HealthyNCT00572442
Magnetocardiography (MCG) in Asymptomatic Individuals - Pilot Trial
An observational study of Healthy, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: individuals without symptoms or history of heart disease
Who may be able to join
- Subjects without chest pain and known heart diseases.
- Subjects > or = 18 years of age.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
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.
Read the 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.
- Conditions
- Healthy
- Keywords
- Non-invasive heart scan, MCG, Cardiac Risk Factors, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionNov 2009 (estimated)
- Study completionDec 2009 (estimated)
Why it stopped: sponsor funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- CardioMag Imaging
- Investigators
- Kirsten Tolstrup, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572442
- Sponsor's protocol ID
- 13939
- Status last verified
- Nov 2009
- First submitted
- 12 Dec 2007
- Last updated
- 17 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetocardiography (MCG) in Asymptomatic Individuals - Pilot Trial
- ClinicalTrials.gov ID
- NCT00572442
- Acronym / sponsor ID
- 13939
- Conditions
- Healthy
- Keywords
- Non-invasive heart scan, MCG, Cardiac Risk Factors, healthy volunteers
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: sponsor funding
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- CardioMag Imaging
- Study start
- Dec 2007
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 13 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- individuals without symptoms or history of heart disease
Key inclusion criteria (2 listed)
- Subjects without chest pain and known heart diseases.
- Subjects > or = 18 years of age.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Tolstrup, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2009.