Project: Early detection and monitoring of myocardial ischemia using analysis of high frequency ECG components

Background and motivation: Myocardial ischemia, resulting from coronary artery disease (CAD), is a major health problem worldwide. Undiagnosed or untreated CAD can ultimately lead to acute myocardial ischemia and infarction, which are life-threatening conditions. Approximately 15 million patients per year in the US and Europe present to the emergency department with chest pain suggestive of acute myocardial infarction (AMI). Accurate, early and low-cost diagnosis or rule-out of acute myocardial ischemia is imperative in order to properly and efficiently triage these patients, establish their diagnosis and initiate appropriate therapy. _x000D_In the patients who actually have an ongoing myocardial infarction, early diagnosis and treatment is critical to reduce morbidity and mortality (“time is muscle”). In the reCOing patients, reliable early rule-out of acute ischemia (unstable angina) may significantly reduce the associated healthcare costs. _x000D__x000D_Conventional techniques for electrocardiographic detection of acute cardiac ischemia commonly rely upon the identification of repolarization abnormalities, manifested as changes in the ST-T segment of the ECG._x000D_However, ischemia can also induce electrocardiographic changes in the depolarization phase, which can be detected and quantified by analyzing the high-frequency QRS components (HFQRS) of the ECG._x000D_HFQRS is a novel technology for accurate detection of myocardial ischemia. HFQRS has been shown to improve the diagnostic accuracy of ECG stress testing, and preliminary studies indicated its potential benefit for identifying and monitoring acute myocardial ischemia._x000D__x000D_Project aims: The principal goal of this project is to develop diagnostic software, embedded in advanced ECG devices that will utilize HFQRS analysis for improved diagnosis and monitoring of myocardial ischemia. _x000D_Specific goals:_x000D_1. Development of diagnostic software for detection of acute myocardial ischemia by HFQRS analysis_x000D_2. Development of diagnostic software for online monitoring of transient ischemia_x000D_3. Integration of HFQRS diagnostic software in a high resolution 16-lead resting ECG and patient monitoring/Holter devices_x000D_4. Assessment of the quality and benefits of HFQRS-based detection of myocardial ischemia in a real clinical setup_x000D__x000D_Project content: the project will consist of three types of work packages: _x000D_1) Acquisition and analysis of clinical data _x000D_2) Development of diagnostic algorithms and software _x000D_3) Integration of the diagnostic software in ECG devices _x000D__x000D_The clinical work, to be conducted at the University Hospital Basel, will be used to collect ECG signals along with clinical information for development and evaluation of the HFQRS diagnostic software. The following studies will be conducted:_x000D_a) Detection or rule-out of acute myocardial ischemia by HFQRS analysis in patients presenting with chest pain_x000D_b) Diagnosis of stable CAD by HFQRS analysis during exercise testing_x000D_c) Prospective clinical evaluations of ECG devices with HFQRS analysis for management of patients presenting with chest pain_x000D__x000D_The data obtained in the acute myocardial ischemia study will be used to attune the HFQRS algorithms and develop diagnostic software for identification of acute myocardial ischemia. The data obtained in the stable CAD study will be used as a control set, enabling to differentiate between stress-induced ischemia and acute ischemia at rest. The serial ECG / monitoring data from the acute myocardial ischemia study will be used to adapt the HFQRS analysis to online operation, enhancing the capabilities of the diagnostic software with detection of transient ischemia._x000D__x000D_The diagnostic software for detection of acute myocardial ischemia will be integrated into Schiller’s 16-lead advanced ECG system, the CS-200 Excellence, providing it ground-breaking capabilities for initial risk stratification of patients presenting with chest pain. The diagnostic software for online monitoring of transient ischemia will be integrated in the CS-200 Excellence and/or 12-lead ECG Holter software, enabling cost-effective observation of patients with suspected unstable angina._x000D__x000D_The project consortium consists of Biological Signal Processing Ltd. from Israel, Schiller AG and the University Hospital of Basel from Switzerland. BSP's CO role will be in the development of diagnostic software . Schiller will integrate the HFQRS diagnostic software into its advanced ECG devices. The University Hospital of Basel will perform all necessary clinical data collection, definition/diagnosis of clinical reference/gold standard and the prospective studies to evaluate the efficacy of the developed diagnostic modules._x000D_

Acronym HFQRS (Reference Number: 5495)
Duration 05/11/2010 - 04/11/2014
Project Topic The principal goal of this project is to develop diagnostic software, embedded in advanced ECG devices that will utilize analysis of high-frequency ECG components for improved diagnosis and monitoring of myocardial ischemia
Project Results
(after finalisation)
The two most important results of the projects are:_x000D_1. The successful implementation of the first generation algorithm of high frequency ECG analysis for diagnosing myocardial ischemia and its integration in advanced ECG devices._x000D_2. The creation of a large database of patients suspected of myocardial ischemia with a gold standard diagnosis that allows further development and validation of more advanced versions of the above algorithm.
Network Eurostars
Call Eurostars Cut-Off 4

Project partner

Number Name Role Country
3 SCHILLER AG Partner Switzerland
3 Biological Signal Processing Ltd. Coordinator Israel
3 University Hospital of Basel Partner Switzerland