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

NCT ID: NCT01150825

Last Updated: 2011-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Myocardial Infarction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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STEMI

Patients with ST segment elevation myocardial infarction, verified by elevated troponin levels

No interventions assigned to this group

NSTEMI

Patients with non-ST segment elevation myocardial infarction, verified by elevated levels of troponin

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BSP Biological Signal Processing Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Soroka University Medical Center

Principal Investigators

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Doron Zahger, MD

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Locations

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Soroka University Medical Center

Beersheba, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Doron Zahger, MD

Role: CONTACT

+972-8-6403468

Aviva Grosbard

Role: CONTACT

+972-8-6400721

References

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Amit G, Galante O, Davrath LR, Luria O, Abboud S, Zahger D. High-frequency QRS analysis in patients with acute myocardial infarction: a preliminary study. Ann Noninvasive Electrocardiol. 2013 Mar;18(2):149-56. doi: 10.1111/anec.12023. Epub 2012 Nov 22.

Reference Type DERIVED
PMID: 23530485 (View on PubMed)

Related Links

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Other Identifiers

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ER_02_5023

Identifier Type: -

Identifier Source: org_study_id

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