Chest PainNCT00572949
Magnetocardiography (MCG) in the Diagnosis of Chest Pain Syndrome
An observational study of Chest Pain, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate a better way of diagnosing heart artery disease, heart attack and damage to the heart muscle early on. Currently, it often takes several hours after admission before lab tests will show that there has been any damage to the heart muscle. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chest Pain
- How many people
- 398 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to 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: Patients with chest pain syndrome
Who may be able to join
- Patients with chest pain syndrome
Who cannot join
- ST elevation MI
- Hemodynamically unstable patients
- Tachycardia with heart rate >150 just prior to testing or at time of testing
- A-V Dissociation on 12-lead ECG
- Patients with pacemakers or internal defibrillators
- Minors < 18 years of age
- Patients 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 evaluate a better way of diagnosing heart artery disease, heart attack and damage to the heart muscle early on. Currently, it often takes several hours after admission before lab tests will show that there has been any damage to the heart muscle. Although the standard electrocardiogram is quick and non-painful it may miss many cases of significant coronary heart disease. The investigators are proposing that a new entirely non-contact tool, the Magnetocardiograph (MCG), with high accuracy is able to predict the presence of significant coronary heart disease early on before other studies become positive. The investigators hope by this that the investigators can develop an algorithm for better triage and management of patients with chest pain.
This research study is designed to test the effectiveness of the investigational use of the Magnetocardiograph (MCG) that has been approved by the U.S Food and Drug Administration (FDA). While the MCG used in the study is FDA-approved as a tool for the non-contact measurement and display of the magnetic fields of the heart generated by the electrical currents, it is not yet approved for the specific diagnosis of heart artery disease (ischemia).
Read the detailed description
Cardiomagnetism refers to the detection, analysis and interpretation of the magnetic fields generated by the electrical activity of the heart. The peak value of the magnetic fields of the heart is more than a million times smaller than the Earth's magnetic field. A major breakthrough in the capability of measuring such small fields came with the invention of the SQUID (superconducting quantum interference device) in the late sixties. The first magnetocardiograms (MCGs) measured with the SQUID were recorded by Cohen et al. in 1970 (1). These earlier measurements were performed in very expensive magnetically shielded rooms, initially utilizing only one or two SQUID probes. In the eighties this technology was tested in several laboratories creating a magnetic field map by moving one SQUID sequentially above the chest to create an image of the whole hearts magnetic field. These maps were then attempted correlated with various pathologies (2,3).
Since then the technology has been greatly improved and several multichannel machines are in use across the world for research purpose for arrhythmia localization and ischemia detection. However, at present time, only one company (CardioMag Imaging) has developed a machine that operates outside a shielded room.
The CardiomagImaging (CMI) Magnetocardiograph (MCG) is capable of noninvasive recording of magnetic fields arising from the electrical activity of the heart with very high spatial and temporal resolution. The temporal trace of the MCG is analogous to an ECG, and, similarly, can be recorded in multiple leads. This MCG device has been specifically developed for the general purpose (outside shielded room) of non-contact, non-invasive diagnostics of ischemia.
The CMI MCG device has been approved as safe for patients. It is FDA approved for the noninvasive detection and display of the heart's magnetic field created by the electrical currents, and is awaiting FDA approval for the detection of ischemia in chest pain patients. A similar SQUID technology utilized in magnetically shielded rooms has already been FDA approved for localization of epileptic focus. When utilized in this matter it is referred to as MEG (magnetoencephalogram).
Several abstracts have been presented primarily at meetings on Biomagnetism, that confirm the safety and indicate the efficacy of the MCG for the detection of ischemia. In particular, it has been suggested that the resting MCG is capable of detecting ischemia in patients with chest pain, when the 12-leads ECG is normal (4,5,6). However, this has not been tested in larger prospective blinded studies.
Cedars-Sinai Medical Center Non-invasive Cardiac Laboratory will be the first center in the US evaluating the CardioMag Imaging MCG in a clinical environment for the detection of ischemia in an acute coronary syndrome patient population. Patients will be enrolled in a similar protocol at Johns Hopkins Medical Center, Baltimore, Mayo clinic, Rochester, and at Klinikum Hoyerswerda, Germany. The early detection of ischemia (before Troponins become positive) with high negative and positive predictive values may prove cost effective and decrease risk by improving prompt treatment and triage to higher or lower grade monitoring at time of hospitalization.
- Conditions
- Chest Pain
- Keywords
- heart disease, chest pain, coronary artery disease, atherosclerosis
- Medical subject headings
- Chest Pain, Heart Diseases, Coronary Artery Disease, Atherosclerosis
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 | Patients with chest pain syndrome |
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 startOct 2004
- Primary completionDec 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.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 398 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
- NCT00572949
- Sponsor's protocol ID
- 4039
- Status last verified
- Nov 2009
- First submitted
- 12 Dec 2007
- Last updated
- 17 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
1) Cohen D, Edelsack EA, Zimmerman JE. Magnetocardiograms taken inside a shielded room with a superconducting point-contact magnetometer. Appl. Phys. Lett. 1970, 16, 278-280.
Nakaya Y, Sumi M, Saito K, Fujino K, Murakami M, Mori H. Analysis of current source of the heart using isomagnetic and vector arrow maps. Jpn Heart J. 1984 Sep;25(5):701-11. doi: 10.1536/ihj.25.701.
PubMed 62399323) Stroink G, MacAuley C, Montague TJ, Horacek BM. Normal and abnormal components in magnetocardiographic maps of a subject with myocardial infarction. Med. Biol. Eng. Comp. 1985, 23, 61-62.
4) Brazdeikis A, Taylor AA, Mahmarian JJ, Xue Y, Chu CW. Comparison of magnetocardiograms acquired in unshielded clinical environment at rest, during and after exercise and in conjunction with myocardial perfusion imaging. Biomag 2002, 530-532.
5) Chaikovsky I, Primin M, Nedayvoda I, Vassylyev V, Sosnitsky V, Steinberg F. Computerized classification of patients with coronary artery disease but normal or unspecifically changed ECG and healthy volunteers. Biomag 2002, 534-536.
Morguet AJ, Behrens S, Kosch O, Lange C, Zabel M, Selbig D, Munz DL, Schultheiss HP, Koch H. Myocardial viability evaluation using magnetocardiography in patients with coronary artery disease. Coron Artery Dis. 2004 May;15(3):155-62. doi: 10.1097/00019501-200405000-00004.
PubMed 15096996
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 the Diagnosis of Chest Pain Syndrome
- ClinicalTrials.gov ID
- NCT00572949
- Acronym / sponsor ID
- 4039
- Conditions
- Chest Pain
- Keywords
- heart disease, chest pain, coronary artery disease, atherosclerosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: sponsor funding
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- CardioMag Imaging
- Study start
- Oct 2004
- Primary completion
- Dec 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 evaluate a better way of diagnosing heart artery disease, heart attack and damage to the heart muscle early on. Currently, it often takes several hours after admission before lab tests will show that there has been any damage to the heart muscle. Although the standard electrocardiogram is quick and non-painful it may miss many cases of significant coronary heart disease. The investigators are proposing that a new entirely non-contact tool, the Magnetocardiograph (MCG), with high accuracy is able to predict the presence of significant coronary heart disease early on before other studies become positive. The investigators hope by this that the investigators can develop an algorithm for better triage and management of patients with chest pain.
This research study is designed to test the effectiveness of the investigational use of the Magnetocardiograph (MCG) that has been approved by the U.S Food and Drug Administration (FDA). While the MCG used in the study is FDA-approved as a tool for the non-contact measurement and display of the magnetic fields of the heart generated by the electrical currents, it is not yet approved for the specific diagnosis of heart artery disease (ischemia).
Detailed description
Cardiomagnetism refers to the detection, analysis and interpretation of the magnetic fields generated by the electrical activity of the heart. The peak value of the magnetic fields of the heart is more than a million times smaller than the Earth's magnetic field. A major breakthrough in the capability of measuring such small fields came with the invention of the SQUID (superconducting quantum interference device) in the late sixties. The first magnetocardiograms (MCGs) measured with the SQUID were recorded by Cohen et al. in 1970 (1). These earlier measurements were performed in very expensive magnetically shielded rooms, initially utilizing only one or two SQUID probes. In the eighties this technology was tested in several laboratories creating a magnetic field map by moving one SQUID sequentially above the chest to create an image of the whole hearts magnetic field. These maps were then attempted correlated with various pathologies (2,3).
Since then the technology has been greatly improved and several multichannel machines are in use across the world for research purpose for arrhythmia localization and ischemia detection. However, at present time, only one company (CardioMag Imaging) has developed a machine that operates outside a shielded room.
The CardiomagImaging (CMI) Magnetocardiograph (MCG) is capable of noninvasive recording of magnetic fields arising from the electrical activity of the heart with very high spatial and temporal resolution. The temporal trace of the MCG is analogous to an ECG, and, similarly, can be recorded in multiple leads. This MCG device has been specifically developed for the general purpose (outside shielded room) of non-contact, non-invasive diagnostics of ischemia.
The CMI MCG device has been approved as safe for patients. It is FDA approved for the noninvasive detection and display of the heart's magnetic field created by the electrical currents, and is awaiting FDA approval for the detection of ischemia in chest pain patients. A similar SQUID technology utilized in magnetically shielded rooms has already been FDA approved for localization of epileptic focus. When utilized in this matter it is referred to as MEG (magnetoencephalogram).
Several abstracts have been presented primarily at meetings on Biomagnetism, that confirm the safety and indicate the efficacy of the MCG for the detection of ischemia. In particular, it has been suggested that the resting MCG is capable of detecting ischemia in patients with chest pain, when the 12-leads ECG is normal (4,5,6). However, this has not been tested in larger prospective blinded studies.
Cedars-Sinai Medical Center Non-invasive Cardiac Laboratory will be the first center in the US evaluating the CardioMag Imaging MCG in a clinical environment for the detection of ischemia in an acute coronary syndrome patient population. Patients will be enrolled in a similar protocol at Johns Hopkins Medical Center, Baltimore, Mayo clinic, Rochester, and at Klinikum Hoyerswerda, Germany. The early detection of ischemia (before Troponins become positive) with high negative and positive predictive values may prove cost effective and decrease risk by improving prompt treatment and triage to higher or lower grade monitoring at time of hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with chest pain syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chest pain syndrome
Key inclusion criteria (1 listed)
- Patients with chest pain syndrome
Key exclusion criteria (7 listed)
- ST elevation MI
- Hemodynamically unstable patients
- Tachycardia with heart rate >150 just prior to testing or at time of testing
- A-V Dissociation on 12-lead ECG
- Patients with pacemakers or internal defibrillators
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.
- Background1) Cohen D, Edelsack EA, Zimmerman JE. Magnetocardiograms taken inside a shielded room with a superconducting point-contact magnetometer. Appl. Phys. Lett. 1970, 16, 278-280.
- Background: PubMed 6239932Nakaya Y, Sumi M, Saito K, Fujino K, Murakami M, Mori H. Analysis of current source of the heart using isomagnetic and vector arrow maps. Jpn Heart J. 1984 Sep;25(5):701-11. doi: 10.1536/ihj.25.701.
- Background3) Stroink G, MacAuley C, Montague TJ, Horacek BM. Normal and abnormal components in magnetocardiographic maps of a subject with myocardial infarction. Med. Biol. Eng. Comp. 1985, 23, 61-62.
- Background4) Brazdeikis A, Taylor AA, Mahmarian JJ, Xue Y, Chu CW. Comparison of magnetocardiograms acquired in unshielded clinical environment at rest, during and after exercise and in conjunction with myocardial perfusion imaging. Biomag 2002, 530-532.
- Background5) Chaikovsky I, Primin M, Nedayvoda I, Vassylyev V, Sosnitsky V, Steinberg F. Computerized classification of patients with coronary artery disease but normal or unspecifically changed ECG and healthy volunteers. Biomag 2002, 534-536.
- Background: PubMed 15096996Morguet AJ, Behrens S, Kosch O, Lange C, Zabel M, Selbig D, Munz DL, Schultheiss HP, Koch H. Myocardial viability evaluation using magnetocardiography in patients with coronary artery disease. Coron Artery Dis. 2004 May;15(3):155-62. doi: 10.1097/00019501-200405000-00004.
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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 Chest Pain, 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 1 inclusion and 7 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?
On the ClinicalTrials.gov record for NCT00572949, which also lists 6 linked publications.
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.