StrokeNCT05812846
Monitoring of the Ischemic Stroke Patient Through the Use of New Serum Biomarkers and MRI Imaging
An observational study of Stroke, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
Aim of this study will be the evaluation (by ELISA quantification and quantitative RT-PCR) of circulating biomarkers of damage and regeneration in patients affected by ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- How many people
- 135 participants
- Where
- 1 siteItaly
- Study dates
- 4 Dec 2018to 3 Jun 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with minor/moderate/severe stroke
Who may be able to join
- First occurrence of brain injury, confirmed on CT imaging, determined by ischemic stroke
- Patient able to sign an informed consent, alternatively legal representative or relative
Who cannot join
- Previous ischemic events
- Previous head trauma of any entity
- New onset of acute events during the study
- Previous illness, diagnosis or suspicion of current illness with central nervous system involvement
- Diagnosis of cognitive impairment prior to the acute event (MMSE < 24)
- Need for walking assistance prior to the acute event
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- Diagnosis of autoimmune diseases
- Diagnosis of haematological or oncological disease
- Diagnosis of a psychiatric condition: bipolar disorder, psychosis, schizophrenia or suicidal ideation
- Subjects with relative and absolute contraindications to magnetic resonance imaging.
- Life expectancy less than 1 year
- Dependence or abuse of alcohol, drugs or psychotropics prior to the acute event
- Pregnancy in progress
- Severe renal or hepatic insufficiency (Renal disease > II stage, Child-Plugh score >5)
Trial locations and contacts
1 site in 1 country.
About this study
Aim of this study will be the evaluation (by ELISA quantification and quantitative RT-PCR) of circulating biomarkers of damage and regeneration in patients affected by ischemic stroke. The biomarker levels will be measured from the acute event (48h) and in subsequent 4 times (7 days, 30 days, 90 days, 180 days) following hospitalization, up to 6 months after the acute event. These data will then be correlated for all five times with the clinical scales normally used for patient evaluation and will also be associated with MRI-DTI measurements performed in the post-acute (30 days) and post-discharge (180 days) phase.
Read the detailed description
In current clinical practice, outcome's assessment after stroke and patients' monitoring during rehabilitation rely on scores in clinical scales and instrumental evaluations (electrophysiological evaluations and MRI imaging). This approach follows current guidelines but has some limitations:
- subjectivity of the patient's clinical evaluation and instrumental data's interpretation
- poor prognostic value of clinical scales;
- poor prognostic value of instrumental measurements;
- difficulty in standardizing and automating clinical/instrumental assessments;
- difficulty in evaluating medical services on a large scale due to the lack of discrete values of treatment efficacy.
The identification and validation of reliable and accessible biomarkers associated with patients' functional recovery could improve their care but still remains a clinical challenge.
Aim of this study will be to measure the levels of circulating biomarkers of brain damage and regeneration in patients affected by ischemic stroke, and to evaluate their prognostic relevance over a 6-month follow-up. Biomarkers' levels will be measured by ELISA and quantitative RT-PCR from the acute event (within 24h from symptoms onset) and in subsequent 4 time-points (7 days, 30 days, 90 days, 180 days post-stroke). Obtained data will be correlated with clinical scales used for patient evaluation and will be associated with MRI-DTI measurements performed in the post-acute (30 days) and post-discharge (180 days) phase.
- Conditions
- Stroke
- Keywords
- stroke, biomarkers
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating/neuroimaging biomarkers and GCS
Correlation between circulating/neuroimaging biomarkers (GFAP as the only biomarker of brain damage, BDNF and VEGF as markers of neuronal regeneration and plasticity) and functional recovery expressed by Glasgow Coma Scale (GCS)
Measured: 54 months
Circulating/neuroimaging biomarkers and NIHSS
Correlation between circulating/neuroimaging biomarkers (GFAP as the only biomarker of brain damage, BDNF and VEGF as markers of neuronal regeneration and plasticity) and functional recovery expressed by NIHSS scale
Measured: 54 months
Circulating/neuroimaging biomarkers and mRS
Correlation between circulating/neuroimaging biomarkers (GFAP as the only biomarker of brain damage, BDNF and VEGF as markers of neuronal regeneration and plasticity) and functional recovery expressed by modified Rankin Scale (mRS)
Measured: 54 months
Circulating/neuroimaging biomarkers and Functional Ambulation Classification
Correlation between circulating/neuroimaging biomarkers (GFAP as the only biomarker of brain damage, BDNF and VEGF as markers of neuronal regeneration and plasticity) and functional recovery expressed by Functional Ambulation Classification
Measured: 54 months
Circulating/neuroimaging biomarkers and Ashworth scale
Correlation between circulating/neuroimaging biomarkers (GFAP as the only biomarker of brain damage, BDNF and VEGF as markers of neuronal regeneration and plasticity) and functional recovery expressed by Ashworth scale
Measured: 54 months
Circulating/neuroimaging biomarkers and MMSE
Correlation between circulating/neuroimaging biomarkers (GFAP as the only biomarker of brain damage, BDNF and VEGF as markers of neuronal regeneration and plasticity) and functional recovery expressed by MMSE scale
Measured: 54 months
Secondary outcomes (1)
Biomarker curve trend
Estimation of the impact of rehabilitation treatment on the trend of the biomarker curve in patients with ischemic stroke, i.e. how GFAP changes in time after treatment (comparison of GFAP levels between times)
Measured: 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start4 Dec 2018
- Primary completion3 Jun 2023
- Study completion3 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812846
- Sponsor's protocol ID
- 2250
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 21 Jul 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 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of the Ischemic Stroke Patient Through the Use of New Serum Biomarkers and MRI Imaging
- ClinicalTrials.gov ID
- NCT05812846
- Acronym / sponsor ID
- 2250
- Conditions
- Stroke
- Keywords
- stroke, biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 3 Jun 2023 (actual)
- Study completion
- 3 Jun 2023 (actual)
- First posted
- 14 Apr 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.
Aim of this study will be the evaluation (by ELISA quantification and quantitative RT-PCR) of circulating biomarkers of damage and regeneration in patients affected by ischemic stroke. The biomarker levels will be measured from the acute event (48h) and in subsequent 4 times (7 days, 30 days, 90 days, 180 days) following hospitalization, up to 6 months after the acute event. These data will then be correlated for all five times with the clinical scales normally used for patient evaluation and will also be associated with MRI-DTI measurements performed in the post-acute (30 days) and post-discharge (180 days) phase.
Detailed description
In current clinical practice, outcome's assessment after stroke and patients' monitoring during rehabilitation rely on scores in clinical scales and instrumental evaluations (electrophysiological evaluations and MRI imaging). This approach follows current guidelines but has some limitations:
- subjectivity of the patient's clinical evaluation and instrumental data's interpretation
- poor prognostic value of clinical scales;
- poor prognostic value of instrumental measurements;
- difficulty in standardizing and automating clinical/instrumental assessments;
- difficulty in evaluating medical services on a large scale due to the lack of discrete values of treatment efficacy.
The identification and validation of reliable and accessible biomarkers associated with patients' functional recovery could improve their care but still remains a clinical challenge.
Aim of this study will be to measure the levels of circulating biomarkers of brain damage and regeneration in patients affected by ischemic stroke, and to evaluate their prognostic relevance over a 6-month follow-up. Biomarkers' levels will be measured by ELISA and quantitative RT-PCR from the acute event (within 24h from symptoms onset) and in subsequent 4 time-points (7 days, 30 days, 90 days, 180 days post-stroke). Obtained data will be correlated with clinical scales used for patient evaluation and will be associated with MRI-DTI measurements performed in the post-acute (30 days) and post-discharge (180 days) phase.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with minor/moderate/severe stroke
Key inclusion criteria (2 listed)
- First occurrence of brain injury, confirmed on CT imaging, determined by ischemic stroke
- Patient able to sign an informed consent, alternatively legal representative or relative
Key exclusion criteria (14 listed)
- Previous ischemic events
- Previous head trauma of any entity
- New onset of acute events during the study
- Previous illness, diagnosis or suspicion of current illness with central nervous system involvement
- Diagnosis of cognitive impairment prior to the acute event (MMSE < 24)
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
Circulating/neuroimaging biomarkers and GCS
Time frame: 54 months
Correlation between circulating/neuroimaging biomarkers (GFAP as the only biomarker of brain damage, BDNF and VEGF as markers of neuronal regeneration and plasticity) and functional recovery expressed by Glasgow Coma Scale (GCS)
Circulating/neuroimaging biomarkers and NIHSS
Time frame: 54 months
Correlation between circulating/neuroimaging biomarkers (GFAP as the only biomarker of brain damage, BDNF and VEGF as markers of neuronal regeneration and plasticity) and functional recovery expressed by NIHSS scale
Circulating/neuroimaging biomarkers and mRS
Time frame: 54 months
Correlation between circulating/neuroimaging biomarkers (GFAP as the only biomarker of brain damage, BDNF and VEGF as markers of neuronal regeneration and plasticity) and functional recovery expressed by modified Rankin Scale (mRS)
Circulating/neuroimaging biomarkers and Functional Ambulation Classification
Time frame: 54 months
Correlation between circulating/neuroimaging biomarkers (GFAP as the only biomarker of brain damage, BDNF and VEGF as markers of neuronal regeneration and plasticity) and functional recovery expressed by Functional Ambulation Classification
Circulating/neuroimaging biomarkers and Ashworth scale
Time frame: 54 months
Correlation between circulating/neuroimaging biomarkers (GFAP as the only biomarker of brain damage, BDNF and VEGF as markers of neuronal regeneration and plasticity) and functional recovery expressed by Ashworth scale
Circulating/neuroimaging biomarkers and MMSE
Time frame: 54 months
Correlation between circulating/neuroimaging biomarkers (GFAP as the only biomarker of brain damage, BDNF and VEGF as markers of neuronal regeneration and plasticity) and functional recovery expressed by MMSE scale
1 secondary outcome
Biomarker curve trend
Time frame: 54 months
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 21 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stroke, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
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 2 inclusion and 14 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 21 Jul 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 Italy. 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?
Circulating/neuroimaging biomarkers and GCS (time frame: 54 months). The study lists 6 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 21 Jul 2023.