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

August 12, 2018 updated by: Bnai Zion Medical Center
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
24 months
C-reactive protein levels
Time Frame: 24 months
single blood sample will be drawn to measure c-reactive protein levels (mcg/dl).
24 months
Hair Cortisol level
Time Frame: 24 months
single hair sample will be drawn to measure cortisol levels (mcg/dl)
24 months
INL-6
Time Frame: 24 months
single blood sample will be drawn to measure INL-6 levels.
24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bnai Zion Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimate)

October 27, 2015

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 12, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0065-15-BNZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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