- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00001622
Study of the Response of Human Small Blood Vessels
Study of the Relation Between In Vivo and In Vitro Response of Human Small Vessels
A layer of cells called the endothelium line the walls of blood vessels. These cells produce substances that control the tone of blood vessels and thus control blood flow through the vessel. One of the substances produced involved in the control of blood vessel function is nitric oxide. Nitric oxide (NO) plays a role in the relaxation of blood vessels.
Researchers have been interested in the function of the endothelium in patients with high blood pressure (essential hypertension) and patients with high cholesterol (hypercholesterolemia).
After conducting studies on the endothelium and nitric oxide, researchers have found that the endothelium is indeed functioning abnormally in patients with high blood pressure and high cholesterol. In addition, researchers have determined that the dysfunction is a result of abnormalities in the nitric oxide (NO) system.
In this study researchers plan to investigate the relationship between blood vessel responses in real-life settings versus laboratory settings in normal volunteers, patients with high blood pressure, and patients with high cholesterol.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- National Heart, Lung and Blood Institute (NHLBI)
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Patients (men and nonpregnant women) with systemic hypertension, patients with hypercholesterolemia, and normal volunteers.
All blood pressure recordings must be consistently elevated.
No renovascular hypertension or other etiologies for elevated blood pressure.
No definite evidence of accelerated or malignant hypertension (diastolic pressures above 115 mmHg, with associated encephalopathic changes, papilledema, progressive renal failure, or congestive heart failure), or serious intercurrent illness.
Patients in whom withdrawal of antihypertensive medications is considered hazardous are ineligible.
Patients in whom the blood pressure remains at normal levels 2 weeks after withdrawal of antihypertensive treatment will be closely monitored until they become hypertensive, at which time they will undergo the study. Patients in whom blood pressure does not increase after 2 months of discontinuation of therapy will be excluded from the study.
Patients with coexistent hypertension and hypercholesterolemia are ineligible.
Normal volunteers who are not taking any kind of medication are eligible.
No history of diabetes, peripheral vascular disease, coagulopathy, or any other disease predisposing to vasculitis or Raynaud's phenomenon.
No history of keloid formation.
All patients must be capable of giving informed consent for all procedures.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Furchgott RF. Role of endothelium in responses of vascular smooth muscle. Circ Res. 1983 Nov;53(5):557-73. doi: 10.1161/01.res.53.5.557. No abstract available.
- Falloon BJ, Heagerty AM. In vitro perfusion studies of human resistance artery function in essential hypertension. Hypertension. 1994 Jul;24(1):16-23. doi: 10.1161/01.hyp.24.1.16.
- Goode GK, Heagerty AM. In vitro responses of human peripheral small arteries in hypercholesterolemia and effects of therapy. Circulation. 1995 Jun 15;91(12):2898-903. doi: 10.1161/01.cir.91.12.2898.
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
- 970098
- 97-H-0098
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