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

February 6, 2011 updated by: BSP Biological Signal Processing Ltd.
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Beer Sheva, Israel, 84101
        • Recruiting
        • Soroka University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting with confirmed AMI in the intensive cardiac care unit (ICCU) of Soroka Medical Center (Beer Sheva, Israel), who are expected to undergo percutaneous coronary intervention (PCI) will be asked to participate in the study. These include both ST-elevation MI (STEMI) and non ST-elevation MI (NSTEMI) patients, with positive biomarkers and clear ongoing electrocardiographic or clinical evidence of ischemia.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
STEMI
Patients with ST segment elevation myocardial infarction, verified by elevated troponin levels
NSTEMI
Patients with non-ST segment elevation myocardial infarction, verified by elevated levels of troponin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of Acute Myocardial Infarction
Time Frame: 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.
Prior to hospitalization release

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HFQRS analysis for detecting NSTEMI
Time Frame: Post data processing
To evaluate the usefulness of HFQRS analysis in early detection of non-ST segment elevation myocardial infarction (NSTEMI).
Post data processing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BSP Biological Signal Processing Ltd.

Investigators

  • Principal Investigator: Doron Zahger, MD, Soroka University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

June 10, 2010

First Submitted That Met QC Criteria

June 24, 2010

First Posted (Estimate)

June 25, 2010

Study Record Updates

Last Update Posted (Estimate)

February 8, 2011

Last Update Submitted That Met QC Criteria

February 6, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ER_02_5023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe