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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01185899
Recruitment Status : Completed
First Posted : August 20, 2010
Last Update Posted : November 20, 2015
BSP Biological Signal Processing Ltd.
Information provided by (Responsible Party):
Ori Galante, Soroka University Medical Center

Brief Summary:
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.

Condition or disease
Acute Coronary Syndrome STEMI NSTEMI Unstable Angina Chest Pain

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.

Study Type : Observational
Actual Enrollment : 324 participants
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
Study Start Date : August 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ori Galante, Co-PI, Soroka University Medical Center Identifier: NCT01185899     History of Changes
Other Study ID Numbers: sor505310ctil
First Posted: August 20, 2010    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 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