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RCT of Ghrelin in Stroke Patients (MR GENTLE)

Primary Purpose

Stroke, Ischemic

Status
Not yet recruiting
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Ghrelin
Sponsored by
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring Endovascular thrombectomy, Ghrelin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medisch Spectrum Twente
  • University Medical Center Utrecht
  • Isala

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ghrelin treatment

Standard care

Arm Description

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.

Treatment in the standard group consists of local practices for the treatment of stroke, including intravenous thrombolysis, if indicated.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 .
Mortality
Mortality at 90 days
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.
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.
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.
Infarct size
Infarct size at 72 hours (based on Magnetic resonance imaging measurements)
Blood glucose levels
Blood glucose levels at days 1-7 (or until discharge)
Blood pressure
Blood pressure at days 1-7 (or until discharge)
Body temperature
Body temperature at days 1-7 (or until discharge)

Full Information

First Posted
February 1, 2023
Last Updated
July 22, 2023
Sponsor
Rijnstate Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05726240
Brief Title
RCT of Ghrelin in Stroke Patients
Acronym
MR GENTLE
Official Title
Multicentre Randomized Trial of Ghrelin in Anterior Circulation Ischemic Stroke Treated With Endovascular Thrombectomy. A Randomized Phase 2 Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
Endovascular thrombectomy, Ghrelin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This will be a phase 2 multicenter clinical trial with random treatment allocation, open label treatment and blinded endpoint assessment (PROBE design). The intervention contrast will be intravenous acylated ghrelin in addition to standard care (intervention group) vs. standard care alone (control group).
Masking
None (Open Label)
Masking Description
PROBE design
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ghrelin treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Treatment in the standard group consists of local practices for the treatment of stroke, including intravenous thrombolysis, if indicated.
Intervention Type
Drug
Intervention Name(s)
Ghrelin
Intervention Description
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.
Primary Outcome Measure Information:
Title
National Institutes of Health Stroke Scale score
Description
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
Secondary Outcome Measure Information:
Title
Modified Rankin Scale score
Description
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
Title
Mortality
Description
Mortality at 90 days
Time Frame
90 days after stroke onset
Title
National Institutes of Health Stroke Scale score
Description
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
Title
National Institutes of Health Stroke Scale score
Description
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
Title
Telephonic Montreal Cognitive Assessment
Description
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
Title
Infarct size
Description
Infarct size at 72 hours (based on Magnetic resonance imaging measurements)
Time Frame
72 hours after stroke onset
Title
Blood glucose levels
Description
Blood glucose levels at days 1-7 (or until discharge)
Time Frame
Days 1-7 after stroke onset
Title
Blood pressure
Description
Blood pressure at days 1-7 (or until discharge)
Time Frame
Days 1-7 after stroke onset
Title
Body temperature
Description
Body temperature at days 1-7 (or until discharge)
Time Frame
Days 1-7 after stroke onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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), 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeannette Hofmeijer, MD, PhD
Phone
0880058877
Email
jhofmeijer@rijnstate.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Daphne van der Veen, MSc
Email
vascularsurgery@rijnstate.nl
Facility Information:
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renate Arntz
Email
Renate.Arntz@mst.nl
First Name & Middle Initial & Last Name & Degree
Renate Arntz
Facility Name
University Medical Center Utrecht
City
Utrecht
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bart van der Worp
Email
H.B.vanderWorp@umcutrecht.nl
First Name & Middle Initial & Last Name & Degree
Bart van der Worp
Facility Name
Isala
City
Zwolle
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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RCT of Ghrelin in Stroke Patients

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