- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03538639
Protocolo de descubrimiento de enfermedades vasculares
Background:
Some genetic diseases put increase the risk of heart and blood diseases, which are the number one cause of death and disability in the U.S. Researchers want to study diseases of the heart and/or blood vessels. They want to collect data and specimens from affected people, their family members, and healthy people.
Objective:
To study diseases of the heart and/or blood vessels.
Eligibility:
People age 2 and older who may have genetic disease affecting the heart and/or blood vessels Their relatives
Healthy volunteers
Design:
Participants will be screened with a medical history, physical exams, and imaging tests. Participants may have a few visits or visits for 2 weeks or more. This will depend on their age and disease status. Visits may include:
Photographs of the face and body
Heart tests
Samples taken of blood, urine, saliva, skin, and/or tissue
Scans. For some, a dye may be injected into a vein.
A six-minute walk test
Lung tests. For some, participants will blow into a tube. For others, they will breathe in a gas from a mask, have a small injection, then have a scan.
Stress tests while walking on a treadmill or riding a stationary bike
Ultrasound of veins and arteries
Devices outside the body testing the stiffness and function of arteries
Eye exam and eye tests. For some, a dye may be injected in a vein.
Blood pressure tests
Measurements of blood flow under the skin and in the arms and fingernail blood vessels
Devices outside the body testing flexibility of the blood vessels and skin, and skin temperature
Descripción general del estudio
Estado
Descripción detallada
The NIH provides a unique opportunity for research scientists to participate in the bench-to-bedside process, which is essential for the full implementation of translational medicine programs. The study of rare monogenetic and undiagnosed diseases is a complex bedside-to-bench-to-bedside endeavor. Recent studies show that rare genetic variants are more likely than common variants to have deleterious effects on protein structure, function, and/or expression, possibly leading to clinically relevant events. Studies of large patient populations offer the opportunity to identify rare genetic variants underlying human disease and will have impactful implications for human health. We propose to characterize the etiology and natural history of rare and orphan diseases with vascular phenotypes. We will also study rare genetic modifiers and identify novel disease mechanisms contributing to common vascular diseases. Subsequent disease-related protocols may be developed based on findings from subjects enrolled in this protocol for further intensive natural history studies and potential innovative therapeutic studies. In addition to its role in investigating individuals who are of interest to the Translational Vascular Medicine Branch (TVMB) of the NHLBI, this protocol can provide a possible avenue for admitting subjects from other NIH programs, such as the NIH Undiagnosed Diseases Program, the Center for Human Immunology Trans-institute program or other NIH protocols where subjects exhibit vascular phenotypes.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Manfred Boehm, M.D.
- Número de teléfono: (301) 435-7211
- Correo electrónico: boehmm@nhlbi.nih.gov
Copia de seguridad de contactos de estudio
- Nombre: Ruth C Brower, R.N.
- Número de teléfono: (301) 443-6036
- Correo electrónico: ruth.brower@nih.gov
Ubicaciones de estudio
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-
Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- Reclutamiento
- National Institutes of Health Clinical Center
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Contacto:
- NIH Clinical Center Office of Patient Recruitment (OPR)
- Número de teléfono: TTY dial 711 800-411-1222
- Correo electrónico: ccopr@nih.gov
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
We expect to enroll an unlimited number of subjects. The study population will be divided into groups that reflect both the potential studies that may be performed in distinct groups and the risk to benefit analysis for these groups. The appendices at the end of the protocol describe possible procedures and risk profiles for all the study subjects. Vulnerable populations, including pregnant women, children and cognitively impaired persons, may participate in this study. The groups include: 1.Adult index cases (affected) and relatives (affected and unaffected) 2.Child index cases (affected) and child relatives (affected and unaffected) 3.Healthy adult volunteers
Descripción
- INCLUSION CRITERIA:
- All subjects must be between the ages of 2-100 years old.
- Affected pregnant women if they have been referred with a known or suspected pathology or if they become pregnant while on study.
- Unaffected related pregnant women (including spouses/partners) for cord blood and tissue collection (surgical waste) only at the time of delivery.
EXCLUSION CRITERIA:
- Healthy volunteers unable to give informed consent
- Healthy volunteers who decline to have blood drawn and/or tissue studies or who do not consent to have samples stored for future research.
- Cognitively impaired individuals who are not affected.
- Cognitively impaired individuals not related to affected subjects.
- Unaffected unrelated pregnant women.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: CASE_CONTROL
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
1
Adult index cases (affected) and relatives (affected and unaffected) |
|
2
Child index cases (affected) and child relatives (affected and unaffected) |
|
3
Healthy adult volunteers |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Rapid initiation of new, disease-specific investigations to enable the collection of data and biospecimens on affected subjects, their family members and healthy controls, and to assist in the generation of diagnoses and further the understandin...
Periodo de tiempo: ongoing
|
Understanding of disease pathophysiology in subjects with uncommon vascular disease presentation. |
ongoing
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
to improve diagnosis, identify biomarkers, develop outcome measures, create centers of expertise and provide the foundation for therapy development. Clinically indicated procedures may yield data that can be used to support or guide research obj...
Periodo de tiempo: ongoing
|
to improve diagnosis, identify biomarkers, develop outcome measures, create centers of expertise and provide the foundation for therapy development. Clinically indicated procedures may yield data that can be used to support or guide research objectives. |
ongoing
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Manfred Boehm, M.D., National Heart, Lung, and Blood Institute (NHLBI)
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Palabras clave
- Historia Natural
- Etiología de las Enfermedades Raras y Huérfanas con Fenotipo Vascular
- Historia natural de las enfermedades raras y huérfanas con fenotipo vascular
- Fisiopatología de las enfermedades vasculares poco frecuentes
- Enfermedades no diagnosticadas
- Enfermedades humanas raras con características vasculares
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 180108
- 18-H-0108
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
It is not yet known
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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