Magnetic Resonance Imaging (MRI) for Aortic Dissection to Visualise Inflammation
Palabras clave
Abstracto
Descripción
Aortic dissection (AD) is a condition in which a disruption of the medial layer (in most cases provoked by a tear or an ulcer in the intima) results in separation of the aortic wall layers, with concomitant 'false lumen' formation and malperfusion of end organs.
The underlying mechanism of the condition has, until recently, remained unclear. The Pi of the present sutdy has shed light on a mechanism that shows that inflammation underlies the condition. The PI of the present study has showed that inflammation in the aorta is triggered by macrophage infiltration into the aortic wall in both pre-clinical models using animal models of the condition (murine) and in patient tissue samples obtained at time of surgery.
Macrophage infiltration into the aortic wall, as a result of activation of the cytokine, granulocyte-macrophage colony stimulating factor (GM-CSF), is the trigger for an inflammatory cascade that is presently understood to underlie the pathogenic mechanism of the condition
Non-invasive assessment of macrophage infiltration would prove that this pathogenic mechanism exists (proof-of-concept). Macrophage infiltration has been shown to be feasible by contrast-enhanced Magnetic Resonance Imaging (MRI) using ultrasmall super paramagnetic iron oxides (USPIOs).
The hypothesis of the present study is that macrophage-mediated inflammation can be visualised in the aorta of patients with AD using the USPIO-enhanced MRI technique, and use the present study to confirm this (proof-of-concept).
fechas
| Verificado por última vez: | 04/30/2019 |
| Primero enviado: | 05/06/2019 |
| Inscripción estimada enviada: | 05/08/2019 |
| Publicado por primera vez: | 05/13/2019 |
| Última actualización enviada: | 01/27/2020 |
| Última actualización publicada: | 01/28/2020 |
| Fecha de inicio real del estudio: | 09/10/2019 |
| Fecha estimada de finalización primaria: | 06/30/2020 |
| Fecha estimada de finalización del estudio: | 09/30/2020 |
Condición o enfermedad
Intervención / tratamiento
Diagnostic Test: Magnetic Resonance Imaging (MRI) using ultrasmall super paramagnetic iron oxides (USPIOs)
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Acute aortic dissection stable patients with confirmed diagnosis of acute AD. | |
| Chronic aortic dissection patients with diagnosis of chronic AD, being followed up in outpatient aortic clinic. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 40 Years A 40 Years |
| Sexos elegibles para estudiar | All |
| Método de muestreo | Probability Sample |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - Confirmed diagnosis of acute or chronic aortic dissection (>2 week after initial intimal injury) - Able and willing to comply with all study requirements. - Age > 40 years (Patients under the age of 40 years will not be included as they may have a connective tissue disorder accounting for their condition) - Able and willing to give informed consent - An adequate understanding of written and verbal English Exclusion Criteria: - Past history of systemic iron overload or haemochromatosis - Renal failure (estimated glomerular filtration rate < 30ml/min) - Contraindication to MRI - Known allergy to iron-containing compounds - Participants who have participated in another research study involving an investigational product in the past 12 weeks. - Female participants who are pregnant or lactating. - Unwilling or unable to give informed consent |
Salir
Medidas de resultado primarias
1. Visualisation of inflammation [Up to 36 hours]
2. Feasibility [Up to 36 hours]
Medidas de resultado secundarias
1. Timing [Up to 36 hours]
2. Localisation [Up to 36 hours]
