NCT00572442

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

November 17, 2009

Status Verified

November 1, 2009

Enrollment Period

1.9 years

First QC Date

December 12, 2007

Last Update Submit

November 16, 2009

Conditions

Healthy

Keywords

Non-invasive heart scanMCGCardiac Risk Factorshealthy volunteers

Study Arms (4)

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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

individuals without symptoms or history of heart disease

You may qualify if:

  • Subjects without chest pain and known heart diseases.
  • Subjects \> or = 18 years of age.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Study Officials

  • Kirsten Tolstrup, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 12, 2007

First Posted

December 13, 2007

Study Start

December 1, 2007

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

November 17, 2009

Record last verified: 2009-11

Locations

US(1)