- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00285922
Novel Method to Diagnose Acute Myocardial Ischemia
Comparison of Estimated Body Surface Potential Mapping With Standard Electrocardiography in Patients Presenting to the Emergency Department With Chest Pain
Descripción general del estudio
Estado
Descripción detallada
The overall aims of the proposed research are (1) to improve the ECG diagnosis of patients who present to the ER with heart attack and (2) to improve the monitoring of recurrent heart attack in these patients while they are being treated in the hospital. The proposed research will test a promising new technique, termed estimated body surface potential mapping. This novel method involves estimating ECG information across the entire upper body from 10 electrodes placed in strategic positions.
In patients who come to the ER complaining of chest pain, shortness of breath or some other symptom of a heart attack, we will: (1) record continuous, 24 hour, standard ECGs (usual, current method used) and at the same time (2)record continuous 24 hour experimental recordings from which a body surface map will be calculated. Two experts who do not know whether the patient actually had a heart attack or not will analyze these 2 methods for signs of heart attack. We expect that more correct diagnoses will happen with the new experimental body mapping technique. The correct diagnosis will be based upon a blood test which is considered the best test to prove there is heart damage. The blood test does not become abnormal until hours after the attack, however, so the ECG diagnosis must be made and treatment initiated before results of the blood test are available.
If the expected diagnostic improvements are confirmed in this study, the long term benefit would be more accurate ER decision-making of patients with heart attack and more timely treatment. The benefits of more timely and definitive treatment would be an improvement in long-term survival, functional status, and quality of life in patients treated for heart attack.
We plan to enroll 1,320 patients who present to the ER at the University of California, San Franicsco to participate in the study. We will follow these patients for a year following their ER visit to determine whether they survived and which ECG method predicted death more accurately.
Tipo de estudio
Inscripción
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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San Francisco, California, Estados Unidos, 94143
- University of California San Francisco
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- All individuals who present to the UCSF emergency room between 7 am and 7 pm, Monday through Friday, who have symptoms of myocardial infarction.
Exclusion Criteria:
- Patients with left bundle branch block or ventricular pacemaker rhythm
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Barbara J Drew, PhD, University of California, San Francisco
- Director de estudio: Robert M Lux, PhD, University of Utah, Salt Lake
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Necrosis
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Dolor
- Manifestaciones neurológicas
- Dolor de pecho
- Angina de pecho
- Infarto de miocardio
- Infarto
- Enfermedad de la arteria coronaria
- Isquemia miocardica
- Enfermedad coronaria
- Isquemia
- Angina Inestable
Otros números de identificación del estudio
- RO1 HL69758-10
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