Ignite Creation Date:
2024-05-05 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 9:38 AM
Study NCT ID:
NCT00574561
Status:
WITHDRAWN
Last Update Posted:
2009-11-17
First Post:
2007-12-14
Brief Title:
Magnetocardiography MCG in Subjects Undergoing CT Angiography CTA
Sponsor:
Cedars-Sinai Medical Center
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
Magnetocardiography MCG in Subjects Undergoing CT Angiography CTA
Status:
WITHDRAWN
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
sponsor funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 Earths 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 hearts electrical currents It is awaiting FDA approval for the specific diagnosis of ischemia in chest pain patients 23
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 45 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 p00001 The sensitivity specificity PPV and NPV was 871 857 643 and 957 respectively In comparison the diagnostic value of the stress SPECT imaging was 913 750 750 and 913 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
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 hearts electrical currents It is awaiting FDA approval for the specific diagnosis of ischemia in chest pain patients 23
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 45 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 p00001 The sensitivity specificity PPV and NPV was 871 857 643 and 957 respectively In comparison the diagnostic value of the stress SPECT imaging was 913 750 750 and 913 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None