Magnetocardiography (MCG) in Asymptomatic Individuals - Pilot Trial

Cedars-Sinai Medical Center

Status: Withdrawn

Conditions: Healthy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00572442

13939

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 4 patient groups

1

Description:

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

Description:

Subjects with 1 cardiovascular risk factor (listed above)

3

Description:

Subjects with 2 cardiovascular risk factors (listed above)

4

Description:

Subjects with more than 2 cardiovascular risk factors (listed above)