- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00001961
MRI Evaluation of Chest Pain
MRI Evaluation of Chest Pain Compatible With Myocardial Ischemia
This study will assess the value of magnetic resonance imaging (MRI) in detecting heart attack and heart attack risk in patients who come to the hospital emergency room because of chest pain. It will also investigate whether MRI can help predict the coronary status of patients 4 to 6 weeks and 1 year after emergency room admission.
Patients who come to the emergency room of Suburban Hospital in Bethesda, MD, because of chest pain may be asked to enroll in this study if they have not been diagnosed as having a heart attack. Participating patients will undergo a MRI scan as soon as emergency room doctors determine they are in stable condition. For this procedure, the patient lies on a table that slides into the MRI scanner-a large tubular machine with a magnetic field. During the scan, a contrast material is injected into the vein. This material brightens the image of the heart so that the blood flow can be seen. The scan will show if there are areas of heart muscle that received insufficient blood flow. A second scan will be done within 72 hours to look for coronary artery blockage that may require treatment. Patients will be followed by telephone 4 to 8 weeks after the scans and again 1 year after the scans to ask about any significant medical problems that may have occurred during those time periods.
This study will provide information that may improve emergency treatment of patients with acute chest pain by clarifying which patients require immediate medical treatment, which should be admitted to the hospital for further evaluation, and which may safely be discharged from the hospital.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Maryland
-
Bethesda, Maryland, Estados Unidos, 20892
- National Heart, Lung and Blood Institute (NHLBI)
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
INCLUSION CRITERIA:
Ages above age 21 (children are excluded because myocardial infarction is so rare in this population that the pre-test probability is comparable to the patients with less than 30 minutes of symptoms. Both of these groups have too small a fraction of true positive events to benefit from testing with a sensitivity and specificity of approximately 0.85. If initial results are better, we will reexamine the suitability of these tests for low risk populations).
Capable of giving informed consent.
30 minutes of chest pain compatible with myocardial ischemia (chest pain score greater than 4).
Less than 270 pounds.
EXCLUSION CRITERIA:
Medical exclusions:
Patient states she may be pregnant (confirmed by urine or blood testing).
Severe congestive heart failure (unable to lie flat in bed).
Subjects on a mechanical ventilator.
MRI exclusions:
Subjects with a cardiac pacemaker or implantable defibrillator.
Subjects with a cerebral aneurysm clip.
Subjects with a neural stimulator (e.g. TENS-Unit).
Subjects with any type of ear implant.
Subjects with metal in eye (e.g. from machining).
Subjects with implanted devices (e.g. insulin pump, drug infusion device).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Tatum JL, Jesse RL, Kontos MC, Nicholson CS, Schmidt KL, Roberts CS, Ornato JP. Comprehensive strategy for the evaluation and triage of the chest pain patient. Ann Emerg Med. 1997 Jan;29(1):116-25. doi: 10.1016/s0196-0644(97)70317-2.
- Selker HP. Coronary care unit triage decision aids: how do we know when they work? Am J Med. 1989 Nov;87(5):491-3. doi: 10.1016/s0002-9343(89)80602-3. No abstract available.
- Weingarten SR, Ermann B, Riedinger MS, Shah PK, Ellrodt AG. Selecting the best triage rule for patients hospitalized with chest pain. Am J Med. 1989 Nov;87(5):494-500. doi: 10.1016/s0002-9343(89)80603-5.
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
Otros números de identificación del estudio
- 000025
- 00-H-0025
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Resonancia magnética
-
Rennes University HospitalBayerTerminadoEsclerosis múltiple (EM) | Enfermedad inflamatoriaFrancia
-
Abbott Medical DevicesTerminado
-
Mohamed Ibrahim AbbasDesconocidoLesión Vertebral
-
Centre Hospitalier St AnneAssistance Publique - Hôpitaux de Paris; National Research Agency, France; CENIR... y otros colaboradoresDesconocidoDepresión adolescenteFrancia
-
Assistance Publique Hopitaux De MarseilleDesconocido
-
Stanford UniversityColumbia University; University of ManchesterReclutamientoCarreraEstados Unidos
-
Sheffield Teaching Hospitals NHS Foundation TrustReclutamientoCáncer de cabeza y cuelloReino Unido
-
Hospices Civils de LyonReclutamiento
-
Assistance Publique - Hôpitaux de ParisReclutamientoEsclerosis múltiple | Enfermedad inflamatoriaFrancia
-
University of UtahTerminado