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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by BSP Biological Signal Processing Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
BSP Biological Signal Processing Ltd.
ClinicalTrials.gov Identifier:
NCT01150825
First received: June 10, 2010
Last updated: February 6, 2011
Last verified: February 2011
  Purpose

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.


Condition
Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Feasibility of High Frequency QRS Analysis in Patients With Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by BSP Biological Signal Processing Ltd.:

Primary Outcome Measures:
  • Diagnosis of Acute Myocardial Infarction [ Time Frame: Prior to hospitalization release ] [ Designated as safety issue: No ]
    The primary end-point of the study is diagnosis of acute myocardial infarction, based on cardiac biomarkers, ECG changes clinical symptoms and coronary angiography.


Secondary Outcome Measures:
  • HFQRS analysis for detecting NSTEMI [ Time Frame: Post data processing ] [ Designated as safety issue: No ]
    To evaluate the usefulness of HFQRS analysis in early detection of non-ST segment elevation myocardial infarction (NSTEMI).


Estimated Enrollment: 50
Study Start Date: June 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
STEMI
Patients with ST segment elevation myocardial infarction, verified by elevated troponin levels
NSTEMI
Patients with non-ST segment elevation myocardial infarction, verified by elevated levels of troponin

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150825

Contacts
Contact: Doron Zahger, MD +972-8-6403468 dzahger@bgu.ac.il
Contact: Aviva Grosbard +972-8-6400721 aviva@clalit.org.il

Locations
Israel
Soroka University Medical Center Recruiting
Beer Sheva, Israel, 84101
Sponsors and Collaborators
BSP Biological Signal Processing Ltd.
Investigators
Principal Investigator: Doron Zahger, MD Soroka University Medical Center
  More Information

Additional Information:
No publications provided by BSP Biological Signal Processing Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Doron Zahger, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01150825     History of Changes
Other Study ID Numbers: ER_02_5023
Study First Received: June 10, 2010
Last Updated: February 6, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by BSP Biological Signal Processing Ltd.:
STEMI
NSTEMI
acute ischemia
non-invasive diagnosis
elevated troponin

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014