Technology

Overview

The Multifunction Cardiogram™ (MCG) is a revolutionary new kind of diagnostic tool for measuring the health of a patient’s heart and the impact of ischemia and other problems. MCG™ detects and measures myocardial ischemia with unprecedented accuracy in minutes. The MCG™ unit is a light weight, portable, and durable device that uses diagnostic leads to capture resting ECG data at the point of care by trained technical staff. The test is administered non-invasively, without the use of chemicals or radiation and without causing dangerous stress to the patient. With the help of the MCG™, physicians are able to make much more rapid, objective, and accurate diagnoses of heart diseases.

The MCG™ uses a systems approach to modeling the heart and then comparing these models to a demographically appropriate risk-stratified database of similar patients using 166 indices with that database to aid both in the diagnosis and in predicting patient needs and outcomes.

The MCG™ was created to solve an intractable problem in cardiology: the unacceptable inaccuracies of the EKG and other cardiac-related diagnostic tools and the need for more accurate tools. The inaccuracy of the present diagnostic tools affects both patients with cardiac issues as well as patients whose symptoms may appear to be cardiac-related but are not actually cardiac-derived. An EKG can detect approximately 1/3 of patients with severe coronary artery disease, leaving 2/3 of the patients in danger of dying from their undetected illness. Patients showing signs and symptoms of cardiac-related conditions are often catheterized and have angiograms performed. However, 62 percent of these patients actually have no significant atherosclerosis.

Due to the inability of the current modalities to detect microvascular heart disease, the problem created by inaccurate cardiac diagnostic tools is even more acute for women, leading in part to more women suffering longer term from heart disease than men.

The MCG™ is the culmination of the efforts of two generations of dedicated scientists, mathematicians, engineers, and physicians. It uses rapid, automated, cloud-based, empirically derived digitized clinical databases to give doctors around the world the access to a startlingly accurate diagnostic system.

Dr. Bruce Feldman, M.D., Chief Medical Officer, ADIG

How it Works

Premier Heart’s MCG™ System represents a radical departure from traditional resting and stress ECG techniques — Where medicine has historically taken a reductionistic view of the ECG, Premier Heart’s MCG™ technology uses an integrative approach, building a mathematical model of the entire cardiac system. This approach allows MCG™ to obtain accurate diagnoses from a simple, non-invasive test.

Premier Heart’s system consists of three stages:

  • First, the medical provider collects resting ECG data from the patient. This process is similar to a standard resting ECG and can be performed quickly and easily in nearly any setting. The ECG data is transmitted to Premier Heart’s data center via an encrypted internet connection.
  • Once received at Premier Heart’s data center, the MCG™ diagnostic system takes over, running a series of mathematical transformations on the raw ECG data to identify distinct functional indices. These indices are compared to our clinically validated database and a numeric MCG™ Score is assigned to represent the severity of cardiac disease burden observed during the test. In addition to the MCG™ Score, the system also provides a set of differential diagnoses for specific conditions contributing to the result, giving the treating physician guidelines for additional evaluation and treatment.
  • The MCG™ Score and identified conditions are compiled into an easy-to-read report which the physician can review on the MCG™ unit, or any computer with a web browser. These reports can provide guidance when developing a treatment plan or in referring a patient to a cardiologist for follow-up testing. Sample reports for normal and abnormal patients are available.
Sample Reports
Technical Whitepaper

How it Compares

When compared to other diagnostic modalities, MCG™ is exceptionally accurate and reliable, surpassing most established clinical techniques in both sensitivity and specificity. In addition, MCG™ is capable of accurately detecting coronary artery disease at earlier stages (<70% lumen encroachment), exceeding the capabilities of other techniques and allowing earlier intervention at stages where coronary artery disease may be controlled by lifestyle changes or medication.

Comparison Chart
Premier Heart

Peer-Reviewed Publications

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.

Clinical Trials

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.

MyHEART Clinical Data Registry (2019-2022)

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.

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 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:

  • 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
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.

Aichi AF Study
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. 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.

PCI TCT San Francisco
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).

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

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.

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).

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).

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).

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