Test Patient #1


ID:111111 Name:Test Patient #1 Gender:F Client ID:11111 Age:19


Privacy Notice:

This document contains proprietary and confidential material which is legally privileged. The contents of this document may not be disclosed or distributed without the consent of Premier Heart, LLC, or of the patient whose records are contained herein.


Test Patient #2


ID:222222 Name:Test Patient #2 Gender:M Client ID:22222 Age:97


Privacy Notice:

This document contains proprietary and confidential material which is legally privileged. The contents of this document may not be disclosed or distributed without the consent of Premier Heart, LLC, or of the patient whose records are contained herein.



MCG Test Results


Test ID Date ECG Quality Local Ischemia Global Ischemia
3095297 2007-05-07 16:25:01 Good None None
 

Disclaimer:

Clinical studies have shown that MCG™ has a sensitivity of 90+% with 7±2% false negative results and a specificity of 85+% with 15±3% false positive results in detecting ischemia due to coronary artery disease (CAD). A positive CAD ischemia result does not guarantee that the subject has the disease, and a negative CAD ischemia result does not guarantee that the subject does not have the disease.

MCG™ analysis has the following detection rates for coronary arterial plaque luminal encroachment levels:

40-50% encroachment 75% detection rate
50-70% encroachment 90% detection rate
>70% encroachment 96% detection rate

MCG™ assumes that the subject has normal or corrected serum electrolyte chemistry and complete blood count (CBC). It also assumes that the subject has no structural anomalies of the myocardium. If these laboratory test results are unknown, dated, or abnormal at the time of this test, the results may be skewed.

1Local Ischemia: regional or patchy myocardial ischemia caused by mid- or distal single or double vessel coronary artery disease (CAD).
2Global ischemia: diffuse myocardial ischemia caused by proximal large vessel (usually two vessel or more are pathological) CAD, and/or microvascular disease affecting the entire myocardium.



MCG Test Results


Test ID Date ECG Quality Local Ischemia Global Ischemia
3061249 2007-05-03 18:10:15 Marginal None Very severe
 

Disclaimer:

Clinical studies have shown that MCG™ has a sensitivity of 90+% with 7±2% false negative results and a specificity of 85+% with 15±3% false positive results in detecting ischemia due to coronary artery disease (CAD). A positive CAD ischemia result does not guarantee that the subject has the disease, and a negative CAD ischemia result does not guarantee that the subject does not have the disease.

MCG™ analysis has the following detection rates for coronary arterial plaque luminal encroachment levels:

40-50% encroachment 75% detection rate
50-70% encroachment 90% detection rate
>70% encroachment 96% detection rate

MCG™ assumes that the subject has normal or corrected serum electrolyte chemistry and complete blood count (CBC). It also assumes that the subject has no structural anomalies of the myocardium. If these laboratory test results are unknown, dated, or abnormal at the time of this test, the results may be skewed.

1Local Ischemia: regional or patchy myocardial ischemia caused by mid- or distal single or double vessel coronary artery disease (CAD).
2Global ischemia: diffuse myocardial ischemia caused by proximal large vessel (usually two vessel or more are pathological) CAD, and/or microvascular disease affecting the entire myocardium.



Suggestions


Disease severity:

TestMCG Score
3095297 2007-05-07 16:25:01 0 : none

MCG Score Range:
0 = x No disease burden
0 < x <= 2 Mild disease burden
2 < x <= 4 Moderate disease burden
4 < x <= 5.5 Level 1 severe (moderately severe)
5.5 < x <= 7.5 Level 2 severe (severe)
7.5 < x <= 15 Level 3 severe (very severe)
15 < x Level 4 severe (extremely severe)

Secondary results (pathological conditions):

Myocardial Damage
Ventricular Hypertrophy
Cardiomyopathy
Pulmonary Heart Disease
Fibrillation (likely atrial).
Ventricular arrhythmia.
Myocarditis or Myocardial Inflammation
Rheumatic Heart Disease or remnants thereof
Congenital Heart Disease or remnants thereof

Tertiary results (physiopathological conditions):

Myocardial remodeling.
Decreased myocardial compliance. Likely causes include ischemia, ventricular hypertrophy, increased afterload, systemic hypertension.
Increased myocardial compliance. Likely causes include ischemia, myocarditis, structural anomalies, cardiomyopathy.
Decreased cardiac output reflected by decreased ejection fraction.
Bradycardia
Tachycardia
Acute Power Failure. Likely conditions are ischemia heart disease, pump failure, supply and demand imbalance.
Global asynchrony
Regional or localized asynchrony

Disclaimer: This section contains comments and suggested diagnoses or conditions which require rigorous clinical validation. These suggestions and comments should be considered expert opinions and not a definitive diagnosis.



Suggestions


Disease severity:

TestMCG Score
3061249 2007-05-03 18:10:15 9 : very severe

MCG Score Range:
0 = x No disease burden
0 < x <= 2 Mild disease burden
2 < x <= 4 Moderate disease burden
4 < x <= 5.5 Level 1 severe (moderately severe)
5.5 < x <= 7.5 Level 2 severe (severe)
7.5 < x <= 15 Level 3 severe (very severe)
15 < x Level 4 severe (extremely severe)

Secondary results (pathological conditions):

Myocardial Damage
Ventricular Hypertrophy
Cardiomyopathy
Pulmonary Heart Disease
Fibrillation (likely atrial).
Ventricular arrhythmia.
Myocarditis or Myocardial Inflammation
Rheumatic Heart Disease or remnants thereof
Congenital Heart Disease or remnants thereof

Tertiary results (physiopathological conditions):

Myocardial remodeling.
Decreased myocardial compliance. Likely causes include ischemia, ventricular hypertrophy, increased afterload, systemic hypertension.
Increased myocardial compliance. Likely causes include ischemia, myocarditis, structural anomalies, cardiomyopathy.
Decreased cardiac output reflected by decreased ejection fraction.
Bradycardia
Tachycardia
Acute Power Failure. Likely conditions are ischemia heart disease, pump failure, supply and demand imbalance.
Global asynchrony (lead II behind lead V5).
Regional or localized asynchrony

Disclaimer: This section contains comments and suggested diagnoses or conditions which require rigorous clinical validation. These suggestions and comments should be considered expert opinions and not a definitive diagnosis.
 


Auto Power Spectrum of Lead V5


SIL69418 (test: 2007-05-07 16:25:01)
1/2 O U1 U2 U3 U3xy U4 N1 N3 S SS F FF A1 A2 A3 A4 A5 A55
- - - - - - - - - - - - - - - - - - -



 


 



Auto Power Spectrum of Lead V5


SIL30016 (test: 2007-05-03 18:10:15)
1/2 O U1 U2 U3 U3xy U4 N1 N3 S SS F FF A1 A2 A3 A4 A5 A55
- - - - - - - - + + - - - - - - - - -

Legend

N3: Low third and/or fourth peak. Similar to N1 but historical.
S: Bradycardia; S: <60 bpm.




Auto Power Spectrum of Lead II


SIL69418 (test: 2007-05-07 16:25:01)
1/2 O U1 U2 U3 U3xy U4 N1 N3 S SS F FF A1 A2 A3 A4 A5 A55
- - - - - - - - - - - - - - - - - - -



 


 



Auto Power Spectrum of Lead II


SIL30016 (test: 2007-05-03 18:10:15)
1/2 O U1 U2 U3 U3xy U4 N1 N3 S SS F FF A1 A2 A3 A4 A5 A55
- - - - - - - + + + - - - - - - - - -

Legend

N1: Low first peak: recent damage to the mesocardium from general anesthesia, myocardial contusion, syncope, and/or dyspnea leading to hypoxia.
N3: Low third and/or fourth peak. Similar to N1 but historical.
S: Bradycardia; S: <60 bpm.




Coherence Function


SIL69418 (test: 2007-05-07 16:25:01)
Q1 Q2
- -



 


 




Coherence Function


SIL30016 (test: 2007-05-03 18:10:15)
Q1 Q2
+ +
Notes: Decreased ejection fraction.

Legend

Q1: A low first peak.
Q2: Low coherence of the transfer function.




Transfer Function


SIL69418 (test: 2007-05-07 16:25:01)




Transfer Function


SIL30016 (test: 2007-05-03 18:10:15)




Phase Angle Shift


SIL69418 (test: 2007-05-07 16:25:01)
P+ P- WW PWW+ PWW- L
- - - - - -



 


 


 



Phase Angle Shift


SIL30016 (test: 2007-05-03 18:10:15)
P+ P- WW PWW+ PWW- L
- + + - - -
Notes: Myocardial remodeling.Global asynchrony: Lead II behind Lead V5.

Legend

P-: Low phase shift under the abscissa.
WW: A sharp oscillation of phase shift wave forms; usually reflects time delay between different myocardial fibers within a part of the heart due to coronary artery blockage and MI.




Impulse Response Function


SIL69418 (test: 2007-05-07 16:25:01)
D1 D2 f M1 M3 M2 M4
- - - - - - -



 


 

 



Impulse Response Function


SIL30016 (test: 2007-05-03 18:10:15)
D1 D2 f M1 M3 M2 M4
- + - - + - -
Notes: Myocardial remodeling.Increased myocardial compliance.

Legend

D2: Trapezoid wave; current or potential arrhythmia.
M3: Three or more main peaks. Usually reflects a conduction block, atrial/ventricular dilation or increased compliance.




Cross Correlation


SIL69418 (test: 2007-05-07 16:25:01)
rrr RRR r R rr RR rR R+ R- RW+ RW- pt PT Rn
- - + - - - - - - - - - - -

Legend

r: Individual difference without clinical meaning.



 




Cross Correlation


SIL30016 (test: 2007-05-03 18:10:15)
rrr RRR r R rr RR rR R+ R- RW+ RW- pt PT Rn
+ - - - - + - - - - - + + -

Legend

rrr: A low main peak; low cross correlation due to ischemia or potential MI.
RR: Long R-R interval; possible current or potential arrhythmia.
pt: Neuroendocrine disturbance; pt along with 1/2, A5 or A55 suggest CAD.
PT: Neuroendocrine disturbance; PT along with 1/2, A5 or A55 suggest CAD.




Amplitude Histogram V5


SIL69418 (test: 2007-05-07 16:25:01)
V+ V- Vn+ Vn-
- + - +

Legend

V-: Low (<5mm) R waves or hypovoltage in lead V5.
Vn-: Small number of recorded events in the histogram; reflects chronic heart dysfunction for > one year.




Amplitude Histogram V5


SIL30016 (test: 2007-05-03 18:10:15)
V+ V- Vn+ Vn-
- + - +

Legend

V-: Low (<5mm) R waves or hypovoltage in lead V5.
Vn-: Small number of recorded events in the histogram; reflects chronic heart dysfunction for > one year.




Amplitude Histogram II


SIL69418 (test: 2007-05-07 16:25:01)
2+ 2- 2n+ 2n-
- + - -

Legend

2-: Low (<5mm) R waves or hypovoltage in lead II.




Amplitude Histogram II


SIL30016 (test: 2007-05-03 18:10:15)
2+ 2- 2n+ 2n-
- + - +

Legend

2-: Low (<5mm) R waves or hypovoltage in lead II.
2n-: Similar to but carries less impact than a postive Vn-.




ECG Trace: Test 3095297


Lead II




Lead V5






ECG Trace: Test 3061249


Lead II




Lead V5






About MCG™


MCG™ is a new, web-based, non-invasive diagnostic tool for aiding your physician(s) in diagnosing multiple types of heart disease, including coronary artery disease (CAD). It adopts the principles of Systems Analysis in mathematically analyzing the digitized resting electrocardiograph (ECG) data from leads V5 and II simultaneously.


The results of the mathematical calculations are graphically represented as an auto power spectrum and its variations: phase shift, impulse response, coherence function, cross correlation and amplitude histogram. Collectively, these mathematical transformations supply various aspects of the electromechanical properties of the heart muscle in relationship to the physiological properties of the blood and its impact on the myocardial functions as a whole.


The abnormal "Ischemia Indexes" derived from each of these six functions are integrated into a mathematical pattern which represents the myocardium as a whole system which is used for complex pattern recognition. The computer statistically matches each individual's transformation set to the patterns of a large population consisting of thousands of healthy people and tens of thousands of people with heart diseases collected from years of clinical research, software development, and database collections. The computer analysis is then reported to a physician who determines the final diagnosis and therapeutic recommendations, if required.


According to our peer reviewed published (and as yet other unpublished) prospective and double blind trial data from over 1,200 patients undergoing coronary angiograms:

  • Among those who have more than 40% but less than 50% coronary artery atherosclerotic plaque lumenal encroachments in single or multiple vessels, MCG™ detection rates at approximately 75%
  • Among those who have more than 50% but less than 70% coronary artery atherosclerotic plaque lumenal encroachments in single or multiple vessels, MCG™ detection rates at approximately 90%
  • Among those who have more then 70% coronary artery atherosclerotic plaque lumenal encroachments in single or multiple vessels, MCG™ detection rates at approximately 96%
  • There are roughly 15(3)% false positive cases which include:
    1. Coronary artery vasospasms; Coronary Arteriopathy (connective tissue disorders, vaculitides or aneurysms)
    2. Microvascular disease (peripheral vascular disease)
    3. Aortic stenosis/regurgitation
    4. Hypertensive heart disease and metabolic disorders
    5. Renal disease, (i.e. end stage renal disease)
    6. Poor quality ECG tracings
  • There are about 7(2)% false negative cases which include:
    1. Well-established coronary collateral circulations with visibly poor coronary angiogram results
    2. Coronary angiogram results showed moderate lumenal encroachments, however, the MCG™ test was negative.
    3. Poor quality ECG tracings


Finally, unlike the primary diagnosis of the presence or absence of local or global ischemia, the secondary findings of each test (such as MI, LVH, arrhythmias, etc) should be considered as a reference or an expert's opinions rather than definitive diagnosis. This is due to these findings requiring additional controlled, prospective and double blind studies for validations. The ultimate treatment decisions are between you and your physician(s).


For more details on MCG™ analysis, please visit http://www.premierheart.com/webapp/tech.php .



About MCG™


MCG™ is a new, web-based, non-invasive diagnostic tool for aiding your physician(s) in diagnosing multiple types of heart disease, including coronary artery disease (CAD). It adopts the principles of Systems Analysis in mathematically analyzing the digitized resting electrocardiograph (ECG) data from leads V5 and II simultaneously.


The results of the mathematical calculations are graphically represented as an auto power spectrum and its variations: phase shift, impulse response, coherence function, cross correlation and amplitude histogram. Collectively, these mathematical transformations supply various aspects of the electromechanical properties of the heart muscle in relationship to the physiological properties of the blood and its impact on the myocardial functions as a whole.


The abnormal "Ischemia Indexes" derived from each of these six functions are integrated into a mathematical pattern which represents the myocardium as a whole system which is used for complex pattern recognition. The computer statistically matches each individual's transformation set to the patterns of a large population consisting of thousands of healthy people and tens of thousands of people with heart diseases collected from years of clinical research, software development, and database collections. The computer analysis is then reported to a physician who determines the final diagnosis and therapeutic recommendations, if required.


According to our peer reviewed published (and as yet other unpublished) prospective and double blind trial data from over 1,200 patients undergoing coronary angiograms:

  • Among those who have more than 40% but less than 50% coronary artery atherosclerotic plaque lumenal encroachments in single or multiple vessels, MCG™ detection rates at approximately 75%
  • Among those who have more than 50% but less than 70% coronary artery atherosclerotic plaque lumenal encroachments in single or multiple vessels, MCG™ detection rates at approximately 90%
  • Among those who have more then 70% coronary artery atherosclerotic plaque lumenal encroachments in single or multiple vessels, MCG™ detection rates at approximately 96%
  • There are roughly 15(3)% false positive cases which include:
    1. Coronary artery vasospasms; Coronary Arteriopathy (connective tissue disorders, vaculitides or aneurysms)
    2. Microvascular disease (peripheral vascular disease)
    3. Aortic stenosis/regurgitation
    4. Hypertensive heart disease and metabolic disorders
    5. Renal disease, (i.e. end stage renal disease)
    6. Poor quality ECG tracings
  • There are about 7(2)% false negative cases which include:
    1. Well-established coronary collateral circulations with visibly poor coronary angiogram results
    2. Coronary angiogram results showed moderate lumenal encroachments, however, the MCG™ test was negative.
    3. Poor quality ECG tracings


Finally, unlike the primary diagnosis of the presence or absence of local or global ischemia, the secondary findings of each test (such as MI, LVH, arrhythmias, etc) should be considered as a reference or an expert's opinions rather than definitive diagnosis. This is due to these findings requiring additional controlled, prospective and double blind studies for validations. The ultimate treatment decisions are between you and your physician(s).


For more details on MCG™ analysis, please visit http://www.premierheart.com/webapp/tech.php .