Cerebrovascular StrokeNCT02587949
The Correlation Between Hair Cortisol Level of Acute Stroke or Its Long Term Disability.
An observational study of Cerebrovascular Stroke, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
In patients admitted to hospital with acute cerebrovascular stroke, we want to study the relationship between hair cortisol levels and biomarkers of inflammation and the clinical and radiological severity of the stroke and the degree of neurological disability being tested in three months and one year after. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cerebrovascular Stroke
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2015to Nov 2019
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Patients aged 40-80. 2. Acute cerebrovascular stroke (symptoms that began no more than 72 hours before) 3. Rankin 0-1 before the event
Who may be able to join
- Patients aged 40-80.
- Acute cerebrovascular stroke (symptoms that began no more than 72 hours before)
- Rankin 0-1 before the event
Who cannot join
- Suspicion or known Cushing's syndrome
- Known adrenal failure
- Chronic inflammatory disease
- Active malignancy
- Acute infectious disease within 4 months before enrollment
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Mira Koch
Haifa
Mira Koch, 97248359531, mira.koch@b-zion.org.il
Michal Yeiches, 97248359484 ext. Yeiches, yeiches@gmail.com
About this study
In patients admitted to hospital with acute cerebrovascular stroke, we want to study the relationship between hair cortisol levels and biomarkers of inflammation and the clinical and radiological severity of the stroke and the degree of neurological disability being tested in three months and one year after.
Read the detailed description
The study will include patients hospitalized due to an acute cerebrovascular stroke. A number of 30 patients aged 40-70 will be included. Within 48 hours of the event, blood inflammatory biomarkers, and scalp hair sample for cortisol will be taken. All recruited patients will undergo full neurological examination and the severity of the stroke will be rated using NIHSS (National Institutes of Health Stroke Scale). 3 months and one year later neurological examination and rating of neurological disability will be determined using Rankin Scale.
- Conditions
- Cerebrovascular Stroke
- Keywords
- acute cerebrovascular stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti Tumor Necrosis Factor alpha
single blood sample will be drawn to measure Anti Tumor Necrosis Factor alpha levels (pg/ml).
Measured: 24 months
C-reactive protein levels
single blood sample will be drawn to measure c-reactive protein levels (mcg/dl).
Measured: 24 months
Hair Cortisol level
single hair sample will be drawn to measure cortisol levels (mcg/dl)
Measured: 24 months
INL-6
single blood sample will be drawn to measure INL-6 levels.
Measured: 24 months
Secondary outcomes (4)
TSH
single blood sample will be drawn to measure Thyroid-Stimulating Hormone (mcIU/ml).
Measured: 24 months
FT4
single blood sample will be drawn to measure Free Thyroxine (pmol/L) .
Measured: 24 months
FT3
single blood sample will be drawn to measure Free Triiodothyronine (pmol/L).
Measured: 24 months
Cortisol
single blood sample will be drawn to measure cortisol levels (mcg/dl).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587949
- Sponsor's protocol ID
- 0065-15-BNZ
- Status last verified
- Aug 2018
- First submitted
- 26 Oct 2015
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Hair Cortisol Level of Acute Stroke or Its Long Term Disability.
- ClinicalTrials.gov ID
- NCT02587949
- Acronym / sponsor ID
- 0065-15-BNZ
- Conditions
- Cerebrovascular Stroke
- Keywords
- acute cerebrovascular stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Nov 2015
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 27 Oct 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.
In patients admitted to hospital with acute cerebrovascular stroke, we want to study the relationship between hair cortisol levels and biomarkers of inflammation and the clinical and radiological severity of the stroke and the degree of neurological disability being tested in three months and one year after.
Detailed description
The study will include patients hospitalized due to an acute cerebrovascular stroke. A number of 30 patients aged 40-70 will be included. Within 48 hours of the event, blood inflammatory biomarkers, and scalp hair sample for cortisol will be taken. All recruited patients will undergo full neurological examination and the severity of the stroke will be rated using NIHSS (National Institutes of Health Stroke Scale). 3 months and one year later neurological examination and rating of neurological disability will be determined using Rankin Scale.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients aged 40-80. 2. Acute cerebrovascular stroke (symptoms that began no more than 72 hours before) 3. Rankin 0-1 before the event
Key inclusion criteria (3 listed)
- Patients aged 40-80.
- Acute cerebrovascular stroke (symptoms that began no more than 72 hours before)
- Rankin 0-1 before the event
Key exclusion criteria (5 listed)
- Suspicion or known Cushing's syndrome
- Known adrenal failure
- Chronic inflammatory disease
- Active malignancy
- Acute infectious disease within 4 months before enrollment
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
Anti Tumor Necrosis Factor alpha
Time frame: 24 months
single blood sample will be drawn to measure Anti Tumor Necrosis Factor alpha levels (pg/ml).
C-reactive protein levels
Time frame: 24 months
single blood sample will be drawn to measure c-reactive protein levels (mcg/dl).
Hair Cortisol level
Time frame: 24 months
single hair sample will be drawn to measure cortisol levels (mcg/dl)
INL-6
Time frame: 24 months
single blood sample will be drawn to measure INL-6 levels.
4 secondary outcomes
TSH
Time frame: 24 months
FT4
Time frame: 24 months
FT3
Time frame: 24 months
Cortisol
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
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 Cerebrovascular Stroke, run by Bnai Zion Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 14 Aug 2018. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mira Koch (97248359351, mira.koch@b-zion.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti Tumor Necrosis Factor alpha (time frame: 24 months). The study lists 4 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 14 Aug 2018.