StrokeNCT02409043
Neuronal and Glial Biomarkers in Stroke
An observational study of Stroke, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to determine if there are molecules in the blood that indicate when a person has had a stroke, and what type of stroke they have had, so that appropriate treatment may be begun as soon as possible. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Blood draw and Stroke blood draw
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals experiencing stroke symptoms who present at the University of Florida Shands Emergency Department or non-stroke control participants. These individuals will be invited to participate as study participants by a study representative within the first 24 hours after having a blood draw in the emergency department.
Who may be able to join
- Stroke, ischemic or hemorrhagic, is confirmed by clinical and/or imaging evidence
- For control participants, no acute or recent stroke
Who cannot join
- Onset of stroke symptoms cannot be confirmed to be less than 18 hours
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to determine if there are molecules in the blood that indicate when a person has had a stroke, and what type of stroke they have had, so that appropriate treatment may be begun as soon as possible. This study is also being conducted to determine whether these molecules can help to predict long-term health following stroke. Some of these potential molecules, also called biomarkers, include Neuronal biomarker ubiquitin C-terminal hydrolase-L1 (UCH-L1), Glial markers such as glial fibrillary acidic protein (GFAP), and a neuroprotective enzyme called angiotensin converting enzyme 2 (ACE2), which has activity that has been shown to be helpful cardiovascular disease and shown to be altered in animal models of acute stroke, where it is also shown to provide neuronal protection.
Read the detailed description
Research Plan Participants will be recruited from those presenting at Shands University of Florida (UF) hospital emergency room within the early hours after symptom onset, during which time a blood draw will be taken. Either in the emergency room, intensive care unit, or general hospital ward, a member of the study team will obtain informed consent for study participation within 24 hours of the first blood draw. The study team will provide the participant or legally authorized representative (LAR) with the consent form to read and will explain the study to the participant or LAR using the consent form as a guide. Time will be given to allow the participant or LAR to read the consent form and any questions will be answered. If the participant or LAR agrees to participate, then the study team member will have the participant sign the consent form and a copy of the signed form will be given for participants' records.
Study procedure: Information will be collected from medical records to determine the type and severity of stroke that the participant had and the time of stroke onset. Three 10cc samples of blood will be drawn from 90 participants with stroke (45 with ischemic stroke and 45 with hemorrhagic stroke). Samples of blood will also be drawn from 45 controls and 45 patients with stroke mimics, clinical symptoms that could be stroke but are determined to be due to another cause (e.g. transient ischemic attack). The first 10cc will be drawn within 18 hours of stroke onset and the second will be drawn 72 hours following stroke onset. The third will be obtained at the UF Neurology outpatient clinic 2-8 weeks after stroke. The first blood sample will be drawn during the initial evaluation in the ER prior to obtaining informed consent. This is due to the hectic ER environment and the need for the participant or LAR to be making serious medical decisions during this initial evaluation; factors which make this a non-ideal time to perform the informed consent process. The blood sample will then be stored using only the de-identified participant number for identification. Once the participant's condition has stabilized and no other serious medical decisions are being made, a study team member will approach the participant or LAR for the informed consent process as described above.
If the informed consent is obtained within 24 hours of obtaining the first blood sample then the participant will be enrolled in the study, the stored blood sample will be kept for further processing, the second and third blood samples will be drawn as previously described and testing for the aforementioned panel of biomarkers will be performed on the blood samples. If the participant or LAR declines to participate in the study or if informed consent is not obtained within 24 hours of the obtaining the first blood sample: 1) the stored blood sample will not be used for any purpose, 2) the stored blood sample will be completely destroyed within 24 hours of knowledge that the participant will not participate in the study and 3) no further blood samples will be obtained. Finally, participant's will be asked to complete a brief (less than 5 minute) phone survey 3 months after stroke to assess long-term stroke disability.
- Conditions
- Stroke
- Being tested
- Blood draw, Stroke blood draw
- Keywords
- Stroke, Ischemic stroke, Hemorrhagic stroke, Biomarkers, Angiotensins
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
Blood drawn for comparison with other groups
Stroke blood drawOther
Also called Information collection
Participants presenting at the University of Florida Shands Emergency Department with an ischemic stroke. Blood drawn at day 1, day 3, and at 2-8 weeks after stroke, NIH stroke scale scores, modified Rankin scale scores, blood pressure, MRI infarct volumes, and hospital length of stay taken from the medical records. 3 month modified Rankin scale score collected by phone interview.
| Study group | Role | What they receive |
|---|---|---|
| Control | Non-stroke participants. Blood drawn for analysis of biomarkers. Receives: Other: Blood draw | |
| Ischemic Stroke | Participants presenting at the University of Florida Shands Emergency Department with an ischemic stroke. Blood drawn at day 1, day 3, and at 2-8 weeks after stroke, NIH stroke scale scores, modified Rankin scale scores, and MRI infarct size assessed in hospital. 3 month modified Rankin scale score collected by phone interview. Receives: Other: Stroke blood draw | |
| Hemorrhagic Stroke | Participants presenting at the University of Florida Shands Emergency Department with an ischemic stroke. Blood drawn at day 1, day 3, and at 2-8 weeks after stroke, NIH stroke scale scores, modified Rankin scale scores, and MRI infarct size assessed in hospital. 3 month modified Rankin scale score collected by phone interview. Receives: Other: Stroke blood draw | |
| Stroke Mimic | Participants presenting at the University of Florida Shands Emergency Department with signs and symptoms resembling a stroke, but which are determined to be from another cause. Blood drawn during initial emergency room evaluation. Receives: Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Serum ACE2 Activity Levels
Serum and whole blood will be analyzed for levels of ACE2 activity. These markers will be assessed for their value as biomarkers of stroke subtype and long-term outcome.
Measured: Day 1
Subacute Serum ACE2 Activity Levels
Serum and whole blood will be analyzed for levels of ACE2 Activity.
Measured: Day 3
Follow-up Serum ACE2 Activity Levels
Serum and whole blood will be analyzed for levels of ACE2 Activity. This last time point will be assessed after discharge from the hospital at the time that the patient returns to the UF Neurology Clinic for their follow-up visit.
Measured: 8 weeks
Secondary outcomes (13)
Initial NIH Stroke Scale Score
NIH stroke scale scores will obtained as part of the normal care and are scored with points being assigned for neurological deficits (0 = best possible, highest number = best possible) in areas of motor control of the arm (0-4), leg (0-4) sensory perception (0-2), language (0-3), limb ataxia (0-2), gaze (0-2), level of consciousness (0-3), orientation (0-2), response to commands (0-2), facial palsy (0-3), visual (0-3), dysarthria (0-2), and extinction (0-2), and is used to assess the level of neurological deficit from the stroke.
Measured: Day 1
Recovery NIH Stroke Scale Score
NIH stroke scale scores will obtained as part of the normal care and are scored with points being assigned for neurological deficits (0 = best possible, highest number = best possible) in areas of motor control of the arm (0-4), leg (0-4) sensory perception (0-2), language (0-3), limb ataxia (0-2), gaze (0-2), level of consciousness (0-3), orientation (0-2), response to commands (0-2), facial palsy (0-3), visual (0-3), dysarthria (0-2), and extinction (0-2), and is used to assess the level of neurological deficit from the stroke.
Measured: Day 14
Initial infarct size from brain imaging studies
Infarct size will be measured as part of the normal care by MRI volumetric analysis in cm cubed and may range from less than a cm cubed to 20 cm cubed or greater depending on the extent of the stroke. This is meant to assess the size of the stroke.
Measured: Day 1
Recovery infarct size from brain imaging studies
Infarct size will be measured as part of the normal care by MRI volumetric analysis in cm cubed and may range from less than a cm cubed to 20 cm cubed or greater depending on the extent of the stroke. This is meant to assess the size of the stroke.
Measured: Day 14
Initial modified Rankin Score
Initial modified Rankin scale scores will be acquired in hospital as a part of the normal care and by a follow-up phone interview at 3 months. This is scored as follows:
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: Day 1
Recovery modified Rankin Score
Initial modified Rankin scale scores will be acquired in hospital as a part of the normal care and by a follow-up phone interview at 3 months. This is scored as follows:
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: Day 14
Long-term modified Rankin Score
Initial modified Rankin scale scores will be acquired in hospital as a part of the normal care and by a follow-up phone interview at 3 months. This is scored as follows:
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: 3 months
Acute Serum GFAP Levels
Serum and whole blood will be analyzed for levels of GFAP. These markers will be assessed for their value as biomarkers of stroke subtype and long-term outcome.
Measured: Day 1
Subacute Serum GFAP Levels
Serum and whole blood will be analyzed for levels of GFAP. These markers will be assessed for their value as biomarkers of stroke subtype and long-term outcome.
Measured: Day 3
Follow-up Serum GFAP Levels
Serum and whole blood will be analyzed for levels of GFAP. These markers will be assessed for their value as biomarkers of stroke subtype and long-term outcome. This last time point will be assessed after discharge from the hospital at the time that the patient returns to the UF Neurology Clinic for their follow-up visit.
Measured: 8 weeks
Acute Serum UCH-L1 Levels
Serum and whole blood will be analyzed for levels of UCH-L1. These markers will be assessed for their value as biomarkers of stroke subtype and long-term outcome.
Measured: Day 1
Subacute Serum UCH-L1 Levels
Serum and whole blood will be analyzed for levels of UCH-L1. These markers will be assessed for their value as biomarkers of stroke subtype and long-term outcome.
Measured: Day 3
Follow-up Serum UCH-L1 Levels
Serum and whole blood will be analyzed for levels of UCH-L1. These markers will be assessed for their value as biomarkers of stroke subtype and long-term outcome. This last time point will be assessed after discharge from the hospital at the time that the patient returns to the UF Neurology Clinic for their follow-up visit.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startJul 2014
- Primary completionDec 2015
- Study completionDec 2015
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 University of FloridaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harry Nick, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409043
- Sponsor's protocol ID
- IRB201200330
- Status last verified
- Sep 2017
- First submitted
- 2 Feb 2015
- Last updated
- 11 Sep 2017
- 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 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuronal and Glial Biomarkers in Stroke
- ClinicalTrials.gov ID
- NCT02409043
- Acronym / sponsor ID
- IRB201200330
- Conditions
- Stroke
- Keywords
- Stroke, Ischemic stroke, Hemorrhagic stroke, Biomarkers, Angiotensins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Apr 2015 (estimated)
- 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.
The purpose of this research study is to determine if there are molecules in the blood that indicate when a person has had a stroke, and what type of stroke they have had, so that appropriate treatment may be begun as soon as possible. This study is also being conducted to determine whether these molecules can help to predict long-term health following stroke. Some of these potential molecules, also called biomarkers, include Neuronal biomarker ubiquitin C-terminal hydrolase-L1 (UCH-L1), Glial markers such as glial fibrillary acidic protein (GFAP), and a neuroprotective enzyme called angiotensin converting enzyme 2 (ACE2), which has activity that has been shown to be helpful cardiovascular disease and shown to be altered in animal models of acute stroke, where it is also shown to provide neuronal protection.
Detailed description
Research Plan Participants will be recruited from those presenting at Shands University of Florida (UF) hospital emergency room within the early hours after symptom onset, during which time a blood draw will be taken. Either in the emergency room, intensive care unit, or general hospital ward, a member of the study team will obtain informed consent for study participation within 24 hours of the first blood draw. The study team will provide the participant or legally authorized representative (LAR) with the consent form to read and will explain the study to the participant or LAR using the consent form as a guide. Time will be given to allow the participant or LAR to read the consent form and any questions will be answered. If the participant or LAR agrees to participate, then the study team member will have the participant sign the consent form and a copy of the signed form will be given for participants' records.
Study procedure: Information will be collected from medical records to determine the type and severity of stroke that the participant had and the time of stroke onset. Three 10cc samples of blood will be drawn from 90 participants with stroke (45 with ischemic stroke and 45 with hemorrhagic stroke). Samples of blood will also be drawn from 45 controls and 45 patients with stroke mimics, clinical symptoms that could be stroke but are determined to be due to another cause (e.g. transient ischemic attack). The first 10cc will be drawn within 18 hours of stroke onset and the second will be drawn 72 hours following stroke onset. The third will be obtained at the UF Neurology outpatient clinic 2-8 weeks after stroke. The first blood sample will be drawn during the initial evaluation in the ER prior to obtaining informed consent. This is due to the hectic ER environment and the need for the participant or LAR to be making serious medical decisions during this initial evaluation; factors which make this a non-ideal time to perform the informed consent process. The blood sample will then be stored using only the de-identified participant number for identification. Once the participant's condition has stabilized and no other serious medical decisions are being made, a study team member will approach the participant or LAR for the informed consent process as described above.
If the informed consent is obtained within 24 hours of obtaining the first blood sample then the participant will be enrolled in the study, the stored blood sample will be kept for further processing, the second and third blood samples will be drawn as previously described and testing for the aforementioned panel of biomarkers will be performed on the blood samples. If the participant or LAR declines to participate in the study or if informed consent is not obtained within 24 hours of the obtaining the first blood sample: 1) the stored blood sample will not be used for any purpose, 2) the stored blood sample will be completely destroyed within 24 hours of knowledge that the participant will not participate in the study and 3) no further blood samples will be obtained. Finally, participant's will be asked to complete a brief (less than 5 minute) phone survey 3 months after stroke to assess long-term stroke disability.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Blood drawNon-stroke participants. Blood drawn for analysis of biomarkers. |
| Ischemic Stroke | – | Other: Stroke blood drawParticipants presenting at the University of Florida Shands Emergency Department with an ischemic stroke. Blood drawn at day 1, day 3, and at 2-8 weeks after stroke, NIH stroke scale scores, modified Rankin scale scores, and MRI infarct size assessed in hospital. 3 month modified Rankin scale score collected by phone interview. |
| Hemorrhagic Stroke | – | Other: Stroke blood drawParticipants presenting at the University of Florida Shands Emergency Department with an ischemic stroke. Blood drawn at day 1, day 3, and at 2-8 weeks after stroke, NIH stroke scale scores, modified Rankin scale scores, and MRI infarct size assessed in hospital. 3 month modified Rankin scale score collected by phone interview. |
| Stroke Mimic | – | Other: Blood drawParticipants presenting at the University of Florida Shands Emergency Department with signs and symptoms resembling a stroke, but which are determined to be from another cause. Blood drawn during initial emergency room evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals experiencing stroke symptoms who present at the University of Florida Shands Emergency Department or non-stroke control participants. These individuals will be invited to participate as study participants by a study representative within the first 24 hours after having a blood draw in the emergency department.
Key inclusion criteria (2 listed)
- Stroke, ischemic or hemorrhagic, is confirmed by clinical and/or imaging evidence
- For control participants, no acute or recent stroke
Key exclusion criteria (1 listed)
- Onset of stroke symptoms cannot be confirmed to be less than 18 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawBlood drawn for comparison with other groups | Other | Control, Stroke Mimic |
| Stroke blood drawAlso: Information collectionParticipants presenting at the University of Florida Shands Emergency Department with an ischemic stroke. Blood drawn at day 1, day 3, and at 2-8 weeks after stroke, NIH stroke scale scores, modified Rankin scale scores, blood pressure, MRI infarct volumes, and hospital length of stay taken from the medical records. 3 month modified Rankin scale score collected by phone interview. | Other | Hemorrhagic Stroke, Ischemic Stroke |
Primary outcome
Acute Serum ACE2 Activity Levels
Time frame: Day 1
Serum and whole blood will be analyzed for levels of ACE2 activity. These markers will be assessed for their value as biomarkers of stroke subtype and long-term outcome.
Subacute Serum ACE2 Activity Levels
Time frame: Day 3
Serum and whole blood will be analyzed for levels of ACE2 Activity.
Follow-up Serum ACE2 Activity Levels
Time frame: 8 weeks
Serum and whole blood will be analyzed for levels of ACE2 Activity. This last time point will be assessed after discharge from the hospital at the time that the patient returns to the UF Neurology Clinic for their follow-up visit.
13 secondary outcomes
Initial NIH Stroke Scale Score
Time frame: Day 1
Recovery NIH Stroke Scale Score
Time frame: Day 14
Initial infarct size from brain imaging studies
Time frame: Day 1
Recovery infarct size from brain imaging studies
Time frame: Day 14
Initial modified Rankin Score
Time frame: Day 1
Recovery modified Rankin Score
Time frame: Day 14
Long-term modified Rankin Score
Time frame: 3 months
Acute Serum GFAP Levels
Time frame: Day 1
Subacute Serum GFAP Levels
Time frame: Day 3
Follow-up Serum GFAP Levels
Time frame: 8 weeks
Acute Serum UCH-L1 Levels
Time frame: Day 1
Subacute Serum UCH-L1 Levels
Time frame: Day 3
Follow-up Serum UCH-L1 Levels
Time frame: 8 weeks
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 11 Sep 2017.
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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.
Harry Nick, PhD principal investigator
University of Florida
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 University of Florida at 1 site in United States.
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 1 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 11 Sep 2017. 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 United States. 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?
Acute Serum ACE2 Activity Levels (time frame: Day 1). The study lists 3 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 11 Sep 2017.