Clinical Studies and Prsentations
Evaluation of noninvasive mathematical analysis of spectral ECG comparing to
Coronary Angiography for severe Ischemic Heart Disease in Emerging Country
Presented at the ACC(American College of Cardiology )Conference Asia in December 2018.
Method：30 patients with MCG (≥ 4 score) scheduled to do CAG were enrolled and compared the MCG results with the CAG results (75%-100% stenosis were positive). Coronary Stenosis by CAG of ≥75% is defined as severe CAD.
Result: MCG scores in patients with or without severe IHD are significantly different. (with IHD:7.0, without IHD:5.4 , p<0.01) Best cut off value of MCG is ≥ 6, and is identified Sensitivity 76.5%, Specificity 69.2%, PPV 76.5%, NPV 69.2%, and Accuracy 73.3% (p<0.05).
Conclusion: MCG showed high sensitivity and specificity, and high score of MCG ≥6 likely indicates the presence of severe IHD.
Clinical Implication: We suggest that MCG could be used for prompt detection of severe IHD in order to start appropriate Treatments (Percutaneous Coronary Intervention/Optimal Medical Therapy/CABG) in the emerging countries such as Myanmar where less medical facilities and skills are available.
If CAD is caught early by MCG test, ACS can be highly preventable in Myanmar by Doing MCG Test
Study of Japan Myanmar Medical Help Group(JMMHG). Presented at the 26th Japanese Association of Cardiovascular Intervention and Therapeutics(CVIT) in Kyoto(2017)
Method：20 patients with MCG (≥ 4 score) scheduled to do CAG were selected. Coronary Stenosis by CAG of ≥75% is defined as severe CAD.
Result: MCG scores in patients with or without severe CAD are significantly different. (with CAD: 6.5, without CAD:4.9, p<0.001) . Best cut off value is MCG score ≥ 6, and is identified sensitivity 80.0% and specificity 90.0%, PPV 88.9%, NPV81.8%, and accuracy 85.0% (p<0.01).
Conclusion: MCG showed high sensitivity and specificity, and high score of MCG likely indicates the presence of severe CAD. MCG can be used for early detection and follow-up of CAD same as diagnosed by CAG
Diagnostic Performance of Multifunction Cardiogram for Low Risk Patients with Coronary Artery Disease
Study of Aichi Medical College. Presented at the 81th JCS Annual Scientific Meeting(2017)
Method： For 102 patients performed CTA compare CA score, SSS(Segment Stenosis Score) and SIS(Segment Involvement Score) with MCG..
Result/Discussion(1)MCG scores are significantly different patients between normal and with severe stenosis.(normal:0.5 vs with stenosis: 3.5, p<0.001)(2) For ROC curve detecting severe stenosis, (AUC=0.75、Sensitivity: 60.0%, Specificity: 86.6%, PPV:52.2%, NPV:89.9%, Best cutoff:3.5、P<0.001)(3)SSS and MCG, SIS and MCG are correlated.(SSS:r=0.30、p=0.002, SIS:0.26, p=0.009). MCG score is correlated to severe stenosis and the study demonstrated MCG might provide a valuable contribution to the diagnosis of CAD in a non-invasive manner.
Introduction of MCG, the examination for detecting ischemic heart disease
Study by Bell Clinic and presented at the 57th Japan Human Doc Society(2016).
Method：62 examinee was classified as MCG positive or negative group, and ECG positive and negative group. The result of each groups were compared with the risk factors of IHD such as age, family history smoking habit, Max/Min blood pressure, BMI, Abdominal circumference, FBS, HbA1c, T-CHO, LDL-C, TG, HDL-C). Also, these groups were compared with the number of risk factors of IHD. Result/Discussion：- Between ECG result and any risk factors of IHD, no significant difference was recognized. Between MCG severity category and risk factors of IHD, significant differences were recognized in age, blood pressure, BMI, abdominal circumference, FBS and HbA1c. Significant difference was also recognized between MCG severity score and the number of risk factors of IHD.
– It is considered that MCG can detect the light damage of myocardium caused by age, obesity, high blood pressure, and diabetes which can’t be detected by ECG.
Effectiveness of MCG predicting recurrence of atrial fibrillation after pulmonary vein isolation: A preliminary result
Study of Aichi Medical College. Presented at the 63th Japanese Heart Rhythm Society(JHRS)(2016)
Method:A total of 76 consecutive patients receiving pulmonary vein isolation were prospectively enrolled. Recurrence of Af（N=13）was defined as within 3 month after pulmonary vein isolation.
Result/Discussion:MCG score was not different between patient with and without recurrence Af. Frequency of “arrhythmic tendency” in the report of MCG after pulmonary vein isolation was significantly higher in Recurrent Af.
・The MCG seems to be useful to predict recurrence of Af after pulmonary vein isolation.
Noninvasive Detection of Coronary Atherosclerosis by Multifunction Cardiogram
Study of Aichi Medical College. Presented at the 80th JCS Annual Scientific Meeting(2016)
Method： For 84 patients performed CTA compare CA score, SSS(Segment Stenosis Score) and SIS(Segment Involvement Score) with MCG..
Result/Discussion(1)MCG scores are significantly different patients between normal and with severe stenosis.(normal:0.5 vs with stenosis: 3.5, p<0.001）(2) For ROC curve detecting severe stenosis, AUC＝0.79, Sensitivity:66.7%, Specificity:86.4%, PPV: 57.1% and NPV:90.5%.(Best cut off point is 3.5, p<0.0001)(3)SSS and MCG, SIS and MCG are correlated.(SSS:r=0.36、p=0.001, SIS:0.31, p=0.004）
Noninvasive Mathematical Analysis of Spectral Electrocardiographic Components for Coronary Lesions of Intermediate to Obstructive Stenosis Severity–Relationship with Classic and Functional SYNTAX Score
Study of Aichi Medical College, Chubu Rosai Hospital, and Nagoya University.
Article of the Journal CCI(*)(Catheterization and Cardiovascular Interventions)
(*)Official Journal of the Society for Cardiovascular Angiography and Interventions in the USA.
Method: For 87 patients performed CAG compare SYNTAX Score (Classic/Functional) and MCG(Low/Border/High), and ECG and FRS.
Result/Discussion: Only MCG correlated with SYNTAX score(Classic SYNTAX score：OR=2.92 [1.60 to 5.31], p<0.001) (Functional SYNTAX score：OR=3.66 [1.95 to 6.87], p<0.001). Spec.:92.6%(classic), 92.3%(functional) and accuracy72.4%(classic), 82.8%(functional).
Conclusion: MCG shows high Spec. and NPV. MCG is useful for not only detecting functional ischemia but also reducing unnecessary CAG.
Non-invasive assessment of functionally significant coronary stenosis by MCG
Study of Aichi Medical College, Chubu Rosai Hospital, and Nagoya University.
Article of the Open Heart(*)(2014)
(*)official journal of British Society of Cardiology by British Medical Journal.
Method: Compare IHD by CAG/FFR to the result of MCG/ECG/Framingham risk score(FRS)(n=100)
Result/Discussion: Only MCG is significantly correlated to the Ischemia level(OR=2.67 (1.60 to 4.44), p<0.001). In Model 1(FFR≤0.8), MCG’s spec. is 90.4% (87.0% to 93.9%).(accuracy:79.0%).MCG shows high specificity and is suggested to be useful to detect not only significant IHD but reduce unnecessary CAG.
Comparison MCG and CAG in Symptomatic Patients
Presentation at ESC(Europe Society of Cardiology)2012.
Method: Test MCG and CAG to 89 patients and compare. Result:45 patients (50.5%) are TP, 31(34.8%) are TN, 12(13.4%) are FP, and 1(1.1%) is FN.(Sens.97.8%、spec.72.0%、PPV:78.9%,NPV:96.8%)
Discussion: Uing cut off point 3.0 and it shows higher sensitivity and lower specificity than old study.(cut off point is 4.0)High accuracy of non invasive MCG can delay CAG safely. Specificity is low however, most of 12 FP shows DM, Hyperglycemia , HT and possible Peripheral vascular disease. 6 patients with >=70% stenosis and well-established collateral shows low MCG score and FN patient takes Vasodilator therapy.
A Paired-Comparison of the MultiFunction CardioGramsm (MCG) and SPECT Myocardial Perfusion Imaging (MPI)
International Journal of Medical Sciences 2011;8(8):717-72
Comparison between MCG and SPECT(2011)
Comparing MCG and Coronary Angiography for detection of Coronary Artery Stenosis in Women
Treatment Strategies – Cardiology Volume 3, Issue 1 pp.82-91
Study summarized for women. Sensitivity is 92.4% and Specificity is 85.3%.
In the article, it is mentioned that the ischemic heart disease of women is increasing. The necessity of early detection and usefulness of MCG are also mentioned.
American College of Cardiology 2011
Presentation at ACC 2011.Study about comparison with Myocardial Perfusion Imaging(MPI) by Dr.John Strobeck.
Comparison MCG and MPI with CAG for 165 patients, and the sensitivity of MCG was 91%, (Spec.:87%, PPV:86%, NPV:92%). It was higher than MPI.
American Academy of Urgent Care Medicine
Conference of American Academy of Urgent Care Medicine 2008.
Video of the discussions about MCG technology and usage in clinical field by Dr. Imhoff, Dr.Strobeck, and Dr.Shen.
An analysis of the effect of age, gender and revascularization on MCG results
Circulation 2007 116: II_367
Presentation at (American Heart Association) 2007.
Based on the 2 studies at Siegburg Heart Center in 2001. Comparison between MCG and CAG for 758 patients. MCG Sensitivity was 89% (Spec.85.6%, PPV:76.6%, NPV:93.7%)
A comparison of the MCG system to coronary angiography
American College of Chest Physicians October 2007 132(4): 466S
Presentation based on the study conducted at Siegburg heartcenter in Germany in 2001. Evaluated the accuracy of MCG for 172 patients who performed PCI. MCG sensitivity to CAG was 90.9%.(Spec.:88%, PPV:62.7%, NPV:97.8%)
(Published in the International Journal of Medical Sciences 2009; 6(4) pp 143-144.)
Meta Analysis of 3 trials conducted from 2000 to 2004. Double blinded clinical trial were performed in USA, Germany, Japan, Korea Singapore and India, for total 1,076 patients.
Sensitivity was 91.2%, (Specificity 84.6%, PPV81.9%, and NPV92.6%) comparing to CAG results.
Asian Multicenter — Four sites
（published in Congestive Heart Failure 2008 14: pp. 251-260 ）
189 patients were selected among Asian 4 countries (Japan, Korea, Singapore, and Indea).Sensitivity was 94.8%, (Specificity 86.6%, PPV78.4%, and NPV97.1%) comparing to CAG results.
Siegburg Heart Center — Siegburg, Germany (First Trial)
（published in International Journal of Medical Sciences 2007 4(5): pp 249-263. ）
1st Trial in Siegburg, Germany. 423 patients who had no PCI history were selected. Sensitivity was 89.1%, (Specificity 81.1%, PPV79%, and NPV90%) comparing to CAG results.
Siegburg Heart Center — Siegburg, Germany (Second Trial)
（published in International Journal of Medical Sciences 2008 5(2): pp 50-61. ）
2nd trial in Germany. 172 patients who did PCI were selected. Sensitivity was 90.9%, (Specificity 88%, PPV 62.7%, and NPV 97.8%) comparing to CAG results.
Westchester Medical Center — New York, USA
1st MCG trial conducted in New York, USA. 138 patients were randomly selected and compared MCG with CAG.
Sensitivity was 93.3%, (Specificity 83%, PPV 91.2%, and NPV 86.7%) comparing to CAG results.