Usefulness of High-frequency QRS Analysis in the Evaluation of Patients With Chest Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01185899|
Recruitment Status : Completed
First Posted : August 20, 2010
Last Update Posted : November 20, 2015
|Condition or disease|
|Acute Coronary Syndrome STEMI NSTEMI Unstable Angina Chest Pain|
Chest pain is one of the leading reasons for hospital emergency department (ED) visits worldwide. In the United States (US), over 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. Nearly half of patients hospitalized for unstable angina eventually receive a non-cardiac-related diagnosis. Nonetheless, 2-8% of patients with myocardial infarction (MI) are inappropriately discharged from the ED and mortality rates among patients with an MI who were mistakenly sent home are disproportionately higher (25-33%) than those among patients who were admitted.
Although the ECG is a mainstay in the management of suspected ACS, it has major limitations in both sensitivity and specificity for diagnosis of ACS. The initial 12-lead ECG in the ED is often non-diagnostic in ACS patients, especially in non-ST elevation MI (NSTEMI) and unstable angina (UA), and therefore cannot rule-out ischemia or infarction. Elevation in serum biomarkers is usually not detectable for 4-6 hours after an MI, and some patients do not show a biomarker elevation for as long as 12 hours. Consequently, new clinical tools for early risk stratification of patients with acute chest pain are being sought.
Conventional analysis of ST segment deviations aims to detect repolarization abnormalities. However, ischemia may also bring about changes in the depolarization phase of the electrical cardiac cycle. These depolarization changes can be detected and quantified using analysis of the high-frequency components of the QRS complex (HFQRS). HFQRS analysis has been previously reported to be a sensitive method for detection of demand ischemia during exercise testing. 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|
|Actual Enrollment :||324 participants|
|Official Title:||The Usefulness of High-frequency QRS Analysis in the Evaluation of Patients Presenting to the Emergency Department With Chest Pain|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
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.
- diagnosis or rule-out of acute coronary syndrome [ Time Frame: 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01185899
|Soroka University Medical Center|
|Beer Sheva, Israel, 84101|
|Principal Investigator:||Doron Zahger, MD||Soroka University Medical Center|