Feasibility of High Frequency QRS Analysis in Patients With Acute Myocardial Infarction
Recruitment status was Recruiting
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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 |
- 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.
- 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 |
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.
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| Contact: Doron Zahger, MD | +972-8-6403468 | dzahger@bgu.ac.il |
| Contact: Aviva Grosbard | +972-8-6400721 | aviva@clalit.org.il |
| Israel | |
| Soroka University Medical Center | Recruiting |
| Beer Sheva, Israel, 84101 | |
| 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 June 13, 2013