Clinical trial NCT05750303: Potential Prognostic Markers of Recovery in Post-stroke Rehabilitation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Keywords: stroke
recovery
biomarker
rehabilitation
VEGF
IGF-1
MMP-9
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
Collaborators: name: University of Lodz
First posted: 2023-03-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subacute ischemic stroke patients received standard therapy

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: changes from baseline in IGF-1 level in plasma at 3 week of rehabilitation
timeFrame: baseline and 3 weeks later
measure: changes from baseline IGF-1 expression in whole blood sample at 3 week of rehabilitation
timeFrame: baseline and 3 weeks later
measure: changes from baseline in VEGF level in plasma at 3 week of rehabilitation
timeFrame: baseline and 3 weeks later
measure: changes from baseline in VEGF expression in whole blood sample at 3 week of rehabilitation
timeFrame: baseline and 3 weeks later
measure: changes from baseline in MMP-9 level in plasma at 3 week of rehabilitation
timeFrame: baseline and 3 weeks later
measure: changes from baseline in MMP-9 expression in whole blood sample at 3 week of rehabilitation
timeFrame: baseline and 3 weeks later
measure: changes form baseline in Mini Mental State Examination (MMSE) scale at 3-week rehabilitation
timeFrame: baseline and 3 weeks later
measure: changes form baseline in The Geriatric Depression Scale (GDS) at 3-week rehabilitation
timeFrame: baseline and 3 weeks later
measure: changes form baseline in Barthel index scale at 3-week rehabilitation
timeFrame: baseline and 3 weeks later
measure: changes form baseline in National Institutes of Health Stroke Scale (NIHSS) scale at 3-week rehabilitation
timeFrame: baseline and 3 weeks later
measure: changes form baseline in Modified Rankin Scale (MRS) at 3-week rehabilitation
timeFrame: baseline and 3 weeks later
Secondary outcomes:
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Medical University of Lodz
Study officials:
affiliation: Medical University of Lodz
name: Elzbieta Miller, Prof
role: PRINCIPAL_INVESTIGATOR
References: