Chest PainNCT00574561
Magnetocardiography (MCG) in Subjects Undergoing CT Angiography (CTA)
An observational study of Chest Pain, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The investigators wish to study the magnetic field map using magnetocardiography (MCG) in subjects undergoing computed tomographic angiography (visualization of the heart arteries using CT scanning, CTA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing CT angiography to evaluate their coronary arteries for the presece of heart disease.
Who may be able to join
- Subjects undergoing 64-slice CT angiography
Who cannot join
- Hemodynamically unstable patients
- 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 investigators wish to study the magnetic field map using magnetocardiography (MCG) in subjects undergoing computed tomographic angiography (visualization of the heart arteries using CT scanning, CTA). The main purposes is to investigate if MCG is capable of detecting the presence of obstructive coronary artery disease (CAD) as detected by CT angiography (CTA) as well if the MCG can exclude the presence of CAD as defined by CTA.
Secondarily the investigators will look at the correlation of MCG with non-obstructive CAD and the correlation of MCG with other tests (treadmill testing, stress echo or nuclear scan, coronary angiography) done as part of the work up for CAD.
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. 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 (1).
Since then the technology has been greatly improved and several multi-channel 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, Schenectady, New York) 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 by the FDA as a safe tool to measure and record the magnetic field arising from the heart's electrical currents. It is awaiting FDA approval for the specific diagnosis of ischemia in chest pain patients (2,3).
We have been using the CMI 9-channel MCG for detection of ischemia in patients admitted to Cedars-Sinai Medical Center for acute chest pain syndrome. The results are very exciting and have been published in abstracts and one manuscript, with another manuscript in submission (4,5). In summary, we studied 75 patients with acute chest pain and 65 healthy volunteers and found a very strong association with an abnormal MCG scan and ischemia (p<0.0001). The sensitivity, specificity, PPV and NPV was 87.1%, 85.7%, 64.3%, and 95.7%, respectively. In comparison, the diagnostic value of the stress SPECT imaging was 91.3%, 75.0%, 75.0%, and 91.3%, for sensitivity, specificity, positive and negative predictive value, respectively. These results were achieved without the use of stress provocation, contrast administration, or any ionizing radiation, and the results were available immediately.
Since starting the chest pain protocol another diagnostic imaging technology has become more widespread used, 64-slice CT angiography. This technology utilizes a fast CT scanner and involves administration of a contrast agent, but avoids the invasiveness of a heart catheterization. The accuracy of detection of CAD and its exclusion is very high as compared with angiography (6). Although minimally invasive, the CT angiogram does involve a radiation dose similar to that used with stress nuclear testing, approximately 900 to 1100 mrem (6) and the iodine contrast used may cause contrast nephropathy, especially in diabetics and those with already impaired renal function. The use of this technology provides an opportunity to find subjects with normal coronary arteries with accuracy close to as high as for invasive coronary angiography. To date, this population has been hard to study, since subjects with a normal stress test rarely will undergo more invasive studies.
Therefore, we wish to conduct this correlative study with CT angiography and the entirely noninvasive and risk free MCG to see if we in the future may be able to avoid some of the risks associated with CTA. We think that we may find that subjects with a clearly abnormal MCG may not need CTA, but could proceed directly to angiography and possible angioplasty.
- Conditions
- Chest Pain
- Keywords
- CT angiography (CTA), Magnetocardiography (MCG), heart disease
- Medical subject headings
- Chest Pain, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startJul 2007
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 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
- NCT00574561
- Sponsor's protocol ID
- 10057
- Status last verified
- Nov 2009
- First submitted
- 14 Dec 2007
- Last updated
- 17 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
1)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.
Koch H. Recent advances in magnetocardiography. J Electrocardiol. 2004;37 Suppl:117-22. doi: 10.1016/j.jelectrocard.2004.08.035.
PubMed 15534820Fenici R, Brisinda D, Meloni AM. Clinical application of magnetocardiography. Expert Rev Mol Diagn. 2005 May;5(3):291-313. doi: 10.1586/14737159.5.3.291.
PubMed 15934809Tolstrup K, Madsen BE, Ruiz JA, Greenwood SD, Camacho J, Siegel RJ, Gertzen HC, Park JW, Smars PA. Non-invasive resting magnetocardiographic imaging for the rapid detection of ischemia in subjects presenting with chest pain. Cardiology. 2006;106(4):270-6. doi: 10.1159/000093490. Epub 2006 May 29.
PubMed 167333515)Kirsten Tolstrup, Donatella Brisinda, Anna M. Meloni, Brian Cheung, Sean Rashti, Robert J. Siegel, Riccardo Fenici. Resting Magnetocardiography is Highly Accurate for the Detection of Ischemia in Patients with Acute Chest Pain Syndrome. Submitted.
Stein PD, Beemath A, Kayali F, Skaf E, Sanchez J, Olson RE. Multidetector computed tomography for the diagnosis of coronary artery disease: a systematic review. Am J Med. 2006 Mar;119(3):203-16. doi: 10.1016/j.amjmed.2005.06.071.
PubMed 16490463
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 Subjects Undergoing CT Angiography (CTA)
- ClinicalTrials.gov ID
- NCT00574561
- Acronym / sponsor ID
- 10057
- Conditions
- Chest Pain
- Keywords
- CT angiography (CTA), Magnetocardiography (MCG), heart disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: sponsor funding
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- CardioMag Imaging
- Study start
- Jul 2007
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 17 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 investigators wish to study the magnetic field map using magnetocardiography (MCG) in subjects undergoing computed tomographic angiography (visualization of the heart arteries using CT scanning, CTA). The main purposes is to investigate if MCG is capable of detecting the presence of obstructive coronary artery disease (CAD) as detected by CT angiography (CTA) as well if the MCG can exclude the presence of CAD as defined by CTA.
Secondarily the investigators will look at the correlation of MCG with non-obstructive CAD and the correlation of MCG with other tests (treadmill testing, stress echo or nuclear scan, coronary angiography) done as part of the work up for CAD.
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. 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 (1).
Since then the technology has been greatly improved and several multi-channel 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, Schenectady, New York) 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 by the FDA as a safe tool to measure and record the magnetic field arising from the heart's electrical currents. It is awaiting FDA approval for the specific diagnosis of ischemia in chest pain patients (2,3).
We have been using the CMI 9-channel MCG for detection of ischemia in patients admitted to Cedars-Sinai Medical Center for acute chest pain syndrome. The results are very exciting and have been published in abstracts and one manuscript, with another manuscript in submission (4,5). In summary, we studied 75 patients with acute chest pain and 65 healthy volunteers and found a very strong association with an abnormal MCG scan and ischemia (p<0.0001). The sensitivity, specificity, PPV and NPV was 87.1%, 85.7%, 64.3%, and 95.7%, respectively. In comparison, the diagnostic value of the stress SPECT imaging was 91.3%, 75.0%, 75.0%, and 91.3%, for sensitivity, specificity, positive and negative predictive value, respectively. These results were achieved without the use of stress provocation, contrast administration, or any ionizing radiation, and the results were available immediately.
Since starting the chest pain protocol another diagnostic imaging technology has become more widespread used, 64-slice CT angiography. This technology utilizes a fast CT scanner and involves administration of a contrast agent, but avoids the invasiveness of a heart catheterization. The accuracy of detection of CAD and its exclusion is very high as compared with angiography (6). Although minimally invasive, the CT angiogram does involve a radiation dose similar to that used with stress nuclear testing, approximately 900 to 1100 mrem (6) and the iodine contrast used may cause contrast nephropathy, especially in diabetics and those with already impaired renal function. The use of this technology provides an opportunity to find subjects with normal coronary arteries with accuracy close to as high as for invasive coronary angiography. To date, this population has been hard to study, since subjects with a normal stress test rarely will undergo more invasive studies.
Therefore, we wish to conduct this correlative study with CT angiography and the entirely noninvasive and risk free MCG to see if we in the future may be able to avoid some of the risks associated with CTA. We think that we may find that subjects with a clearly abnormal MCG may not need CTA, but could proceed directly to angiography and possible angioplasty.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing CT angiography to evaluate their coronary arteries for the presece of heart disease.
Key inclusion criteria (1 listed)
- Subjects undergoing 64-slice CT angiography
Key exclusion criteria (4 listed)
- Hemodynamically unstable patients
- Patients with pacemakers or internal defibrillators
- Minors < 18 years of age
- Patients unable to lie flat for the examination
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)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.
- Background: PubMed 15534820Koch H. Recent advances in magnetocardiography. J Electrocardiol. 2004;37 Suppl:117-22. doi: 10.1016/j.jelectrocard.2004.08.035.
- Background: PubMed 15934809Fenici R, Brisinda D, Meloni AM. Clinical application of magnetocardiography. Expert Rev Mol Diagn. 2005 May;5(3):291-313. doi: 10.1586/14737159.5.3.291.
- Background: PubMed 16733351Tolstrup K, Madsen BE, Ruiz JA, Greenwood SD, Camacho J, Siegel RJ, Gertzen HC, Park JW, Smars PA. Non-invasive resting magnetocardiographic imaging for the rapid detection of ischemia in subjects presenting with chest pain. Cardiology. 2006;106(4):270-6. doi: 10.1159/000093490. Epub 2006 May 29.
- Background5)Kirsten Tolstrup, Donatella Brisinda, Anna M. Meloni, Brian Cheung, Sean Rashti, Robert J. Siegel, Riccardo Fenici. Resting Magnetocardiography is Highly Accurate for the Detection of Ischemia in Patients with Acute Chest Pain Syndrome. Submitted.
- Background: PubMed 16490463Stein PD, Beemath A, Kayali F, Skaf E, Sanchez J, Olson RE. Multidetector computed tomography for the diagnosis of coronary artery disease: a systematic review. Am J Med. 2006 Mar;119(3):203-16. doi: 10.1016/j.amjmed.2005.06.071.
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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 4 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 NCT00574561, 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.