Differential Metabolic Signature of Stroke Patients Undergoing Thrombolysis (DETECT)
Differential Metabolic Signature of Stroke Patients Undergoing Thrombolysis Compared to Healthy Controls
Currently, there is no reliable biomarker for stroke, meaning that treatment is often delayed and patients are often left with a disability. Stroke is one of the largest causes of mortality (death) and morbidity (disease) in the UK and affects around 120 and 15 people per 100,000 population. This has huge economic implications, with around £9 billion a year being spent on stroke in the UK alone, and health and social care costs accounting for half of this amount. Productivity losses (i.e. income costs) are estimated at £1.33 billion and benefit payments total £840 million per year.
Previous studies involving heart attack patients have suggested that succinate (a biomarker) levels rise after reperfusion (reoxygenation) of the heart tissue and in the context of ischaemia (i.e. when a restriction of blood supply to the heart has caused a heart attack and the tissue has been reoxygenated to improve blood flow around the body). Malonate is a therapeutic option to block this rise in succinate and reduce any potential resulting damage. Animal studies support these findings and have further shown that malonate prevents ischaemic brain damage and reduces the succinate increase in tissue.
However, there is currently no pre-clinical data for the release of succinate into blood, nor for stroke. This study aims to explore whether elevated succinate levels are present in stroke patients having thrombolysis (brain reperfusion). If we can show that elevated succinate levels are attributed to stroke (and not a result of thrombolysis), it might be possible to identify a therapeutic intervention at baseline for these patients and this reduce disability in all stroke patients, and healthcare costs in turn.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Descripción detallada
There are around 150,000 incidents of stroke every year in the UK alone. By the age of 75, 1 in 5 women and 1 in 6 men will have had a stroke; 26% of which will have occurred before the age of 65. Moreover, over half of all stroke survivors are left with a disability and 41% of these are discharged from hospital requiring help with daily activities. Without a reliable biomarker for stroke patients, the development of a therapeutic intervention at baseline which has the capability to reduce disability in stroke patients is not possible. There is a dire need for further research into stroke. In 2012, £56 million was spent on stroke-related care/research, compared to £544 million on cancer research and £166 million on heart disease.
Studies involving heart attack patients suggest that succinate could be used as a biomarker for stroke patients. Furthermore, the current therapeutic option used to block the rise in succinate levels, malonate, has been shown to prevent ischaemic brain damage in animal studies. No work to date has explored this phenomenon in humans with stroke and therefore this study has huge potential to bridge the gap in helping to treat stroke patients in the future and thus reduce healthcare costs.
The DETECT study is a pilot study and has been specifically designed to be as simple as possible. For stroke patients undergoing thrombolysis, they will already have a cannula inserted to aid with the procedure. We propose that research bloods could be taken from this same cannula to reduce the burden to the patient. Wherever possible we will conduct the safety follow-up with stroke patients whilst they are still an inpatient at the hospital, to again reduce the burden to the patient.
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Contactos y Ubicaciones
Ubicaciones de estudio
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Cambridge, Reino Unido
- Cambridge University Hospitals NHS Foundation Trust
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria (stroke patients):
- Be aged 18 years or over
- Present at Addenbrooke's Hospital A&E with a stroke (ischaemic stroke)
- Time of onset of confirmed stroke symptoms within 4 hours of arrival in ED
- Be eligible for thrombolysis
- Provide informed consent either prior to thrombolysis or after the initial emergency; or personal or nominated consultee declaration following the emergency
Inclusion Criteria (healthy volunteers):
- Be aged 18 years or over
- Provide informed consent
- Be healthy as determined by clinical history and examination by the investigator, a brief physical examination must be unremarkable.
Exclusion Criteria (stroke patients):
- Patients qualifying for thrombolysis but who do not give consent
- Patients under the age of 18
- Patients who are currently actively involved with another clinical trial (including observational studies)
Exclusion Criteria (healthy volunteers):
- Unable to provide informed written consent
- Participants under the age of 18
- Participants who are currently actively involved with another clinical trial (including observational studies)
- Any medical history or clinically relevant abnormality (from medical notes) that is deemed by the principal investigator and/or suitably qualified delegate to make the subject ineligible for inclusion
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
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Stroke patients
El paciente recibirá tratamiento de trombólisis como parte de su atención estándar.
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Healthy Volunteers
Healthy volunteers to act as control group for stroke patients.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Measurement of succinate in the same patients before and immediately after thrombolysis
Periodo de tiempo: Up to 12 months
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Up to 12 months
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Baseline succinate measurement from age-matched healthy volunteers
Periodo de tiempo: Up to 12 months
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Up to 12 months
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Assessment of pre and post-thrombolysis blood from stroke patients vs healthy controls
Periodo de tiempo: Up to 12 months
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Bloods will be screened using a metabolomics scanner to identify if there are any significant changes in the data
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Up to 12 months
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Thomas Krieg, MD, Cambridge University Hospital NHS Foundation Trust
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (ACTUAL)
Inicio del estudio
Finalización primaria (ACTUAL)
Finalización primaria
Finalización del estudio (ACTUAL)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (ACTUAL)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (ACTUAL)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- A094594
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
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