The Usefulness of HyperQ Recordings for the Early Diagnosis of Acute Coronary Syndrome in Patients Presenting With Chest Pain - Full Text View

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00339105

Purpose

The purpose of the study is to assess the usefulness of high Frequency mid-QRS analysis in identifying the ischemic origin of patients presenting to the Emergency Room (ER)with Chest pain.

Condition	Phase
Acute Coronary Syndrome	Phase III

MedlinePlus related topics: Chest Pain

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Longitudinal, Defined Population, Prospective Study
Official Title:	The Usefulness of HyperQ Recordings for the Early Diagnosis of Acute Coronary Syndrome in Patients Presenting With Chest Pain

Further study details as provided by Sheba Medical Center:

Estimated Enrollment:	50
Study Start Date:	June 2006
Estimated Study Completion Date:	January 2007

Detailed Description:

Introduction:

Chest pain is the leading cause of urgent admission to the Emergency Department (ED) in western countries.Acute Coronary Syndrome(ACS) 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.

Objectives:

To evaluate the usefulness of High Frequency mid-QRS analysis in identifying the ischemic patients out of all patients presenting to the Emergency Room (ER) with chest pain.

Comparisons:

A continuous High Frequency Mid-QRS recording will be performed using the HyperQ System (BSP Ltd.) and compared to clinical, electrophysiologic and laboratory results. The golden standards used to compare the methods will be either CT-Angio, Echocardiography or Cardiac SPECT. A follow-up inquiry will be performed after 3 months and Coronary Angiography results will be sought and compared as well.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age ≥18 years
Patients with chest pain, with possible ACS.
Patients admitted to the ‘chest pain unit’
Chest pain appeared within 24 hours prior to admission to the ‘chest pain unit’
No history of trauma or any other evident medical cause of chest pain
Signed an Informed Consent

Exclusion Criteria:

Implanted pacemaker or defibrillator
History of trauma or other evident medical cause of chest pain
Patients admitted to Intensive Cardiac Care Unit or intermediate Cardiac Care Unit
Patients discharged from the ER
Patients with Bundle-Branch-Block or other intra-ventricular delay of more than 120 mSec

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00339105

Contacts

Contact: Shlomi Matetzky, MD

+972-52-6667122

shlomi.matetzky@sheba.health.gov.il

Locations

Israel
The Chest Pain Unit, ER, Sheba Medical Center, Tel-Hashomer	Recruiting
Ramat-Gan, Israel
Principal Investigator: Shlomi Matetzky, MD

Sponsors and Collaborators

Sheba Medical Center

Investigators

Principal Investigator:

Shlomi Matetzky, MD

Head of Chest Pain Unit, ER, Sheba Medical Center

More Information

BSP Ltd. is the company that developed the HyperQ system This link exits the ClinicalTrials.gov site

Publications:

Abboud S, Zlochiver S. High-frequency QRS electrocardiogram for diagnosing and monitoring ischemic heart disease. J Electrocardiol. 2006 Jan;39(1):82-6. No abstract available.

Study ID Numbers:	SHEBA-06-4114-SM-CTIL
Study First Received:	June 19, 2006
Last Updated:	January 14, 2007
ClinicalTrials.gov Identifier:	NCT00339105
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

Acute
Coronary
Syndrome
HyperQ
High

Frequency
ECG
chest
pain

Study placed in the following topic categories:

Heart Diseases
Myocardial Ischemia
Acute Coronary Syndrome
Vascular Diseases

Pain
Ischemia
Chest Pain

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009