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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01150825

Enrollment

Registered

2010-06-25

Start date

2010-06-30

Completion date

2011-06-30

Last updated

2011-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

STEMI, NSTEMI, acute ischemia, non-invasive diagnosis, elevated troponin

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

Israel

Contacts

Primary ContactDoron Zahger, MD

dzahger@bgu.ac.il+972-8-6403468

Backup ContactAviva Grosbard

aviva@clalit.org.il+972-8-6400721

Outcome results