- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03445884
68 Ga-NODAGA-E[c(RGDγK)]2: Positron Emission Tomography Tracer for Imaging of Myocardial Angiogenesis
68Ga-NODAGA-E[c(RGDγK)]2: a Novel Positron Emission Tomography (PET) Tracer for in Vivo Molecular Imaging of Myocardial Angiogenesis Following Myocardial Infarction
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Ischemic heart disease is worldwide the single most frequent cause of death. The number of patients surviving acute myocardial injury is increasing due to improved acute treatment. However, after the initial repair, the tissue undergoes a remodeling phase to compensate for the damaged area. This re-modeling phase can change the structure end geometry of the heart resulting in lower ejection fraction, leading to cardiac dysfunction, which eventually leads to heart failure. Understanding and ideally modifying the reparative mechanisms following myocardial infarction is increasingly important and may lead to improved outcome.
If the heart suffers from ischemia following an acute coronary event, the tissue reacts strongly to the hypoxia. The body will as a compensatory mechanism create new vessel to provide the tissue with oxygen. This is known as the biological process of angiogenesis. This complex process involves different angiogenic and pro-fibrotic transcription factors that initiate the restoration of capillaries by sprouting from the existing endothelial cells in response to hypoxia.
Time seem essential to protect and save the myocardium. An early onset of cytokines and growth factors is associated with a decline in cardiomyocytes apoptosis, smaller infarct areas, and decreased ventricular dilation. Therefore, an early induction of angiogenesis seems important for a good prognosis of the patient.
Integrin αvβ3 is a transmembrane cell surface receptor that is markedly upregulated in states of angiogenesis. It facilitates migration and proliferation and thereby allowing cells to respond to extracellular environment. Integrin αvβ3 is thus a key player in the angiogenic process. The integrin αvβ3 has a binding site for an RGD peptide (Arg-Gly-Asp motif) and this can be targeted by PET tracers.
RGD-based PET tracers have been shown to accumulate at the site of myocardial necrosis in both human and animal studies. The uptake seems to peak a few weeks after the infarction and may correlate to recovery of cardiac function and thus serve as a prognostic marker.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Region Hovedstaden
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Copenhagen, Region Hovedstaden, Dinamarca, 2100
- Department of Physiology, Nuclear Medicine and PET
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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:
- Age over 50 years
Acute myocardial infarction Group:
- Verified first-time acute myocardial infarction treated with PCI
Control Group:
- Previous healthy
- No known cardiac disease
Exclusion Criteria:
- No prior history of acute coronary infarction
- No prior history of Heart surgery
- Not treated with anti-angiogenic medicine
- Subject with pacemaker, cochlear implant or insulin pump
- Pregnancy
- Lactation
- Severe claustrophobia
- Severe obesity (weight above 140kg)
- If a subject is in the fertile age, a pregnancy test will be use prior to injection to the PET_tracer
- If a subject is having a severe allergic reaction to the PET-tracer, the person will be excluded for the rest of the trial
- If the PET-tracer is administered subcutaneous, the person will be excluded for the rest of the trial¨
- Tupe I or II diabetes
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Acute myocardial infarctions group
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV. three times.
1-3 days after intervention, 7-10 days after intervention and 30-35 days after intervention.
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200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administrados por vía intravenosa.
Otros nombres:
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Comparador activo: Control group
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV. one time.
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200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administrados por vía intravenosa.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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To evaluate myocardial angiogenesis
Periodo de tiempo: 30-35 days
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Analysing uptake of 68Ga-NODAGA-E[c(RGDyK)]2 Positron Emission Tomography in myocardial infarction after PCI
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30-35 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and myocardial perfusion
Periodo de tiempo: 30-35 days
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Quantitative uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and change in myocardial perfusion after PCI using Rubidium 82 Positron Emission Tomography after Percutaneous coronary intervention(PCI)
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30-35 days
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Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and functional recovery
Periodo de tiempo: 30-35 days
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Quantitative uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and functional recovery using Magnetic Resonance after PCI
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30-35 days
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Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and viability
Periodo de tiempo: 30-35 days
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Quantitative uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and viability using Flour-Deoxy-Glucose Positron Emission Tomography after PCI
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30-35 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Andreas Kjær, MD, Rigshospitalet, Denmark
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EUDRACR-number: 2017-002709-36
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
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. .
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