Magnetocardiography (MCG) in Asymptomatic Individuals - Pilot Trial

November 16, 2009 updated by: Cedars-Sinai Medical Center

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.

Study Overview

Status

Withdrawn

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

individuals without symptoms or history of heart disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
1

Subjects without any cardiovascular risk factors:

  1. Age ≥ 45 in men; Age ≥ 55 in women.
  2. Hypertension: BP > 140/90 mmHg or on BP meds.
  3. Diabetes Mellitus: Known fasting blood sugar >126 mg/dl or on DM meds.
  4. Dyslipidemia: On lipid lowering medication or LDL ≥ 160 mg/dl in absence of other risk factors; ≥ 130 mg/dl if other non-diabetic risk factors; ≥ 100 mg/dl if diabetic. Known HDL < 40 mg/dl.
  5. Cigarette smoking (past or present).
  6. Family history of premature CAD in first degree relatives: Age < 55 in men; Age < 65 in women.
2
Subjects with 1 cardiovascular risk factor (listed above)
3
Subjects with 2 cardiovascular risk factors (listed above)
4
Subjects with more than 2 cardiovascular risk factors (listed above)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Collaborators

CardioMag Imaging

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Anticipated)

November 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

December 12, 2007

First Submitted That Met QC Criteria

December 12, 2007

First Posted (Estimate)

December 13, 2007

Study Record Updates

Last Update Posted (Estimate)

November 17, 2009

Last Update Submitted That Met QC Criteria

November 16, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13939

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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