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Cardiogoniometry (CGM) for Early Diagnosis of Acute Coronary Syndromes (ACS)

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EstadoTerminado
Patrocinadores
Stiftung Institut fuer Herzinfarktforschung

Palabras clave

Abstracto

Aims of the study:
Patients in a Chest Pain Unit (CPU) are examined to clarify if the cause of pain is cardiac or not. To identify patients with ST-elevation and other electrocardiogram (ECG) modifications a normal 12-lead ECG is used. The diagnosis non-st-elevation myocardial infarction is determined with the help of the ischemic marker Troponin. However, Troponin levels are elevated earliest 3 to 4 hours after the ischemic event, so that a negative Troponin result at the time of hospital admission is insufficient. Thus the guidelines of the German Society of Cardiology demand a second measurement after 6 to 12 hours. In rare cases false positive Troponin levels have been reported (e.g. in patients with renal insufficiency).
The aim of this study is to determine if in the early phase of diagnostic assessment cardiogoniometry can improve differentiation between patients with cardiac (ischemic) emergency and patients with non-cardiac (non-ischemic) cause of pain. Furthermore it will be evaluated if cardiogoniometry is capable to diagnose patients with non-ST-elevation myocardial infarction (NSTEMI) to the same extent as Troponin. This could avoid time loss until a possibly necessary catheter intervention ("fast track").
To clarify these questions the result of the cardiogoniometry will be compared with the leading diagnosis of the Chest Pain Unit, the diagnosis at hospital discharge as well as with the angiographic findings (as a gold standard). Therefore the performance of cardiac catheterization within 72 hours after start of symptoms is a mandatory inclusion criterion.

Descripción

The cardiogoniometry vectorcardiography is a procedure that allows a stress-free and non-invasive diagnosis of myocardial ischemia: five thoracic electrodes as well as the heart flow in orthogonal summation vectors are recorded by a computer-assisted method in three dimensions.

fechas

Verificado por última vez: 03/31/2011
Primero enviado: 02/10/2011
Inscripción estimada enviada: 03/31/2011
Publicado por primera vez: 04/04/2011
Última actualización enviada: 03/31/2011
Última actualización publicada: 04/04/2011
Fecha de inicio real del estudio: 05/31/2009
Fecha estimada de finalización primaria: 03/31/2010
Fecha estimada de finalización del estudio: 04/30/2010

Condición o enfermedad

Chest Pain

Intervención / tratamiento

Other: cardiogoniometry

Fase

-

Criterio de elegibilidad

Edades elegibles para estudiar 18 Years A 18 Years
Sexos elegibles para estudiarAll
Acepta voluntarios saludablessi
Criterios

Inclusion Criteria:

- Age > 18 years

- thoracic pain, or pain radiating to neck or arm, or acute dyspnoea

- coronary angiography within 72 hours after start of symptoms

Exclusion Criteria:

- ST elevation myocardial infarction

- hemodynamically unstable patients, provided that the application of CGM may lead to an unacceptable delay in diagnosis and therapy

- lack of blood samples for troponin determination at admission

- patients with cardiac pacemaker

- cardiogenic shock

- tachycardia (HR > 100)

- > 50% extra systoles

- branch block

- atrial fibrillation

- no informed consent

Salir

Medidas de resultado primarias

1. Difference between cardiogoniometry finding and leading diagnoses of chest pain unit, coronary angiography, and at discharge in assessing the origin of chest pain [72 hours]

Aim is to examine if cardiogoniometry can provide additional information for the decision to perform a diagnostic coronary angiography and if so, which additional value it has. To assess the value of cardiogoniometry its results are compared with the leading diagnosis of the Chest Pain Unit, the diagnosis at hospital discharge as well as with the angiographic findings (as a gold standard).

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