Hair Cortisol and the Risk of Stroke

March 22, 2016 updated by: Meir Medical Center
The purpose of this study is to prospectively examine the relation between ischemic stroke and hair cortisol concentration. The investigators hypothesize that patients with ischemic stroke have higher levels of hair cortisol compared to controls.

Study Overview

Status

Completed

Conditions

Detailed Description

Acute physical and emotional stressors are well known triggers of cardiovascular events. However, it is not clear whether the same association exists with chronic stress. Data on this issue have been limited by lack of adequate clinical studies and inconclusive results. One of the possible explanations may be the absence of a reliable mode for quantitative assessment of chronic stress. To date, studies on the effects of chronic stress on cardiovascular events have used psychosocial questionnaires. These are subject to recall bias, as having an event may stimulate the patient to strive harder to identify previous stressors. Furthermore, most studies on the association of chronic stress and cardiovascular events have focused on acute coronary events, and only few have examined the association with stroke.

Both physical and emotional stress activate several neuroendocrine systems, the most important being the hypothalamic-pituitary-adrenal (HPA) axis that stimulates the production and secretion of glucocorticoids (especially cortisol) from the adrenal cortex. Therefore, cortisol is considered to be a "stress hormone" and higher levels of serum cortisol have been observed in patients with acute stress such as those presenting with acute myocardial infarction and stroke compared to healthy controls. Moreover, it has been shown that serum cortisol levels correlates with the severity of the disease and adverse outcome in patients presenting with stroke.

Cortisol levels are routinely determined from blood, salivary or urinary samples. However, these methods do not provide information on long term cortisol secretion, accounting for the variability of HPA axis activity. There is a growing pool of evidence that shows that Hair Cortisol Concentration (HCC) examination provides a reliable retrospective estimation of integrated cortisol secretion over a period of several months. Hair grows at a rate of about 1 cm/month, thus 3 cm of hair would give an indication of the cortisol levels over the previous 3 months. HCC has been evaluated in several clinical settings in which activity of the HPA axis and cortisol levels over a period of time are of interest. Studies have demonstrated increased levels of hair cortisol in chronic stress, as well as conditions associated with stress such as pregnancy , unemployment , PTSD, alcohol withdrawal and chronic pain and more importantly, in patients admitted to hospital with acute myocardial infarction. Nevertheless, the association between hair cortisol levels and the risk for stroke has not yet been studied.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

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

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Meir Medical Center

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Cases - Consenting patients admitted to internal medicine wards with acute ischemic (non cardioembolic) stroke.

Controls - Consenting patients admitted to internal medicine wards due to indications other than stoke or acute myocardial infarction.

Description

Inclusion Criteria:

  • Male patients
  • Age of 18 years or older.

Exclusion Criteria:

  • Female sex.
  • Patients for whom a hair sample of at least 3cm from vertex posterior cannot be obtained.
  • Hemorrhagic stroke.
  • Documented atrial fibrillation or flutter during admission or at any time in the past.
  • Use of inhaled, systemic or topical corticosteroids at study initiation, or during the previous 12 months.
  • Disorders associated with disruption of HPA axis (Cushing syndrome, Addison syndrome).
  • Bleaching or use of artificial hair color.
  • Inability to sign informed consent.
  • Morbid obesity (BMI > 35).

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

Cohorts and Interventions

Group / Cohort
Ischemic stroke
Sudden onset of focal neurologic deficit lasting more than 24 hours, with cerebral hemorrhage ruled out by brain CT, in the absence of obvious causes of embolic stroke.
Control
Patients admitted to an internal medicine department for indications other than stroke or acute myocardial ischemia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentration of hair cortisol
Time Frame: Hospital stay, on average - 24 hours from admission to hospital
Hospital stay, on average - 24 hours from admission to hospital

Collaborators and Investigators

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

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: Eilon Krashin, MD, Meir Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2014

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

March 12, 2014

First Submitted That Met QC Criteria

March 16, 2014

First Posted (ESTIMATE)

March 18, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 23, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC-13-0275-CTIL

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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