Premier Heart's MCG system is founded on the principles of
evidence-based medicine. As such, we believe that the best way of
demonstrating the accuracy and capabilities of our technogy is through
well designed double-blind clinical trials coupled with ongoing
analysis and review of our system's performance in daily clinical
practice.
This page presents an overview of our peer-reviewed clinical trial
results. It includes summary data for each trial as well as electronic
copies of the peer-reviewed articles detailing the methods used in
each study.
If you have questions or would like more information on any of the
trials listed below please feel free to
contact us.
MED-FIT Trial (Kawaji et. al.) — Japan
Original Trial Article
Post-Hoc Analysis (Translation)
Letter to the Editor by Drs. Imhoff & Rainford
Author's Response
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This study published in the Annals of noninvasive Electrocardiology
compared MCG analysis to Fractional Flow Reserve (FFR) for purposes
of detecting clnically significant coronary ischemia.
Of note this trial initially indicated poor diagostic
performance due to the use of MCG Severity Score alone.
In the post-hoc analysis (conducted by the original authors
using current guidance for interpretation of MCG reports)
an overall accuracy of 81.3% was achieved, with
sensitivity/specificity of 90.6%/59.3% respectively.
The importance of the session analysis methodology for MCG
and the key differences between anatomical (angiographic)
measurements and functional (MCG, Electrophysiological)
measurements are highlighted in the letter to the editor
reproduced above.
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Results were published online to Wiley Online Library in
Annals of Noninvasive Electrocardiography (2014, 2015) and in Clinical Medicine Vol. 31 No. 1 (January) 2015
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Takeshita et. al. — Japan
Trial Article
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This study compared the results from MCG with
the Classical and Functional SYNTAX scores
of 87 patients.
This study showed a strong correlation between MCG
Severity Score and the Classical / Functional SYNTAX
scores, suggesting that MCG may be useful in identifying
functionally significant ischemia and also in reducing
unnecessary CAGs.
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Results were published online to Wiley Online Library in
Catheterization and Cardiovascular Interventions 00:00-00 (2015)
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Summary Data: Clinical Trials 2000—2004
This summary includes statistical information from our
clinical trials between 2000 and 2004, representing a sample
of over 1,000 patients in three major geographic regions
(North America, Europe and Asia).
All studies in this group were performed in accordance with
Premier Heart's Westchester Study Protocol, utilizing
standard double-blind testing and independent verification
of results.
Overall sensitivity across these studies was 91% (specificity
83.8%, positive predictive value 77.6%, negative predictive
value 92.4%).
Meta Analysis Article - Published in the International Journal of Medical Sciences 2009; 6(4) pp 143-144.
The trials below were conducted with our first generation 3DMP and 3DMP/mfEMT software suite — MCG shares the underlying diagnostic technology and produces identical results.
Westchester Medical Center — New York, USA
Trial Article
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This study compared the results from MCG with
the results of coronary angiograms in a random sample
of 136 patients.
This study showed a sensitivity of 93.3%
(specificity 83%, positive predictive value 91.2%,
negative predictive value 86.7%).
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Results were published in Heart Disease
2002; 4: pp 2-12.
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Siegburg Heart Center — Siegburg, Germany
Two studies were performed at the Siegburg heart
center in Siegburg, Germany, evaluating MCG in patient
populations with and without a history of revascularization.
Trial Article
Monitor Letter
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The first study evaluated the use of MCG in a
set of 423 patients with no prior history of coronary
revascularization.
In this study our technology showed a
sensitivity of 89.1% (specificity 81.1%, positive
predictive value 79%, negative predictive value 90%).
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Results were published in International Journal of Medical Sciences 2007 4(5): pp 249-263.
Trial Article
Monitor Letter
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The second study evaluated the ability of our
technology to deal with the special challenges of
patients with a prior history of coronary
revascularization, testng in a sample of 172 patients.
In this study our technology showed a
sensitivity of 90.9% (specificity 88%, positive
predictive value 62.7%, negative predictive value
97.8%).
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Results were published in International Journal of Medical Sciences 2008 5(2): pp 50-61.
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Asian Multicenter — Four sites
Trial Article
Monitor Letter
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This study was conducted across four centers in Asia
with a sample of 189 patients (including patients
with and without a history of prior revascularization).
This study yielded a sensitivity of 94.8%
(specificity 86.6%, positive predictive value 78.4%,
negative predictive value 97.1%).
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Results were published in Congestive Heart Failure 2008 14: pp. 251-260
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