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

• Conditions: Cerebrovascular Stroke

• Registration Number: NCT02587949
• Lead Sponsor: Bnai Zion Medical Center

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.

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 Timeline

• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-27
• Study Start: 2015-11
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-12
• Last Update Posted: 2018-08-14
• Primary Completion: 2019-11
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion criteria:

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Cortisol	24 months	single blood sample will be drawn to measure cortisol levels (mcg/dl).
FT3	24 months	single blood sample will be drawn to measure Free Triiodothyronine (pmol/L).
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) .

Trial Locations

Locations (1)

Mira Koch; 🇮🇱 Haifa, Israel