NCT01423422

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

August 26, 2011

Status Verified

August 1, 2011

Enrollment Period

6 months

First QC Date

August 24, 2011

Last Update Submit

August 25, 2011

Conditions

Keywords

Exercise stress testEffort AnginaExercise induced angina

Outcome Measures

Primary Outcomes (1)

  • 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.

    within a month from the second exercise stress test

Secondary Outcomes (1)

  • Angina scale

    Within a month from the last exercise stress test

Study Arms (1)

Frequency exposed patients

Patients exposed to the magnetic field with the specific frequency

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients enrolled at the Cardiac Rehabilitation Institute, sheba Medical Center

You may qualify if:

  • Patients with known exercise-induced-angina

You may not qualify if:

  • Patients that changed treatment course between the two exercise stress tests Patients that decided to drop from the second exercise stress test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiac Rehabilitation Institute, sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Related Publications (1)

  • 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.

    PMID: 19588249BACKGROUND

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ilan Hai, MD

    Cardiac Rehabilitation Institute, Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2011

First Posted

August 26, 2011

Study Start

November 1, 2011

Primary Completion

May 1, 2012

Study Completion

October 1, 2012

Last Updated

August 26, 2011

Record last verified: 2011-08

Locations