Acute Ischemic StrokeNCT02297984
Serum Neuroglobin and HIF-1α in Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
Neuroglobin has shown rich neuroprotective effects against cerebral ischemia and hypoxia, and therefore has the potential to impact outcomes after acute ischemic stroke. Hypoxia inducible factor (HIF)-1α is neuroprotective in several models of experimental brain injury and is increased in brain after acute cerebral… Read more about this study
- Who is it for?
- Ages 42 to 76 years
- Conditions the study is for
- Acute Ischemic Stroke
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Oct 2014
- How long will I take part?
- 3 Months
- 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 42 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient group comprised 24 male and 16 female. Their age ranged from 42 to 76 years. Locations of infarct, as evidenced by radiologic and neurologic symptoms or signs, included the territories of the middle cerebral artery (13 cases), the posterior cerebral artery (9 cases) the anterior cerebral artery (8 cases), vertebrobasilar area (7 cases), and watershed area (3 cases with cortical and subcortical low densities crossing typical vascular territories).
Who may be able to join
- Clinical diagnosis of acute ischemic stroke
- Admission within 12 hours
Who cannot join
- Lacunar infarction
- Cerebral hemorrhagic infarction
- Epilepsy or epileptic persons
- History of neurological diseases, myocardial infarction, renal and hepatic abnormalities and metabolic diseases
- Contraindications to antiplatelet treatments
- Serial blood samples could not be obtained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes of Serum Neuroglobin and HIF-1α Concentrations in Early-phase of Acute Ischemic Stroke
Neuroglobin has shown rich neuroprotective effects against cerebral ischemia and hypoxia, and therefore has the potential to impact outcomes after acute ischemic stroke. Hypoxia inducible factor (HIF)-1α is neuroprotective in several models of experimental brain injury and is increased in brain after acute cerebral infarction in humans and experimental animals.The investigators sought to examine the changes in serum neuroglobin and HIF-1α concentrations in patients with acute ischemic stroke during the initial 96-h period after stroke and assessed the relation between them and the relation of them to prognosis of such patients with acute ischemic stroke.
- Conditions
- Acute Ischemic Stroke
- Keywords
- Neuroglobin, HIF-α, Acute ischemic stroke, Prognosis
- Medical subject headings
- Ischemic 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 |
|---|---|---|
| Acute ischemic stroke | Patients who suffered from acute ischemic stroke within 12 hours for the first time before entry into the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale scores
0 = No symptoms; 1 = No significant disability. Able to carry out all usual activities, despite some symptoms; 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3 = Moderate disability. Requires some help, but able to walk unassisted; 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6 = Dead.
Measured: 3 months
Secondary outcomes (1)
Glasgow Outcome Scale scores
Glasgow Outcome Scale 1 = death; Glasgow Outcome Scale 2 = vegetative state; Glasgow Outcome Scale 3 = severe neurological deficit; Glasgow Outcome Scale 4 = mild neurological deficit and Glasgow Outcome Scale 5 = premorbid level of functioning or completely recovery.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Chen, Shanghai 6th People's Hospital
- Investigators
- Lixia Xue, M.D., Ph.D., Study director, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297984
- Sponsor's protocol ID
- H1583-660145
- Status last verified
- Aug 2020
- First submitted
- 19 Nov 2014
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Serum Neuroglobin and HIF-1α Concentrations in Early-phase of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02297984
- Acronym / sponsor ID
- H1583-660145
- Conditions
- Acute Ischemic Stroke
- Keywords
- Neuroglobin, HIF-α, Acute ischemic stroke, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 21 Nov 2014 (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.
Neuroglobin has shown rich neuroprotective effects against cerebral ischemia and hypoxia, and therefore has the potential to impact outcomes after acute ischemic stroke. Hypoxia inducible factor (HIF)-1α is neuroprotective in several models of experimental brain injury and is increased in brain after acute cerebral infarction in humans and experimental animals.The investigators sought to examine the changes in serum neuroglobin and HIF-1α concentrations in patients with acute ischemic stroke during the initial 96-h period after stroke and assessed the relation between them and the relation of them to prognosis of such patients with acute ischemic stroke.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic stroke | – | –Patients who suffered from acute ischemic stroke within 12 hours for the first time before entry into the study. |
Who may qualify
- Ages
- 42 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient group comprised 24 male and 16 female. Their age ranged from 42 to 76 years. Locations of infarct, as evidenced by radiologic and neurologic symptoms or signs, included the territories of the middle cerebral artery (13 cases), the posterior cerebral artery (9 cases) the anterior cerebral artery (8 cases), vertebrobasilar area (7 cases), and watershed area (3 cases with cortical and subcortical low densities crossing typical vascular territories).
Key inclusion criteria (2 listed)
- Clinical diagnosis of acute ischemic stroke
- Admission within 12 hours
Key exclusion criteria (6 listed)
- Lacunar infarction
- Cerebral hemorrhagic infarction
- Epilepsy or epileptic persons
- History of neurological diseases, myocardial infarction, renal and hepatic abnormalities and metabolic diseases
- Contraindications to antiplatelet treatments
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
Modified Rankin Scale scores
Time frame: 3 months
0 = No symptoms; 1 = No significant disability. Able to carry out all usual activities, despite some symptoms; 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3 = Moderate disability. Requires some help, but able to walk unassisted; 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6 = Dead.
1 secondary outcome
Glasgow Outcome Scale scores
Time frame: 3 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 11 Aug 2020.
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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.
Lixia Xue, M.D., Ph.D. study director
Shanghai 6th People's Hospital
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 Acute Ischemic Stroke, run by Shanghai 6th People's Hospital at 1 site in China.
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 6 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 Aug 2020. 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 China. 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?
Modified Rankin Scale scores (time frame: 3 months). 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 Aug 2020.