- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Leicester, Storbritannien, LE1 5WW
- University Hosptial of Leicester NHS Trust
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
cerebral blood flow velocity
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
dynamic cerebral autoregulation
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Thompson G Robinson, MD, FRCP, University of Leicester
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 0538
Plan för individuella deltagardata (IPD)
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Kliniska prövningar på Ischemisk stroke
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Lawson Health Research InstituteHeart and Stroke Foundation of OntarioAvslutad
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Uppsala County Council, SwedenOkändAkut stroke | TIA (Transient Ischemic Attack)Sverige
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University of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São PauloAvslutadKranskärlssjukdom | Cerebral stroke | TIA (Transient Ischemic Attack)Brasilien
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Merck Sharp & Dohme LLCAvslutadKärlsjukdomar | Perifera vaskulära sjukdomar | Migränstörningar | Hjärtsjukdom | Cerebrovaskulär olycka | TIA (Transient Ischemic Attack)
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B.P. Koirala Institute of Health SciencesAvslutad
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University of Kansas Medical CenterAvslutadAllmän kirurgiFörenta staterna
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University Hospital, LilleAvslutadHypovolemi | Somatisk smärtaFrankrike
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Ain Shams UniversityAvslutad
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RekryteringOrofaryngeal cancer | Maligna neoplasmer i munhålan och svalget i läpparnaFörenta staterna