MR GENTLE: Multicentre Randomized Trial of Ghrelin in Anterior Circulation Ischemic Stroke Treated With Endovascular Thrombectomy. A Randomized Phase 2 Trial
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ghrelin treatment 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 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.
|
| No Intervention: Standard care
|
Outcome Measures
Primary Outcome Measures
- ational Institutes of Health Stroke Scale (NIHSS) score [7 days after stroke onset]
The primary outcome measure is the score on the NIHSS at seven days (±1) after stroke onset or at discharge, if earlier.
Secondary Outcome Measures
- Modified Rankin Scale (mRS) score [90 days after stroke onset]
The score on the mRS at 90 days after stroke onset
- Mortality [90 days after stroke onset]
Mortality at 90 days
- NIHSS score [24 hours after stroke onset]
Scores on NIHSS at 24 hours after stroke onset
- NIHSS score [72 hours after stroke onset]
Scores on NIHSS at 72 hours after stroke onset
- t-MoCA [90 days after stroke onset]
Score on the telephone version of the Montreal Cognitive Assessment (t-MoCA) at 90 days
- Infarct size [72 hours after stroke onset]
Infarct size at 72 hours (based on MRI measurements)
- Blood glucose levels [Days 1-7 after stroke onset]
Blood glucose levels at days 1-7 (or until discharge)
- Blood pressure [Days 1-7 after stroke onset]
Blood pressure at days 1-7 (or until discharge)
- Body temperature [Days 1-7 after stroke onset]
Body temperature at days 1-7 (or until discharge)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
a clinical diagnosis of acute ischemic stroke, caused by intracranial large vessel occlusion of the anterior circulation (distal intracranial carotid artery or middle (M1/proximal M2) cerebral artery) confirmed by neuro-imaging (CTA or MRA),
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treatment with EVT, defined as groin puncture in the angio suite,
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CT or MRI ruling out intracranial hemorrhage,
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a pre-EVT score of at least 10 on the NIHSS,
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age of 18 years or older,
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written informed consent (deferred).
Exclusion Criteria:
-
pre-stroke disability defined as mRS ≥ 2,
-
life expectancy shorter than one year,
-
child-bearing potential.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medisch Spectrum Twente | Enschede | Netherlands | ||
| 2 | University Medical Center Utrecht | Utrecht | Netherlands | ||
| 3 | Isala | Zwolle | Netherlands |
Sponsors and Collaborators
- Rijnstate Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MR GENTLE