A Phase 2 interventional study of Ghrelin in Stroke, Ischemic, sponsored by Rijnstate Hospital. Not yet recruiting at 3 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-25.
Sponsored by Rijnstate Hospital · Phase 2, Interventional, and Treatment
About half of the patients with acute ischemic stroke treated with endovascular thrombectomy (EVT) remain dependent on the help of others or die in the first 90 days. We hypothesize that treatment with ghrelin, started in the first six hours after stroke onset, improves early recovery and long-term functional outcome in these patients. Ghrelin is a naturally occurring hormone and mildly excitatory neurotransmitter also known as the 'hunger hormone.' Treatment with acylated ghrelin consistently improved functional and histological recovery in in vitro and in vivo models of ischemic stroke.
We will include 80 patients with acute ischemic stroke caused by large vessel occlusion of the anterior circulation, eligible for EVT. The study population will be drawn from adult patients with acute ischemic stroke treated with EVT at UMC Utrecht, Rijnstate, MST or Isala.
Treatment in the intervention group will consist of intravenous acylated ghrelin, 600micrg dissolved in 50cc normal saline, by bolus (short term) infusion in 30 minutes, twice daily, for five days. This treatment will be additional to standard treatment, including intravenous thrombolysis, if indicated.
7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 80 is above the median of 50 across 5,366 interventional studies indexed under Stroke.
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Exclusion Criteria:
Treatment in the intervention group will consist of intravenous acylated ghrelin, 600micrg dissolved in 50cc normal saline, by bolus (short term) infusion in 30 minutes, twice daily, for five days. This treatment will be additional to standard treatment, including intravenous thrombolysis, if indicated.
Drug: Ghrelin
Treatment in the standard group consists of local practices for the treatment of stroke, including intravenous thrombolysis, if indicated.
Treatment in the intervention group will consist of intravenous acylated ghrelin, 600micrg dissolved in 50cc normal saline, by bolus (short term) infusion in 30 minutes, twice daily, for five days. This treatment will be additional to standard treatment, including intravenous thrombolysis, if indicated.
National Institutes of Health Stroke Scale score
The primary outcome measure is the score on the National Institutes of Health Stroke Scale at seven days (±1) after stroke onset or at discharge, if earlier. The NIHSS is a continuous scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.
Time frame: 7 days after stroke onset
Modified Rankin Scale score
The score on the Modified Rankin Scale at 90 days after stroke onset. The mRS is an ordinal hierarchical scale that describes disabilities encountered post stroke, incorporating six categories from 0 (complete recovery) up to and including 5 (severe disability). 'Death' is assigned a score of 6 .
Time frame: 90 days after stroke onset
Mortality
Mortality at 90 days
Time frame: 90 days after stroke onset
National Institutes of Health Stroke Scale score
Scores on National Institutes of Health Stroke Scale at 24 hours after stroke onset. The NIHSS is a continuous scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit. The NIHSS is a continuous scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.
Time frame: 24 hours after stroke onset
National Institutes of Health Stroke Scale score
Scores on National Institutes of Health Stroke Scale at 72 hours after stroke onset. The NIHSS is a continuous scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit. The NIHSS is a continuous scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.
Time frame: 72 hours after stroke onset
Telephonic Montreal Cognitive Assessment
Score on the telephone version of the Montreal Cognitive Assessment at 90 days. The MoCA 5-minute protocol consists of 4 subtests examining 5 cognitive domains, including attention, verbal learning and memory, executive functions/language, and orientation. Total scores of the MoCA 5-minute protocol range between 0 and 30 with lower scores indicating a better cognition.
Time frame: 90 days after stroke onset
Infarct size
Infarct size at 72 hours (based on Magnetic resonance imaging measurements)
Time frame: 72 hours after stroke onset
Blood glucose levels
Blood glucose levels at days 1-7 (or until discharge)
Time frame: Days 1-7 after stroke onset
Blood pressure
Blood pressure at days 1-7 (or until discharge)
Time frame: Days 1-7 after stroke onset
Body temperature
Body temperature at days 1-7 (or until discharge)
Time frame: Days 1-7 after stroke onset
Plan to share: Undecided
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This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Rijnstate Hospital