Usefulness of High-frequency QRS Analysis in the Evaluation of Patients With Chest Pain

NCT01185899 | Completed

• 1 other identifier: sor505310ctil
• Study Type: observational
• Target: 324
• Locations: 1 country
• Sites: 1

Brief Summary

Accurate detection of a heart attack (an acute myocardial infarction) is one of the most pressing needs in medicine. Recordings of the electrocardiogram (ECG) (electrical activity of the heart) are one of the first tools used to diagnose a heart attack, but the ECG is not very accurate, especially at the beginning of a heart attack. A new technique for analysing a special part of the ECG may provide more accurate detection of a heart attack. The study hypothesis is that this new technique, the HFQRS analysis, will provide important additional information to that available from the regular ECG.

Conditions

Acute Coronary Syndrome; STEMI; NSTEMI; Unstable Angina; Chest Pain

Keywords

heart attack; acute myocardial infarction; STEMI; NSTEMI; Unstable Angina; suspected acute coronary syndrome; Non-ischemic chest pain

Outcome Measures

Primary Outcomes (1)

• diagnosis or rule-out of acute coronary syndrome

  The primary end-point of the study is definite discharge diagnosis or rule-out of acute coronary syndrome, based on cardiac biomarkers, ECG changes, clinical symptoms and cardiac imaging tests.

  diagnosis or rule-out of ACS will be determined at two time points: 1) upon diacharge when discharge diagnosis is determined. Follow up information will be obtained one month post discharge

Study Arms (1)

Suspected ACS patients

Patients presenting with chest pain to the Emergency Department, who are suspected of having ACS, will be asked to participate in the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients arriving to the emergency department of Soroka University Medical Center with chest pain that is suspected of being due to acute coronary syndrome

You may qualify if:

• Patients with chest pain, suspected to have ACS
• Duration of chest pain greater than 20 minutes
• Time from onset of chest pain less than 12h
• Signed an informed consent

You may not qualify if:

• History of trauma or any other evident medical cause of chest pain
• Prior coronary artery bypass graft
• Pre-excitation syndrome (example WPW)
• Atrial Fibrillation or significant ventricular arrhythmia
• Bundle branch block, intraventricular conduction delay or
• QRS duration greater than 120 ms
• Implanted pacemaker or defibrillator
• Patients who received fibrinolytic therapy, glycoprotein IIb or IIIa inhibitors before the initial ECG recording

Sponsors & Collaborators

• Ori Galante: lead
• BSP Biological Signal Processing Ltd.: collaborator

Study Sites (1)

Soroka University Medical Center

Beersheba, 84101, Israel

Location

Related Publications (1)

• Galante O, Amit G, Granot Y, Davrath LR, Abboud S, Zahger D. High-frequency QRS analysis in the evaluation of chest pain in the emergency department. J Electrocardiol. 2017 Jul-Aug;50(4):457-465. doi: 10.1016/j.jelectrocard.2017.02.009. Epub 2017 Feb 20.

  PMID: 28341306 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Angina, Unstable; Chest Pain; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Doron Zahger, MD

  Soroka University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-PI

Study Record Dates

• First Submitted: August 18, 2010
• First Posted: August 20, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

IL (1)