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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This study has been withdrawn prior to enrollment.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

December 12, 2007
November 16, 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)
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*   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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00572442
13939
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP