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Multifunction CardioGramTM (MCGTM) is the world's first Internet based non-invasive diagnostic tool that adopts Applied Systems Engineering prinicpals using Digital Signal Processing, i.e. DSP, Data-mining and Supervised Machine Learning to aid physicians to make rapid and much more accurate diagnosis of heart diseases. It is an FDA and AMA approved to diagnose myocardial ischemia due to Coronary Artery Disease (CAD). MCG extracts resting ECG data between the two electrical cources (leads V5 and II) to measure the interactions between Myocardium and intra-cardiac blood flow to accurately detect CAD without the stress, radiation, chemicals and invasiveness of the current modality set. This ground breaking Computational Systems Biology technology that will fundamentally change how heart disease is diagnosed. It is the culmination of the efforts of two generations of dedicated scientists, mathematicians, engineers and physicians over the course of three decades. MCG uses rapid, automated, cloud-based DSP applications, empirically derived digitized clinical database, and machine learning tools through the internet to give people around the world the access to the most accurate diagnostic system ever created, directly from primary care providers' offices or a patient's home, bypassing the need for costly and inaccurate imaging technologies currently in use in cardiologists' offices. We created MCG Technology to solve an intractable problem in cardiology: the extreme and unacceptable inaccuracies of the traditional EKG. EKG can only detect approximately 1/3 (one third) of patients with severe coronary artery disease, leaving them in danger of dying from their undetected illness. The problem is even worse for women, leading in part to more women dying from heart disease than men. The time has come for a much needed, radical change that MCG represents, delivering 5 - 8 times more accurate diagnosis than traditional EKGs. In addition, a double-blind and perspective clinical validation trial comparing MCG with the current gold-standard imaging tool – nuclear myocardial perfusion scan (MPI), using coronary angiogram results as the final judge, MCG was twice as accurate as MPI! (Strobeck, Mangieri, Rainford, Imhoff J. Am. Coll. Cardiol.) == Function == The MCG test consists of an 82 second test where leads II and V5 resting cardiac electrical signals are collected, digitized, encrypted and sent to Premier Heart's data center. The data is then analyzed and transformed into multiple mathematical functions. These mathematical models produce a matrix based on 166 different indices that are then compared against a database of more than 40,000 patients with a broad range of clinically verified myocardial ischemia. A summarized report is returned to the physician via internet connection to the MCG unit in less than 10 minutes. Performance of an MCG Test: A Four Step Process MCG is performed in the following four steps. Step 1: Multiple cycles of complete resting ECG analog signals from leads II and V5 are recorded by a portable device from a patient at the point of care. The recorded signals are then digitized, encrypted and securely transmitted along with the patient’s demographic information to a central data center for processing. Step 2: The computers at the central data center perform a Fast-Fourier-Transformation of the signals from each lead, preparing them for a series of additional mathematical transformations. Research over the last three decades has demonstrated that these mathematical functions are able to extract physiological information embedded in between the two left ventricular leads, II and V5. Step 3: MCG mathematically transforms the complex non-linear information obtained in Step 2. The mathematical transformations employed include multiple non-linear mathematical functions such as auto and cross power spectra, cross-correlation, coherence, impulse-response and phase shift. These functions produce 166 indices. The index patterns from an individual patient are compared to similar patterns obtained from people whose MCG data has been entered into a large empirical database. This database consists of over 27,000 people with CAD, whose CAD status and severity is included in the database and has been confirmed by coronary angiography. Importantly, the database also contains MCG results from many patients who have one or more non-ischemic cardiac diseases. Therefore, the database is used to distinguish MCG patterns in patients with cardiac ischemia from MCG patterns in patients with non-ischemic cardiac disease and those with both cardiac ischemia and non-ischemic cardiac disease(s). Approximately 13,000 of the patients in the database have had normal coronary angiograms or have been determined to not have CAD after independent evaluations by two cardiologists. The database has been carefully accumulated over many years, and the MCG patterns of each entrant have been validated and correlated with the presence (or absence) and severity of CAD. The database has been designed to be robust and to minimize bias by including, among other things, 49% of its data from women and an age range of 14-100 in the CAD and non-CAD groups, as well as people with many forms of heart disease (e.g., arrhythmias, hypertrophy, cardiomyopathy), in addition to CAD. The database also contains other clinical and diagnostic data from all 40,000+ patients, including information about other non-cardiac disease entities. Step 4: Based on the comparison to the reference database, an overall ischemia severity score (ranging from 0 to 20) is reported. (See Exhibit 4 for an overview of the MCG process). Clinical Application MCG data has been used to predict the findings of coronary angiography in several carefully designed and well-conducted prospective double-blind validation clinical trials (Grube 2007, Grube 2008, Weiss 2002, Hosokawa 2008, which are included as Exhibits 5, 6, 7 and 8, respectively). These trials were conducted in seven countries and three continents (North America, Asia and Europe). In these studies, MCG was performed on patients who were scheduled for elective coronary angiography by cardiologists who, on the basis of clinical impression and standard non-invasive testing, believed that the patients had an intermediate to high risk of having relevant coronary artery stenosis (CAS). Relevant CAS was defined as a 70% or greater stenosis of one or more major epicardial arteries or a 50% or greater occlusion of the left main coronary artery. The patients in these trials represent "real-world" care, much like the patients studied by Patel. In this regard, it is not surprising that the percentage of patients who were found to have relevant CAS in each of these trials was similar to the percentage who had relevant CAS in the Patel study. This means that even though the treating cardiologists believed that some patients in these four trials were at high risk for significant CAD, the patients studied in these trials were, in reality, at intermediate risk of having significant heart disease rather than at high risk. Therefore, these trial results are directly applicable to most patients seen with suspected CAD. These four trials of MCG were designed to compare the accuracy of MCG versus the accuracy of the standard of care (i.e., clinical impression coupled with standard noninvasive testing) in predicting the existence of relevant CAS. This direct comparison to predict the findings of coronary angiography – the gold standard test - has never, to our knowledge, been published in the medical literature from 1949 to the present. The studies were all similarly designed as follows: • 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Multifunction cardiogram」の詳細全文を読む スポンサード リンク
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