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

Cerebrovascular Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02587949
• Other study ID #: 0065-15-BNZ
• Status: Recruiting
• Start date: November 2015
• Est. completion date: November 2019

Study information

• Verified date: August 2018
• Source: Bnai Zion Medical Center
• Contact: Mira Koch
• Phone: 97248359351
• Email: mira.koch[@]b-zion.org.il
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Stroke
• Stroke

Locations

Country	Name	City	State
Israel	Mira Koch	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti Tumor Necrosis Factor alpha	single blood sample will be drawn to measure Anti Tumor Necrosis Factor alpha levels (pg/ml).	24 months
Primary	C-reactive protein levels	single blood sample will be drawn to measure c-reactive protein levels (mcg/dl).	24 months
Primary	Hair Cortisol level	single hair sample will be drawn to measure cortisol levels (mcg/dl)	24 months
Primary	INL-6	single blood sample will be drawn to measure INL-6 levels.	24 months
Secondary	TSH	single blood sample will be drawn to measure Thyroid-Stimulating Hormone (mcIU/ml).	24 months
Secondary	FT4	single blood sample will be drawn to measure Free Thyroxine (pmol/L) .	24 months
Secondary	FT3	single blood sample will be drawn to measure Free Triiodothyronine (pmol/L).	24 months
Secondary	Cortisol	single blood sample will be drawn to measure cortisol levels (mcg/dl).	24 months