Magnetocardiography (MCG) in Asymptomatic Individuals - Pilot Trial

Healthy Clinical Trial

Official title:

Magnetocardiography (MCG) in Asymptomatic Individuals - Pilot Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00572442
• Other study ID #: 13939
• Status: Withdrawn
• Phase: N/A
• First received: December 12, 2007
• Last updated: November 16, 2009
• Start date: December 2007
• Est. completion date: December 2009

Study information

• Verified date: November 2009
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this research study is to perform serial magnetocardiographs (MCG)and cardiovascular risk factor assessments on individuals with no symptoms or history of heart disease. This small sized study of MCG in healthy individuals will allow for data collection for power analysis for a larger prospective trial.

Volunteers are not compensated or paid.

Description:

The Magnetocardiography (MCG) has been approved by the U.S Food and Drug Administration (FDA) as a tool to measure the heart's magnetic field.However, it is not yet approved for the specific diagnosis of coronary artery disease.

The MCG scan is entirely non-invasive, rapid and no risk, since it does not require stress provocation, radiation, or use of medication or contrast.

In this study, the MCG will be used to compare the scans of normal, healthy volunteers to those which have been previously or are currently being collected in subjects with known heart disease.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 40
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects without chest pain and known heart diseases.

• Subjects > or = 18 years of age.

Exclusion Criteria:

• Heart disease patients

• Patients with chest pain

• Subjects with magnetic metal fragments in the head or torso

• Subjects unable to consent

• Minors < 18 years of age

• Subjects unable to lie flat for the examination

Study Design

N/A

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	CardioMag Imaging

Country where clinical trial is conducted

United States,