Clinical trial NCT01150825: Feasibility of High Frequency QRS Analysis in Patients With Acute Myocardial Infarction
Official title: Feasibility of High Frequency QRS Analysis in Patients With Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Keywords: STEMI
NSTEMI
acute ischemia
non-invasive diagnosis
elevated troponin
Lead sponsor: BSP Biological Signal Processing Ltd.
Sponsor class: INDUSTRY
First posted: 2010-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnosis of Acute Myocardial Infarction
timeFrame: Prior to hospitalization release
Secondary outcomes:
measure: HFQRS analysis for detecting NSTEMI
timeFrame: Post data processing
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
Study officials:
affiliation: Soroka University Medical Center
name: Doron Zahger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amit G, Galante O, Davrath LR, Luria O, Abboud S, Zahger D. High-frequency QRS analysis in patients with acute myocardial infarction: a preliminary study. Ann Noninvasive Electrocardiol. 2013 Mar;18(2):149-56. doi: 10.1111/anec.12023. Epub 2012 Nov 22.