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- Klinische proef NCT01150825
Feasibility of High Frequency QRS Analysis in Patients With Acute Myocardial Infarction
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Beer Sheva, Israël, 84101
- Werving
- Soroka University Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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STEMI
Patients with ST segment elevation myocardial infarction, verified by elevated troponin levels
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NSTEMI
Patients with non-ST segment elevation myocardial infarction, verified by elevated levels of troponin
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Diagnosis of Acute Myocardial Infarction
Tijdsspanne: Prior to hospitalization release
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The primary end-point of the study is diagnosis of acute myocardial infarction, based on cardiac biomarkers, ECG changes clinical symptoms and coronary angiography.
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Prior to hospitalization release
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
HFQRS analysis for detecting NSTEMI
Tijdsspanne: Post data processing
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To evaluate the usefulness of HFQRS analysis in early detection of non-ST segment elevation myocardial infarction (NSTEMI).
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Post data processing
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Doron Zahger, MD, Soroka University Medical Center
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ER_02_5023
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