Hair Cortisol and the Risk of Stroke

NCT ID: NCT02090270

Last Updated: 2016-03-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-03-31

Brief Summary

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.

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.

Conditions

ISCHEMIC STROKE

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Control

Patients admitted to an internal medicine department for indications other than stroke or acute myocardial ischemia.

No interventions assigned to this group

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eilon Krashin, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

Meir Medical Center

Kfar Saba, , Israel

Countries

Israel

References

Stalder T, Kirschbaum C. Analysis of cortisol in hair--state of the art and future directions. Brain Behav Immun. 2012 Oct;26(7):1019-29. doi: 10.1016/j.bbi.2012.02.002. Epub 2012 Feb 15.

Reference Type: BACKGROUND

PMID: 22366690 (View on PubMed)

Other Identifiers

MMC-13-0275-CTIL

Identifier Type: -

Identifier Source: org_study_id