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Clinical Trials

The MCG system is licensed from Premier Heart to Emergency MCG and is founded on the principles of evidence-based medicine.

Emergency MCG and Premier Heart believe that the best way to demonstrate the accuracy and capabilities of the MCG technology is through well-designed double-blind clinical trials coupled with ongoing analysis and review of the MCG system’s performance in daily clinical practice.

The following presents an overview of peer-reviewed clinical trial results covering the MCG system. It includes summary data for each trial as well as electronic copies of peer-reviewed articles detailing the methods used in each study.

MyHEART Clinical Data Registry (2019-2024)

The Myocardial Health Evaluation And Registry Trial (MYHEART) program aims to build a clinical database of approximately 2,000,000 patients (Medicare patients and patients age 40+) across the U.S. over three years. The purpose of the trial is to demonstrate that the MCG as an effective screening tool for heart disease and to document the efficacy of lifestyle medicine in reversing the effects of coronary artery disease.  Additional objectives include introducing and studying the MCG in primary care settings and to establish a major applied outcomes database, which will be made available to independent academic researchers.  This program is expected to recruit more than 200 U.S. primary care practices, healthcare networks, and hospital organizations who serve the U.S. primary care market.  The MyHEART trial is expected to conclude by 2024, and is structured to provide an additional revenue source for participating care organizations.

U.S  Emergency Room Outcomes Trial (2016-2019)

Emergency MCG USA Inc. has developed a multi-center phase IV clinical trial with Orlando Health System in conjunction with the University of Central Florida Medical School whereby they are performing an outcome study to find the MCG score that correlates to a 99.5% Negative Predictive Value which would allow them to discharge ER patients home without fear that they will suffer a major adverse coronary event (MACE) within the following thirty (30) day period. This trial will enroll 3,000 patients, will correlate MCG scores and 30-day patient outcomes, and will be double-blinded so that the physicians will not know the MCG score and will treat the patients with their hospital current protocol. The trial is scheduled to conclude in early 2019.

In addition to Orlando Heath System, the following institutions are participating in this clinical trial:

  • Tampa General Hospital and The University of South Florida Medical School

  • Jackson Memorial Hospital in Miami and The University of Miami Medical School

  • Soon to be added: Shands UF Health Hospital and the University of Florida Medical School

 

ACEP Abstract publication

Aichi Atrial Fibrillation Study (2016)

A clinical trial led by the Aichi Medical University (Nagakute, Japan) is currently underway to examine the ability of the Multifunction Cardiogram to predict the recurrence of atrial fibrillation after pulmonary vein isolation procedures.  A total of 39 consecutive patients receiving pulmonary vein isolation were enrolled.  Recurrence of Af (N=6) was defined as within 3 months after pulmonary vein isolation.  Preliminary results show that frequency of MCG reported “arrhythmic tendency” after pulmonary vein isolation was significantly higher in recurrent Af, and that the MCG appears to be a useful predictor of Af after pulmonary vein isolation.

Preliminary Presentation of Results (Abstract)

Japanese Restenosis Trial (2015)

A multi-center clinical trial including Aichi Medical University, Chubu Rosai Hospital, and the Nagoya University Graduate School of Medicine studied the impact of noninvasive mathematical analysis of spectral electrocardiographic components on the prediction of recurrent cardiac ischemic events after coronary intervention. 45 consecutive patients who underwent coronary intervention were enrolled and analyzed using the Multifunction Cardiogram to study its effectiveness as a predictor of recurrent cardiac ischemic events.  The initial conclusions indicated that the MCG may be a useful predictor of recurrent ischemic events after coronary intervention, especially in patients who are not able to exercise and have low kidney function.

Preliminary Presentation of Results (Abstract)

Summary Data: Clinical Trials 2000—2004

This summary includes statistical information from clinical trials between 2000 and 2004, representing a sample of more than 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 percent (specificity 83.8 percent, positive predictive value 77.6 percent, negative predictive value 92.4 percent).

Meta-Analysis Article – Published in the International Journal of Medical Sciences 2009; 6(4) pp 143-144.

http://www.premierheart.com/webapp/downloads/Articles/IJMS_2009_04.pdf

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

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%).
Results were published in Heart Disease 2002; 4: pp 2-12.

http://www.premierheart.com/webapp/downloads/clinical_trials/Westchester-2000.pdf

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.

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 percent (specificity 81.1 percent, positive predictive value 79 percent, negative predictive value 90 percent).

Monitor letter: http://www.premierheart.com/webapp/downloads/clinical_trials/Monitoring_Siegburg-2003.pdf

Results were published in the International Journal of Medical Sciences 2007 4(5): pp 249-263.
http://www.premierheart.com/webapp/downloads/clinical_trials/Siegburg-2003-norevasc.pdf

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 a sample of 172 patients. In this study, our technology showed a sensitivity of 90.9 percent (specificity 88 percent, positive predictive value 62.7 percent, negative predictive value 97.8 percent).

Monitor letter: http://www.premierheart.com/webapp/downloads/clinical_trials/Monitoring_Siegburg-2003.pdf

Results were published in the International Journal of Medical Sciences 2008 5(2): pp 50-61.
http://www.premierheart.com/webapp/downloads/clinical_trials/Siegburg-2003-revasc.pdf

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 percent (specificity 86.6 percent, positive predictive value 78.4 percent, negative predictive value 97.1 percent).

Monitor letter: http://www.premierheart.com/webapp/downloads/clinical_trials/Monitoring_Asia-2004.pdf

Results were published in Congestive Heart Failure 2008 14: pp. 251-260


http://www.premierheart.com/webapp/downloads/clinical_trials/Asia-2004.pdf

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