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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00339105
• Other study ID #: SHEBA-06-4114-SM-CTIL
• Status: Recruiting
• Phase: Phase 3
• First received: June 19, 2006
• Last updated: January 14, 2007
• Start date: June 2006
• Est. completion date: January 2007

Study information

• Verified date: January 2007
• Source: Sheba Medical Center
• Contact: Shlomi Matetzky, MD
• Phone: +972-52-6667122
• Email: shlomi.matetzky[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain
• Syndrome

Locations

Country	Name	City	State
Israel	The Chest Pain Unit, ER, Sheba Medical Center, Tel-Hashomer	Ramat-Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Abboud S, Zlochiver S. High-frequency QRS electrocardiogram for diagnosing and monitoring ischemic heart disease. J Electrocardiol. 2006 Jan;39(1):82-6. — View Citation

External Links

•   BSP Ltd. is the company that developed the HyperQ system