Feasibility of High Frequency QRS Analysis in Patients With Acute Myocardial Infarction

• Conditions: Myocardial Infarction

• Registration Number: NCT01150825
• Lead Sponsor: BSP Biological Signal Processing Ltd.

Brief Summary

The primary objective of this study is to characterize the morphological patterns of high frequency QRS components (HFQRS) in patients with acute myocardial infarction (AMI), including STEMI and NSTEMI, compared to patients without AMI.

Detailed Description

Chest pain is one of the leading reasons of hospital emergency department (ED) visits worldwide. In the US, approximately 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. Misdiagnoses may lead to discharge of patients with ACS, who should have been admitted as well as costly unnecessary hospitalizations of patients who do not have ACS.

More than 2/3 of the patients with ACS have unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI). Conventional ECG has low sensitivity of less than 50% in diagnosing these conditions. As the initial ECG in the ED is often non-diagnostic in ACS patients, the diagnosis of ST-elevation myocardial infarction (STEMI) during its early stages may also be difficult.

Analysis of high-frequency QRS components (HFQRS), which quantifies changes in the depolarization phase of the cardiac cycle, has been previously reported to be a sensitive method for detection of demand ischemia. 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 Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-06-24
• Study First Posted: 2010-06-25
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-06
• Last Update Posted: 2011-02-08
• Primary Completion: 2011-06
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age > 40 years (men and women)
• Time from onset of chest pain ≤ 12h
• AMI confirmed by biomarkers
• Clinical or electrocardiographic evidence of ischemia during recording
• Signed an informed consent

Exclusion Criteria

• Prior MI
• Prior CABG
• pre-excitation syndrome (e.g. WP)
• Atrial Fibrillation or significant ventricular arrhythmia
• BBB, intraventricular conduction delay or QRS duration > 120 ms
• Implanted pacemaker or defibrillator
• Left-ventricular hypertrophy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis of Acute Myocardial Infarction	Prior to hospitalization release	The primary end-point of the study is diagnosis of acute myocardial infarction, based on cardiac biomarkers, ECG changes clinical symptoms and coronary angiography.

Secondary Outcome Measures

Name	Time	Method
HFQRS analysis for detecting NSTEMI	Post data processing	To evaluate the usefulness of HFQRS analysis in early detection of non-ST segment elevation myocardial infarction (NSTEMI).

Trial Locations

Locations (1)

Soroka University Medical Center; 🇮🇱 Beer Sheva, Israel