Angina Exacerbation AcuteNCT01423422
Effects of Low Frequency Magnetic Field on Exercise Induced Angina
An observational study of Angina Exacerbation Acute, run by Aerotel Ltd at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Angina Exacerbation Acute
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2011to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients enrolled at the Cardiac Rehabilitation Institute, sheba Medical Center
Who may be able to join
- Patients with known exercise-induced-angina
Who cannot join
- Patients that changed treatment course between the two exercise stress tests Patients that decided to drop from the second exercise stress test
Trial locations and contacts
1 site in 1 country.
Israel1 site
Cardiac Rehabilitation Institute, sheba Medical Center
Tel HaShomer, 52621
Robert Klemper, MD, 972-3-5302361, Robert.Klemper@sheba.health.gov.il
Robert Klemper, MD
About this study
Official title: 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).
Read the 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
- Keywords
- Exercise stress test, Effort Angina, Exercise induced angina
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Frequency exposed patients | Patients exposed to the magnetic field with the specific frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise workload for a given ECG change
Exercise workload wil be compared between the two tests and according with the ECG changes recorded at these two tests.
Measured: within a month from the second exercise stress test
Secondary outcomes (1)
Angina scale
Define the angina scale obtained between the two tests at a given workload.
Measured: Within a month from the last exercise stress test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angina Exacerbation AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aerotel Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center
- Responsible party
- Sponsor
- Investigators
- Ilan Hai, MD, Principal investigator, Cardiac Rehabilitation Institute, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423422
- Sponsor's protocol ID
- frequency medicine for angina
- Status last verified
- Aug 2011
- First submitted
- 24 Aug 2011
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19588249
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Frequency Electromagnetic Field on Patients With Exercise Induced Angina
- ClinicalTrials.gov ID
- NCT01423422
- Acronym / sponsor ID
- frequency medicine for angina
- Conditions
- Angina Exacerbation Acute
- Keywords
- Exercise stress test, Effort Angina, Exercise induced angina
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aerotel LtdIndustry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center
- Study start
- Nov 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 26 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frequency exposed patients | – | –Patients exposed to the magnetic field with the specific frequency |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled at the Cardiac Rehabilitation Institute, sheba Medical Center
Key inclusion criteria (1 listed)
- Patients with known exercise-induced-angina
Key exclusion criteria (1 listed)
- Patients that changed treatment course between the two exercise stress tests Patients that decided to drop from the second exercise stress test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Angina scale
Time frame: Within a month from the last exercise stress test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2011.
- Background: PubMed 19588249Barzelai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilan Hai, MD principal investigator
Cardiac Rehabilitation Institute, Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina Exacerbation Acute, run by Aerotel Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Klempner, MD (972-3-5302361, Robert.Klemper@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise workload for a given ECG change (time frame: within a month from the second exercise stress test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01423422, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2011.