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Feasibility of High Frequency QRS Analysis in Patients With Acute Myocardial Infarction

B

BSP Biological Signal Processing

Status

Unknown

Conditions

Myocardial Infarction

Study type

Observational

Funder types

Industry

Identifiers

NCT01150825
ER_02_5023

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

STEMI
Description:
Patients with ST segment elevation myocardial infarction, verified by elevated troponin levels
NSTEMI
Description:
Patients with non-ST segment elevation myocardial infarction, verified by elevated levels of troponin

Trial contacts and locations

1

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Central trial contact

Aviva Grosbard; Doron Zahger, MD

Data sourced from clinicaltrials.gov

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