RCT of Ghrelin in Stroke Patients

Stroke, Ischemic Clinical Trial

— MR GENTLE  

Official title:

Multicentre Randomized Trial of Ghrelin in Anterior Circulation Ischemic Stroke Treated With Endovascular Thrombectomy. A Randomized Phase 2 Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05726240
• Other study ID #: MR GENTLE
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Rijnstate Hospital
• Contact: Jeannette Hofmeijer, MD, PhD
• Phone: 0880058877
• Email: jhofmeijer[@]rijnstate.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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),

• treatment with EVT, defined as groin puncture in the angio suite,

• CT or MRI ruling out intracranial hemorrhage,

• a pre-EVT score of at least 10 on the NIHSS,

• age of 18 years or older,

• written informed consent (deferred).

Exclusion Criteria:

• pre-stroke disability defined as mRS = 2,

• life expectancy shorter than one year,

• child-bearing potential.

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	University Medical Center Utrecht	Utrecht
Netherlands	Isala	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days after stroke onset
Secondary	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 .	90 days after stroke onset
Secondary	Mortality	Mortality at 90 days	90 days after stroke onset
Secondary	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.	24 hours after stroke onset
Secondary	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.	72 hours after stroke onset
Secondary	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.	90 days after stroke onset
Secondary	Infarct size	Infarct size at 72 hours (based on Magnetic resonance imaging measurements)	72 hours after stroke onset
Secondary	Blood glucose levels	Blood glucose levels at days 1-7 (or until discharge)	Days 1-7 after stroke onset
Secondary	Blood pressure	Blood pressure at days 1-7 (or until discharge)	Days 1-7 after stroke onset
Secondary	Body temperature	Body temperature at days 1-7 (or until discharge)	Days 1-7 after stroke onset