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Clinical Research

VectraCor has received the support of Key Opinion Leaders (KOL) in the cardiology and acute care fields, and more specifically of the CEB® and derived ECG technology. The Company sought out physicians and researchers to conduct clinical studies and use the VectraplexECG System in their facilities. Some of the participating institutions and the studies that were conducted are outlined below.

Published study comparing the CEB® to high sensitivity troponin blood test/cardiac serum markers. Presented at ACC 2014 in San Francisco, CA. Published in Critical Pathways in Cardiology – Volume 13, Number 1, March 2014

Conclusions: In conclusion, in patients in ED evaluated for acute myocardial injury, increasing values of HsTnI were associated with increasing values of the CEB®, suggesting that myocardial injury is associated with acute changes in the CEB® in the population of patients with high pretest probability of acute myocardial injury.

University of Basel Leading Research Facility Worldwide on Cardiac Serum Markers – Cardiac Electrical Biomarker, a Novel Marker Diagnosing Myocardial Injury in Patients With Symptoms Suggestive for NSTEMI. Presented at the AHA in November 2017 in Orlando, FL (Published in Circulation. 2017;136:A13562)

Conclusion: The CEB®, an ECG marker of myocardial injury, significantly improves the accuracy and sensitivity of the ECG for the diagnosis of NSTEMI.

University of Basel Leading Research Facility Worldwide on Cardiac Serum Markers/High Sensitivity Troponin (Dr. Mueller/Dr. Reichlin).  Published and presented at The European Society of Cardiology Conference in Rome – September 2016.  Abstract has been published, and the full manuscript is done and being submitted to a leading journal.

Conclusion: The CEB®, a novel ECG marker indicating myocardial injury, significantly improves the diagnostic accuracy of the ECG for the diagnosis of AMI.

Prospective study in the Cardiac Cath Lab – Study presented at the American College of Cardiology Conference (ACC) in Washington, DC in March 2017

Conclusions: The CEB® shows a positive response to balloon and stent inflation during PCI with a strong correlation. The CEB® appears to show a stronger response to balloon inflation in larger arteries, cases involving infarction, and in greater severity stenosis. The CEB® may be an efficient and timely means of detecting myocardial ischemia in patients who are being monitored in acute care settings.

Milton Keynes

Cardiac electrical biomarker retains “memory” of myocardial ischemia not severe enough to cause myocardial necrosis. S. Chattopadhyay, F. Adjei, A.Kardos

“Cardiac electrical biomarker” (CEB) is a numerical index measured by Vectraplex ECG (vECG) System with a software able to detect changes of the dipolar vectors in the cardiac electrical field to multipolar as an indicator of myocardial ischemic injury. CEB has been validated with ECG traces derived from patients with acute myocardial infarction.

Conclusion: CEB increases with short repeated transient coronary artery occlusion not severe enough to
cause myocardial necrosis and took 3 hours to return to the pre-procedural level suggesting an
“ischemic memory”.

ESC

Cardiac Electrical Biomarker Improves ECG Prediction of Left Ventricular Scar. Fabrizio Ricci, MD, PhD, Cesare Mantini, MD, PhD, Melissa De Maio, MD, Carla Pietrangelo, MD, Anna Laura Caterino, MD, Luca Procaccini, MD, Marzia Olivieri, MD, Antonella Benedetto, MD, Marco Zimarino, MD, PhD, Giulia Renda, MD, PhD, Antonio Raffaele Cotroneo, MD, Sabina Gallina, MD, FACC, FESC

 Myocardial scar detected by cardiovascular myocardial resonance (CMR) with late gadolinium enhancement (LGE) imaging is associated with increased risk of major adverse cardiovascular events and all-cause mortality.

Conclusion: Non-invasive ECG quantitative assessment of multipolar activity of the heart improves accuracy of conventional 12-lead ECG criteria for prediction of left ventricular ischemic scar. Further research is needed to test whether CEB might serve as a screening tool for the detection of silent myocardial infarction in asymptomatic patients.

 

ATLANTIC HEALTH SYSTEM/SUMMIT MEDICAL GROUP

Published 7 studies/abstracts from Dr. Schreck and Dr. Fishberg – Dr. Schreck has published over 40 abstracts over the past 30 years. Presented abstracts at numerous conferences

(ACC, ACEP, SCCM, ISCE and others)

AHS