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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01150825
• Other study ID #: ER_02_5023
• Status: Recruiting
• Phase: N/A
• First received: June 10, 2010
• Last updated: February 6, 2011
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: February 2011
• Source: BSP Biological Signal Processing Ltd.
• Contact: Doron Zahger, MD
• Phone: +972-8-6403468
• Email: dzahger[@]bgu.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Beer Sheva

Sponsors (1)

Lead Sponsor	Collaborator
BSP Biological Signal Processing Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of Acute Myocardial Infarction	The primary end-point of the study is diagnosis of acute myocardial infarction, based on cardiac biomarkers, ECG changes clinical symptoms and coronary angiography.	Prior to hospitalization release	No
Secondary	HFQRS analysis for detecting NSTEMI	To evaluate the usefulness of HFQRS analysis in early detection of non-ST segment elevation myocardial infarction (NSTEMI).	Post data processing	No

External Links

•   Sponsor Website