Clinical Trials
LSW MEDICAL LLC
         "Accelerating Diagnosis through Innovation "
The 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 technology 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.
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).
Overall sensitivity across these studies was 91% (specificity 83.8%, positive predictive value 77.6%, negative predictive value 92.4%).
The component studies were:

Westchester Medical Center — New York, USA
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%).
Siegburg Heart Center — Siegburg, Germany
Two studies were performed at the Siegburg heart center.

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%).
The second study evaluated the ability of our technology to deal with the special challenges of patients with a prior history of coronary revascularization, testing 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%).
Asian Multicenter — Four sites

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%).
Pre-Revascularization (Study 1)Computerized two-lead resting ECG analysis for the detection of coronary artery stenosis
Post-Revascularization (Study 2)
Computerized two-lead resting ECG analysis for the detection of coronary artery stenosis after coronary revascularization
Computer-Enhanced Frequency-
Domain and 12-Lead
Electrocardiography Accurately
Detect Abnormalities Consistent With
Obstructive and Nonobstructive
Coronary Artery Disease
Computerized 2-Lead Resting ECG Analysis for the Detection of Relevant Coronary Artery Stenosis in Comparison With Angiographic Findings
Westchester-2000.pdf
Westchester-2000.pdf
Siegburg-2003-norevasc.pdf
Siegburg-2003-norevasc.pdf
Siegburg-2003-revasc.pdf
Siegburg-2003-revasc.pdf
Asia-2004.pdf
Asia-2004.pdf
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