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Usefulness of High-frequency QRS Analysis in the Evaluation of Patients With Chest Pain

This study has been completed.
BSP Biological Signal Processing Ltd.
Information provided by (Responsible Party):
Ori Galante, Soroka University Medical Center Identifier:
First received: August 18, 2010
Last updated: November 18, 2015
Last verified: November 2015
Accurate detection of a heart attack (an acute myocardial infarction) is one of the most pressing needs in medicine. Recordings of the electrocardiogram (ECG) (electrical activity of the heart) are one of the first tools used to diagnose a heart attack, but the ECG is not very accurate, especially at the beginning of a heart attack. A new technique for analysing a special part of the ECG may provide more accurate detection of a heart attack. The study hypothesis is that this new technique, the HFQRS analysis, will provide important additional information to that available from the regular ECG.

Acute Coronary Syndrome STEMI NSTEMI Unstable Angina Chest Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Usefulness of High-frequency QRS Analysis in the Evaluation of Patients Presenting to the Emergency Department With Chest Pain

Resource links provided by NLM:

Further study details as provided by Ori Galante, Soroka University Medical Center:

Primary Outcome Measures:
  • diagnosis or rule-out of acute coronary syndrome [ Time Frame: diagnosis or rule-out of ACS will be determined at two time points: 1) upon diacharge when discharge diagnosis is determined. Follow up information will be obtained one month post discharge ]
    The primary end-point of the study is definite discharge diagnosis or rule-out of acute coronary syndrome, based on cardiac biomarkers, ECG changes, clinical symptoms and cardiac imaging tests.

Enrollment: 324
Study Start Date: August 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Suspected ACS patients
Patients presenting with chest pain to the Emergency Department, who are suspected of having ACS, will be asked to participate in the study.

Detailed Description:

Chest pain is one of the leading reasons for hospital emergency department (ED) visits worldwide. In the United States (US), over 6 million people annually undergo evaluation in the ED for acute chest pain. Despite the wealth of knowledge available about acute coronary syndrome (ACS), this condition continues to be among the most difficult to predict or diagnose. Nearly half of patients hospitalized for unstable angina eventually receive a non-cardiac-related diagnosis. Nonetheless, 2-8% of patients with myocardial infarction (MI) are inappropriately discharged from the ED and mortality rates among patients with an MI who were mistakenly sent home are disproportionately higher (25-33%) than those among patients who were admitted.

Although the ECG is a mainstay in the management of suspected ACS, it has major limitations in both sensitivity and specificity for diagnosis of ACS. The initial 12-lead ECG in the ED is often non-diagnostic in ACS patients, especially in non-ST elevation MI (NSTEMI) and unstable angina (UA), and therefore cannot rule-out ischemia or infarction. Elevation in serum biomarkers is usually not detectable for 4-6 hours after an MI, and some patients do not show a biomarker elevation for as long as 12 hours. Consequently, new clinical tools for early risk stratification of patients with acute chest pain are being sought.

Conventional analysis of ST segment deviations aims to detect repolarization abnormalities. However, ischemia may also bring about changes in the depolarization phase of the electrical cardiac cycle. These depolarization changes can be detected and quantified using analysis of the high-frequency components of the QRS complex (HFQRS). HFQRS analysis has been previously reported to be a sensitive method for detection of demand ischemia during exercise testing. Preliminary studies have shown that HFQRS-derived indices can also identify supply ischemia caused by prolonged balloon occlusion, and transient ischemic episodes in patients with chest pain.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients arriving to the emergency department of Soroka University Medical Center with chest pain that is suspected of being due to acute coronary syndrome

Inclusion Criteria:

  • Patients with chest pain, suspected to have ACS
  • Duration of chest pain greater than 20 minutes
  • Time from onset of chest pain less than 12h
  • Signed an informed consent

Exclusion Criteria:

  • History of trauma or any other evident medical cause of chest pain
  • Prior coronary artery bypass graft
  • Pre-excitation syndrome (example WPW)
  • Atrial Fibrillation or significant ventricular arrhythmia
  • Bundle branch block, intraventricular conduction delay or
  • QRS duration greater than 120 ms
  • Implanted pacemaker or defibrillator
  • Patients who received fibrinolytic therapy, glycoprotein IIb or IIIa inhibitors before the initial ECG recording
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01185899

Soroka University Medical Center
Beer Sheva, Israel, 84101
Sponsors and Collaborators
Ori Galante
BSP Biological Signal Processing Ltd.
Principal Investigator: Doron Zahger, MD Soroka University Medical Center
  More Information

Responsible Party: Ori Galante, Co-PI, Soroka University Medical Center Identifier: NCT01185899     History of Changes
Other Study ID Numbers: sor505310ctil
Study First Received: August 18, 2010
Last Updated: November 18, 2015

Keywords provided by Ori Galante, Soroka University Medical Center:
heart attack
acute myocardial infarction
Unstable Angina
suspected acute coronary syndrome
Non-ischemic chest pain

Additional relevant MeSH terms:
Acute Coronary Syndrome
Chest Pain
Angina, Unstable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Angina Pectoris processed this record on September 21, 2017