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This MCG™ technology has already earned ISO approval and FDA 510K clearance. The Multifunction Cardiogram has undergone multiple clinical trials verifying its accuracy and has been used to test patients in 8 countries over 3 continents. MCG™ is the 2017 winner of the American Heart Association’s Heart Science Forum’s Innovative Challenge Award.
The following peer-reviewed studies do not include a focus on the MCG™, but provide large-scale clinical evidence for the need of appropriate, accurate technology for risk-stratifying patients who present with chest pain and heart disease symptoms to the hospital ER.
The MCG™ system from Premier Heart, LLC and Heart Care Corp. is founded on the principles of evidence-based medicine.
Heart Care Corp. and Premier Heart, LLC 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 the peer-reviewed articles detailing the methods used in each study.
The MYocardial Health Evaluation and Registry Trial (MYHEART) program’s goal is 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 establishing 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.
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 will perform a continuing 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 has enrolled 3,000+ patients, is correlating MCG™ scores and 30-day patient outcomes, and is double blinded so that the physicians will not know the MCG™ score and will treat the patients with their hospital current protocol. The outcomes data from this trial will continue to accumulate beyond the designated trial period.
In addition to Orlando Heath System, the following institutions participated in this clinical trial:
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.
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.
Forty-five 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.
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).
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.
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.
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).
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).
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).
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