Potential Prognostic Markers of Recovery in Post-stroke Rehabilitation

Ischemic Stroke Clinical Trial

Official title:

Circulating Serum VEGF, IGF-1 and MMP-9 and Expression of Their Genes as Potential Prognostic Markers of Recovery in Post-stroke Rehabilitation - Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05750303
• Other study ID #: RNN/105/21/KE
• Status: Completed
• Start date: January 2, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: Medical University of Lodz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Despite increasingly effective early treatment strategies for ischemic stroke, post-stroke recovery is often incomplete and depend on spontaneous and therapeutic-induced processes related to neuroplasticity, angiogenesis and reperfusion. These processes are regulated by growth factors, neurotrophines, neurotransmitters, hormones and other factors. This study aims to search biomarkers that prognose brain repair ability and consequently estimate an outcome of stroke patients. The prognostic value of proteins VEGF, IGF-1 and MMP-9 and expression of genes VEGF, IGF-1, MMP-9 is evaluated in association with clinical scales including cognitive assessment scales and depression scales. Blood sample collection as well as scales recording are taken at baseline and 3 weeks later after rehabilitation.

Description:

Despite increasingly effective early treatment strategies for ischemic stroke, post-stroke recovery is often incomplete and depend on spontaneous and therapeutic-induced processes related to neuroplasticity, angiogenesis and reperfusion. These processes are regulated by growth factors, neurotrophines, neurotransmitters, hormones and other factors. Recovery activity can be reflected both in the clinical assessment of the patient (based on the NIHSS or MRS scale for example) as well as on the biochemical and molecular level. This study aims to search biomarkers that prognose brain repair ability and consequently estimate an outcome of stroke patients. The prognostic value of proteins VEGF, IGF-1 and MMP-9 and expression of genes VEGF, IGF-1, MMP-9 is evaluated in association with clinical scales including cognitive assessment scales and depression scales. Furthermore, the collected data will be analyzed in relation to demographics and vascular risk factors. Blood sample collection as well as scales recording are taken at baseline and 3 weeks later after rehabilitation. The study group patients will undergo standard post-stroke rehabilitation programme provided by physiotherapist, every day for a period of 3 weeks with weekend gaps.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• subacute ischeamic stroke,

• age over 18,

• informed consent obtained

Exclusion Criteria:

• intracerebral haemorrhage,

• chronic or significant acute inflammatory factors,

• neurological illness other than ischeamic stroke,

• severe cardio-vascular disease like myocardial infarction less than 30 days, unstable angina pectoris,

• decompensated metabolic or endocrine diseases

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
Poland	Medical University of Lodz	Lodz

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Lodz	University of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes from baseline in IGF-1 level in plasma at 3 week of rehabilitation	IGF-1 is a protein involved in neuroplasticity and angiogenesis processes. IGF-1 level in plasma - unit measure: ng/mL.	baseline and 3 weeks later
Primary	changes from baseline IGF-1 expression in whole blood sample at 3 week of rehabilitation	IGF-1 is a protein involved in neuroplasticity and angiogenesis processes. IGF-1 mRNA gene expression is presented as -?Ct	baseline and 3 weeks later
Primary	changes from baseline in VEGF level in plasma at 3 week of rehabilitation	VEGF is a protein involved in neuroplasticity and angiogenesis processes. VEGF level in plasma - unit measure: pg/mL.	baseline and 3 weeks later
Primary	changes from baseline in VEGF expression in whole blood sample at 3 week of rehabilitation	VEGF is a protein involved in neuroplasticity and angiogenesis processes. VEGF mRNA gene expression is presented as -?Ct	baseline and 3 weeks later
Primary	changes from baseline in MMP-9 level in plasma at 3 week of rehabilitation	MMP-9 is a protein involved in neuroplasticity and angiogenesis processes. MMP-9 level in plasma - unit of measure: pg/mL.	baseline and 3 weeks later
Primary	changes from baseline in MMP-9 expression in whole blood sample at 3 week of rehabilitation	MMP-9 is a protein involved in neuroplasticity and angiogenesis processes. MMP-9 mRNA gene expression is presented as -?Ct	baseline and 3 weeks later
Primary	changes form baseline in Mini Mental State Examination (MMSE) scale at 3-week rehabilitation	Mini Mental State Examination is effective, screening tool for cognitive impairment, the maximum score for the MMSE is 30, a cut-off score of 23/24 (or below) indicates dementia, a score of 25 or higher is classed as normal	baseline and 3 weeks later
Primary	changes form baseline in The Geriatric Depression Scale (GDS) at 3-week rehabilitation	The Geriatric Depression Scale is self-reported validated measure of depression in older adults, consists of 15 questions, users respond in a "Yes/No" format, scores 0-4 are considered normal, more than 5 indicate depression: 5-8 mild, 9-11 moderate and 12-15 severe depressive symptoms	baseline and 3 weeks later
Primary	changes form baseline in Barthel index scale at 3-week rehabilitation	Barthel index is a scale used to measure performance in activities of daily living, the 10 items including the Barthel Index pay attention to self-care and mobility. Total possible scores range from 0 - 20, with lower scores indicating increased disability, a score of 17 represents normal ability.	baseline and 3 weeks later
Primary	changes form baseline in National Institutes of Health Stroke Scale (NIHSS) scale at 3-week rehabilitation	National Institutes of Health Stroke Scale is a tool used to objectively quantify the impairment caused by stroke,total score ranging from 0 to 42 and the higher the score, the more severe the stroke	baseline and 3 weeks later
Primary	changes form baseline in Modified Rankin Scale (MRS) at 3-week rehabilitation	Modified Rankin Scale measures degree of disability after stroke, ranges from grade 0 indicating a lack of symptoms to grade 6 indicating dead	baseline and 3 weeks later