- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02932540
Head Position on Cerebral Haemodynamics in Acute Ischemic Stroke and Controls
The Effects of Head Positioning on Beat to Beat Cerebral Haemodynamics: a Comparison Between Acute Stroke Patients and Healthy Control Subjects
Přehled studie
Detailní popis
In the United Kingdom (UK) alone, approximate 100,000 people suffer a stroke each year. Improved management of stroke patients not only reduces morbidity and mortality, but also reduces the cost of long term social care.
The brain has control systems (i.e.cerebral autoregulation) to maintain blood flow to the brain, over a relatively wide blood pressure range. Cerebral Autoregulation can be described as static, reflecting the integrity of such mechanisms over time, or dynamic, occurring in response to sudden fluctuations in perfusion pressure. When blood pressure drops, small arteries increase in size to restore flow levels, and when blood pressure rises, they narrow to protect the most delicate blood vessels. It is known that sudden decompensated blood pressure (BP) changes can occur after stroke, this could result in brain bleeding and swelling when there is uncontrolled increased blood flow, or reduce the viability of tissue surrounding the stroke area when there is reduced blood flow to the brain.
It is known that the clot busting agent (Alteplase), the main effective treatment used in the acute stroke can only improve blood flow in already blocked arteries in 50% of patients. Therefore, as well as attempts to treat blockage of major vessel, improving the blood flow through vessel that bypass the blocked vessel around the stroke area (penumbra) could be another potential therapeutic approach in acute ischaemic stroke patients. A simple way of increase blood flow to these penumbral area might be just lower the head of acute stroke patients into a lying flat position. Several observational studies have investigated the effects of head positioning on blood flow to the brain in a healthy population, however few studies carried out on acute ischaemic stroke patients so far.
Cerebral autoregulation can be assessed non-invasively by the use of Trans Cranial Doppler (TCD). This means using ultrasound probes over both sides of the head to measure changes in blood flow in one of the main brain arteries (the middle cerebral artery) in response to beat to beat changes in blood pressure dynamic cerebral autoregulation. This research will use the noninvasive technique of Trans Cranial Doppler to see how blood flow changes during different head position between acute ischaemic stroke patients and healthy controls, as well as over time during recovery after a stroke. This knowledge will help us to understand the changes in brain blood flow control and blood pressure in stroke patients, with implications of diagnosis, prognosis, and treatment of the disease.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Leicester, Spojené království, LE1 5WW
- University Hosptial of Leicester NHS Trust
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Informed volunteer consent, patient consent or personal consultee declaration form
- Male or female, aged 18 years or above
- Able (in the Investigator's opinion) and willing to comply with all study requirements
- Willing to allow his or her General Practitioner (GP) to be notified of participation in the study Stroke Patient-specific Inclusion Criteria
- Clinical diagnosis of ischaemic stroke within 24 hours of onset (for patients waking with a stroke, time of onset will be taken to be the time when the patient was last asymptomatic)
Exclusion Criteria:
Male or Female, aged under 18 years
- Unable (in the Investigator's opinion) or unwilling to comply with any study requirements
- Participants who practice yoga regularly
- Female participants who are pregnant, lactating or planning pregnancy during the course of the study Stroke Patient-specific Exclusion Criteria
- Clinical diagnosis of stroke greater than 24 hours from onset
- Having had a resolved transient ischaemic attack (TIA) (i.e. neurological symptoms completely resolved upon hospital presentation)
- Definite clinical indication to 'sitting up' (≥30⁰) head position (i.e. pneumonia, decompensated heart failure)
- Definite clinical indication to lying flat (0⁰) head position (i.e. shock, airways obstruction)
- Co-morbidity with anticipated life expectancy less than 3 months
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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Healthy controls
healthy controls subjects who have age, sex and Blood pressure matched with the acute ischaemic stroke patient
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patient can be allocated to the transient change of the head position, persistent lying flat position in the first 24 hours of the hospital admission and persistent sitting up in the first 24 hours of the hospital admission
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AIS patient-transient arm
transient change of head position from lying flat (0 degree) to sitting up (30 degree)
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patient can be allocated to the transient change of the head position, persistent lying flat position in the first 24 hours of the hospital admission and persistent sitting up in the first 24 hours of the hospital admission
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AIS patient - persistent lying flat
lying flat (0 degree) head position for the first 24 hours in the hospital admission
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patient can be allocated to the transient change of the head position, persistent lying flat position in the first 24 hours of the hospital admission and persistent sitting up in the first 24 hours of the hospital admission
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AIS patient - persistent sitting up
sitting up ( 30 degree) head position for the first 24 hours in the hospital admission
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patient can be allocated to the transient change of the head position, persistent lying flat position in the first 24 hours of the hospital admission and persistent sitting up in the first 24 hours of the hospital admission
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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cerebral blood flow velocity
Časové okno: within 24 hours, 72 hours and 3 months of the stroke symptom onset
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percentage change of the cerebral blood flow velocity in response to change of the head position within 24 hours, 72 hours and 3 months of the stroke symptom onset
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within 24 hours, 72 hours and 3 months of the stroke symptom onset
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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dynamic cerebral autoregulation
Časové okno: within 24 hours, 72 hours and 3 months of stroke symptom onset
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change of dynamic cerebral autoregulation within 24 hours, 72 hours and 3 months of the stroke symptom onset.
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within 24 hours, 72 hours and 3 months of stroke symptom onset
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Neurovascular coupling
Časové okno: within 24 hours, 72 hours and 3 months of stroke symptom onset
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change of neurovascular coupling within 24 hours, 72 hours and 3 months of stroke symptom onset
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within 24 hours, 72 hours and 3 months of stroke symptom onset
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Carbon dioxide reactivity
Časové okno: within 24 hours, 72 hours and 3 months of stroke symptom onset
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change of carbon dioxide reactivity within 24 hours, 72 hours and 3 month of stroke symptom onset.
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within 24 hours, 72 hours and 3 months of stroke symptom onset
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Thompson G Robinson, MD, FRCP, University of Leicester
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 0538
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