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Magnetocardiography (MCG) in Asymptomatic Individuals - Pilot Trial

This study has been withdrawn prior to enrollment.
(sponsor funding)
Sponsor:
Collaborator:
CardioMag Imaging
Information provided by:
Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00572442
First received: December 12, 2007
Last updated: November 16, 2009
Last verified: November 2009
History of Changes
  Purpose

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.


Condition
Healthy

Study Type: Observational
Official Title: Magnetocardiography (MCG) in Asymptomatic Individuals - Pilot Trial

Further study details as provided by Cedars-Sinai Medical Center:

Estimated Enrollment: 40
Study Start Date: December 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

individuals without symptoms or history of heart disease

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572442

Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
CardioMag Imaging
Investigators
Principal Investigator: Kirsten Tolstrup, MD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Kirsten Tolstrup, MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00572442     History of Changes
Other Study ID Numbers: 13939
Study First Received: December 12, 2007
Last Updated: November 16, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Non-invasive heart scan
MCG
Cardiac Risk Factors
healthy volunteers

ClinicalTrials.gov processed this record on May 23, 2013