 🇮🇱 Tel-Hashomer, Israel