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Magnetocardiography (MCG) in Asymptomatic Individuals - Pilot Trial

This study has been withdrawn prior to enrollment.
(sponsor funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00572442
First Posted: December 13, 2007
Last Update Posted: November 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
CardioMag Imaging
Information provided by:
Cedars-Sinai Medical Center
December 12, 2007
December 13, 2007
November 17, 2009
December 2007
November 2009   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00572442 on ClinicalTrials.gov Archive Site
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Magnetocardiography (MCG) in Asymptomatic Individuals - Pilot Trial
Magnetocardiography (MCG) in Asymptomatic Individuals - Pilot Trial

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.

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.

Observational
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Non-Probability Sample
individuals without symptoms or history of heart disease
Healthy
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  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
40
December 2009
November 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00572442
13939
No
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Not Provided
Kirsten Tolstrup, MD, Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
CardioMag Imaging
Principal Investigator: Kirsten Tolstrup, MD Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
November 2009