The Correlation Between Hair Cortisol Level of Acute Stroke or Its Long Term Disability.

Sponsor

Bnai Zion Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02587949

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Stroke

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

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

The Correlation Between Hair Cortisol Level of Acute Stroke or Its Long Term Disability.

Study Start Date :

Nov 1, 2015

Anticipated Primary Completion Date :

Nov 1, 2019

Anticipated Study Completion Date :

Nov 1, 2019

Outcome Measures

Primary Outcome Measures

Anti Tumor Necrosis Factor alpha [24 months]
single blood sample will be drawn to measure Anti Tumor Necrosis Factor alpha levels (pg/ml).
C-reactive protein levels [24 months]
single blood sample will be drawn to measure c-reactive protein levels (mcg/dl).
Hair Cortisol level [24 months]
single hair sample will be drawn to measure cortisol levels (mcg/dl)
INL-6 [24 months]
single blood sample will be drawn to measure INL-6 levels.

Secondary Outcome Measures

TSH [24 months]
single blood sample will be drawn to measure Thyroid-Stimulating Hormone (mcIU/ml).
FT4 [24 months]
single blood sample will be drawn to measure Free Thyroxine (pmol/L) .
FT3 [24 months]
single blood sample will be drawn to measure Free Triiodothyronine (pmol/L).
Cortisol [24 months]
single blood sample will be drawn to measure cortisol levels (mcg/dl).

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients aged 40-80.
Acute cerebrovascular stroke (symptoms that began no more than 72 hours before)
Rankin 0-1 before the event

Exclusion criteria:

Suspicion or known Cushing's syndrome
Known adrenal failure
Chronic inflammatory disease
Active malignancy
Acute infectious disease within 4 months before enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mira Koch	Haifa		Israel

Sponsors and Collaborators

Bnai Zion Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bnai Zion Medical Center

ClinicalTrials.gov Identifier:

NCT02587949

Other Study ID Numbers:

0065-15-BNZ

First Posted:

Oct 27, 2015

Last Update Posted:

Aug 14, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Bnai Zion Medical Center

acute cerebrovascular stroke

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Aug 14, 2018