Intermountain INSPIRE Registry
INtermountain Healthcare Biological Samples Collection Project and Investigational REgistry for the On-going Study of Disease Origin, Progression and Treatment (Intermountain INSPIRE Registry)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This is an observational, non-randomized, open, long-term project to collect a variety of biological samples, in addition to usual or specialized care clinical information and laboratory test results, from patients who present to Intermountain Healthcare-affiliated facilities, with symptoms of any healthcare-related conditions, as well as from a general population including disease-free subjects. The INSPIRE Registry will include all subjects enrolled in the HHD registry (IRB # 1007406, approval date 01- 16-2009) and the cathlab database registry (IRB # 1008366, approval date 10/04/2000), as of IRB approval date of this INSPIRE amended protocol.
Since this is a registry database project, there are no investigational treatments, drugs or procedures associated with participation. Information obtained from this registry project will not have direct or immediate benefit for any of the participants.
Biological samples and subject information will be obtained during diagnostic procedures and/or treatment that are generally part of usual or specialized care for the underlying healthcare-related condition. Sample testing and registry data utilization for various research projects can be initiated only after the appropriate approval is obtained from a registry oversight/management committee, and when appropriate, the Institutional Review Board.
After informed consent is obtained from the patient, the biological samples will be obtained in one of the following ways:
- During a procedure from access lines inserted for the procedure, or
- When other ordered lab work is done, or
- As a separate sample collection if no other lab work is planned. Biological sample collection from the general population may be a separate blood draw and/or sample collection. Participating patients may be asked to provide one or more collections of biological samples. Biological samples may be used in current and future research tests multiple times, or until the sample is consumed. In addition, participating subjects may be asked to complete the IRBreviewed questionnaires.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Joseph B Muhlestein, MD
- Número de teléfono: 801-507-4701
- Correo electrónico: brent.muhlestein@imail.org
Copia de seguridad de contactos de estudio
- Nombre: Patti Spencer
- Número de teléfono: 801-507-4778
- Correo electrónico: patti.spencer@imail.org
Ubicaciones de estudio
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Utah
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Murray, Utah, Estados Unidos, 84143
- Reclutamiento
- Intermountain Medical Center and Intermountain Clinics
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Contacto:
- Joseph B Muhlestein, MD
- Número de teléfono: 801-507-4701
- Correo electrónico: brent.muhlestein@imail.org
-
Contacto:
- Patti Spencer
- Número de teléfono: 801-507-4778
- Correo electrónico: patti.spencer@imail.org
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Males or females of any age, any ethnicity, diagnosed with any healthcare-related conditions, presenting to an Intermountain Healthcare-affiliated facility or males or females of any age, any ethnicity, with or without any healthcare-related conditions, including disease-free subjects, from a general population that may include unaffected family members
- Patient or patient's representative has the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures, using a form that is approved by the applicable IRB.
Exclusion Criteria:
- Inability or refusal of the patient and/or the patient's legally-acceptable representative to provide informed consent for any reason.
- Other conditions that in the opinion of the Principal Investigator or Co-Investigator(s) may increase risk to the subject and/or compromise the quality of the registry project.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Ecológico o Comunitario
- Perspectivas temporales: Futuro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Mortalidad por cualquier causa
Periodo de tiempo: 10 años
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10 años
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 1024811
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