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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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

Other trials in United States

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.

  1. First posted17 Dec 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionDec 2009 (estimated)
  4. Study completionDec 2009 (estimated)

Why it stopped: sponsor funding

Resources

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)
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 15534820
  • Fenici 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 15934809
  • Tolstrup 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 16733351
  • 5)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

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.

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