Ischemic StrokeNCT05750303
Potential Prognostic Markers of Recovery in Post-stroke Rehabilitation
An observational study of Ischemic Stroke, run by Medical University of Lodz at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- How many people
- 32 participants
- Where
- 1 sitePoland
- Study dates
- 2 Jan 2022to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subacute ischemic stroke patients received standard therapy
Who may be able to join
- subacute ischeamic stroke,
- age over 18,
- informed consent obtained
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Ischemic Stroke
- Keywords
- stroke, recovery, biomarker, rehabilitation, VEGF, IGF-1, MMP-9
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subacute ischemic stroke | blood sample collection to determine VEGF, IGF-1 and MMP-9 level in plasma and expression of genes VEGF, IGF-1, MMP-9 in whole blood samples | |
| No ischemic stroke and no other neurological disease control group | blood sample collection to determine VEGF, IGF-1 and MMP-9 level in plasma and expression of genes VEGF, IGF-1, MMP-9 in whole blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 3 weeks later
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 -ΔCt
Measured: baseline and 3 weeks later
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.
Measured: baseline and 3 weeks later
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 -ΔCt
Measured: baseline and 3 weeks later
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.
Measured: baseline and 3 weeks later
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 -ΔCt
Measured: baseline and 3 weeks later
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
Measured: baseline and 3 weeks later
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
Measured: baseline and 3 weeks later
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.
Measured: baseline and 3 weeks later
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
Measured: baseline and 3 weeks later
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
Measured: baseline and 3 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start2 Jan 2022
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lodz
- Responsible party
- Sponsor
- Investigators
- Elzbieta Miller, Prof, Principal investigator, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750303
- Sponsor's protocol ID
- RNN/105/21/KE
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05750303
- Acronym / sponsor ID
- RNN/105/21/KE
- Conditions
- Ischemic Stroke
- Keywords
- stroke, recovery, biomarker, rehabilitation, VEGF, IGF-1, MMP-9
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Collaborators
- University of Lodz
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subacute ischemic stroke | – | –blood sample collection to determine VEGF, IGF-1 and MMP-9 level in plasma and expression of genes VEGF, IGF-1, MMP-9 in whole blood samples |
| No ischemic stroke and no other neurological disease control group | – | –blood sample collection to determine VEGF, IGF-1 and MMP-9 level in plasma and expression of genes VEGF, IGF-1, MMP-9 in whole blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subacute ischemic stroke patients received standard therapy
Key inclusion criteria (3 listed)
- subacute ischeamic stroke,
- age over 18,
- informed consent obtained
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
changes from baseline in IGF-1 level in plasma at 3 week of rehabilitation
Time frame: baseline and 3 weeks later
IGF-1 is a protein involved in neuroplasticity and angiogenesis processes. IGF-1 level in plasma - unit measure: ng/mL.
changes from baseline IGF-1 expression in whole blood sample at 3 week of rehabilitation
Time frame: baseline and 3 weeks later
IGF-1 is a protein involved in neuroplasticity and angiogenesis processes. IGF-1 mRNA gene expression is presented as -ΔCt
changes from baseline in VEGF level in plasma at 3 week of rehabilitation
Time frame: baseline and 3 weeks later
VEGF is a protein involved in neuroplasticity and angiogenesis processes. VEGF level in plasma - unit measure: pg/mL.
changes from baseline in VEGF expression in whole blood sample at 3 week of rehabilitation
Time frame: baseline and 3 weeks later
VEGF is a protein involved in neuroplasticity and angiogenesis processes. VEGF mRNA gene expression is presented as -ΔCt
changes from baseline in MMP-9 level in plasma at 3 week of rehabilitation
Time frame: baseline and 3 weeks later
MMP-9 is a protein involved in neuroplasticity and angiogenesis processes. MMP-9 level in plasma - unit of measure: pg/mL.
changes from baseline in MMP-9 expression in whole blood sample at 3 week of rehabilitation
Time frame: baseline and 3 weeks later
MMP-9 is a protein involved in neuroplasticity and angiogenesis processes. MMP-9 mRNA gene expression is presented as -ΔCt
changes form baseline in Mini Mental State Examination (MMSE) scale at 3-week rehabilitation
Time frame: baseline and 3 weeks later
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
changes form baseline in The Geriatric Depression Scale (GDS) at 3-week rehabilitation
Time frame: baseline and 3 weeks later
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
changes form baseline in Barthel index scale at 3-week rehabilitation
Time frame: baseline and 3 weeks later
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.
changes form baseline in National Institutes of Health Stroke Scale (NIHSS) scale at 3-week rehabilitation
Time frame: baseline and 3 weeks later
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
changes form baseline in Modified Rankin Scale (MRS) at 3-week rehabilitation
Time frame: baseline and 3 weeks later
Modified Rankin Scale measures degree of disability after stroke, ranges from grade 0 indicating a lack of symptoms to grade 6 indicating dead
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elzbieta Miller, Prof principal investigator
Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes from baseline in IGF-1 level in plasma at 3 week of rehabilitation (time frame: baseline and 3 weeks later). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.