Clinical trial NCT03264742: Ghrelintrial With Patients With Stroke
Official title: Longitudinal Trial to Investigate a Neuroprotective Effect of Ghrelin After Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: DEMMMI, Nine-Hole-PEG-Test, mRS
Stroke, Acute
Keywords: ghreline, stroke
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female patients with acute ischemic insult with functionally relevant motor Hemisymptomatik up to 7 days after the event at the age from 18 to 90 years with written approval of the participant after occurred clarification

Brief summary: Patients are assigned to KSW's Stroke Unit as part of the emergency treatment. There the patients are included in the study and treated according to the concept on the Stroke Unit within the complex treatment. The patients are included after clarification and with the consent of the patients. On the morning after the day of intake, the first determination of the ghrelin takes place in the routine blood sampling. Similarly, 48 hours later and 3 months after the stroke, a blood sampling is performed to determine ghrelin. The De Morton Mobility Index (DEMMI), the 9-hole-peg assay and the modified Rankin Scale (mRS) are determined on the day of admission, on the 3rd day, and three months after stroke. This is done within the framework of the routine clarification and treatment on the Stroke Unit.

Detailed description: Ghreline is a peptide hormone which is produced particularly by cells of the stomach mucous membrane and has an appetizing effect. Nevertheless, the last studies in the person as well as in the animal model showed that ghreline as well as receptos of ghreline become exprimated also in neurons. Antiapoptic effects of ghreline, an increase of the endogenous neuro genesis and support of the formation of dendritic synapses could be proved. In a study in the animal model (rats), for example, a neuroprotective effect from ghreline could be proved. Besides, ghreline showed neuro-regenerative effects after a stroke. As a possible mechanism an increased neuro genesis is accepted for this. Now the aim of our study is to be examined whether the patients with an ischemic stroke who have a high ghreline concentration have a better functional outcome. No interventions specific for study take place. It concerns with this research project not a clinical attempt, but a pure blood withdrawal plus survey. Besides, no special risks exist for the patient, because it is found in the routine treatment on the stroke station (Stroke Unit) of the canton hospital of Winterthur and no measures specific for study are carried out.

aims of Project: The aim of this study is to examine Ghrelin concerning his neuroprotective and neuro-regenerative improvement of patients with acute stroke.

Aim dimensions of the project Improvement of the functional Outcomes with patients with acute stroke measured in the De Morton Mobility Index (DEMMI), 9hole-peg-Test and the modified Rankin-Scale (mRS) in relation to the ghreline-serum concentration. In the morning after the admission day the decrease of the first Ghrelintest occurs within the scope of the blood sample as a matter of routine to be carried out. Also 48 hours later and 3 months after the blow attack a blood sample for testing the ghreline concentration is taken as a mater of routine.

The patients are recruited within the scope of the treatment on the stroke station of the canton hospital of Winterthur Duration of the project 2 Years intended time of the beginning of the project (FPFV): 01/09/2016 prospective time of the end of the project (LPLV): 31/08/2018 The Stroke Unit (stroke station) of the canton hospital of Winterthur exists since 01.04. 2013 and looks meanwhile yearly after more than 400 patients with cerebrovaskulären illnesses. To the-chance a qualified and experienced nursing staff stands beside the medical care, neuro-logically experienced therapists as well as a suitable infrastructure which enables to raise the data necessary for the study qualitatively on the highest level

Eligibility criteria: Inclusion Criteria:

* Male and female patients
* acute ischemic insult
* functionally relevant motor hemisymptomatic
* up to 7 days after the event
* age from 18 to 90 years
* written approval of the participant after occurred clarification

Exclusion Criteria:

* Dysphagia
* Nutritional-Risk-Screening (NRS) = 3
* Neuro-degenerative illnesses
* Patients with strokes in the past
* Patients with clinically relevant Polyneuropathy
* Patients with walking disturbance on account of mikroangiopathic changes
* Patients with psychiatric preillnesses (depression, schizophrenia) and anti- depressive and neuroleptic medication
* Patients with rheumatic illnesses with effects on the walking and Hand function
* Patients with innate and/or acquired substance defects of the brain and/or spinal cord (functionally relevant brain tumour, St. n. Encephalitis, brain damage as an infant)

Primary outcomes:
measure: De Morton Mobility Index (DEMMI)
timeFrame: On the first, the third day and 3 months after including in the study, the time for the DEMMI takes about 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
Study officials:
affiliation: Kantonsspital Winterthur KSW
name: Peter Ballmer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cummings DE. Ghrelin and the short- and long-term regulation of appetite and body weight. Physiol Behav. 2006 Aug 30;89(1):71-84. doi: 10.1016/j.physbeh.2006.05.022. Epub 2006 Jul 21.
citation: Spencer SJ, Miller AA, Andrews ZB. The role of ghrelin in neuroprotection after ischemic brain injury. Brain Sci. 2013 Mar 19;3(1):344-59. doi: 10.3390/brainsci3010344.