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Ghrelintrial With Patients With Stroke

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ClinicalTrials.gov Identifier: NCT03264742
Recruitment Status : Terminated (recruitment too low)
First Posted : August 29, 2017
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Kantonsspital Winterthur KSW

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.

Condition or disease Intervention/treatment
DEMMMI, Nine-Hole-PEG-Test, mRS Stroke, Acute Other: Ghrelin

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


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Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Trial to Investigate a Neuroprotective Effect of Ghrelin After Acute Ischemic Stroke
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019

Intervention Details:
  • Other: Ghrelin
    The patients are assigned within the scope of the admission according to emergency to the treatment and clarification on the Stroke Unit of the KSW. There the patients are enclosed in the study and are examined according to the draught on the Stroke Unit within the scope of the complex treatment. The inclusion of the patients occurs after clarification and in the consent of the patients. In the morning after the admission day the decrease of the first blood test occurs within the scope of the blood sample as a matter of routine to be carried out for the Ghrelinbestimmung. Also 48 H occurs after the first withdrawal and 3 months after the stroke a blood sample to the regulation of Ghrelin.


Primary Outcome Measures :
  1. De Morton Mobility Index (DEMMI) [ Time Frame: On the first, the third day and 3 months after including in the study, the time for the DEMMI takes about 20 minutes ]
    The de Morton Mobility Index (DEMMI) is an internationally well-established, unidimensional measure of mobility with good psychometric properties.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03264742


Locations
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Switzerland
Kantonsspital Winterthur
Winterthur, Switzerland, 8400
Sponsors and Collaborators
Kantonsspital Winterthur KSW
Investigators
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Principal Investigator: Peter Ballmer Kantonsspital Winterthur KSW

Publications:
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Responsible Party: Kantonsspital Winterthur KSW
ClinicalTrials.gov Identifier: NCT03264742     History of Changes
Other Study ID Numbers: ID 2017-00387
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kantonsspital Winterthur KSW:
ghreline, stroke

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases