Ghrelintrial With Patients With Stroke

NCT03264742 | Terminated DMC

• 1 other identifier: ID 2017-00387
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

DEMMMI, Nine-Hole-PEG-Test, mRS; Stroke, Acute

Keywords

ghreline, stroke

Outcome Measures

Primary Outcomes (1)

• De Morton Mobility Index (DEMMI)

  The de Morton Mobility Index (DEMMI) is an internationally well-established, unidimensional measure of mobility with good psychometric properties.

  On the first, the third day and 3 months after including in the study, the time for the DEMMI takes about 20 minutes

Interventions

Ghrelin OTHER

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kantonsspital Winterthur KSW: lead

Study Sites (1)

Kantonsspital Winterthur

Winterthur, 8400, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 16859720 BACKGROUND

• 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.

  PMID: 24961317 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Ghrelin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Peter Ballmer

  Kantonsspital Winterthur KSW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 29, 2017
• Study Start: April 1, 2017
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: March 1, 2019

Record last verified: 2019-02

Locations

CH (1)