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

Acute Coronary Syndrome Clinical Trial

Official title:

The Usefulness of High-frequency QRS Analysis in the Evaluation of Patients Presenting to the Emergency Department With Chest Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185899
• Other study ID #: sor505310ctil
• Status: Completed
• Phase: N/A
• First received: August 18, 2010
• Last updated: November 18, 2015
• Start date: August 2010
• Est. completion date: August 2013

Study information

• Verified date: November 2015
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Unstable
• Chest Pain
• NSTEMI
• STEMI
• Unstable Angina

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Beer Sheva

Sponsors (2)

Lead Sponsor	Collaborator
Ori Galante	BSP Biological Signal Processing Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnosis or rule-out of acute coronary syndrome	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.	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	No