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Hair Cortisol and the Risk of Stroke

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ClinicalTrials.gov Identifier: NCT02090270
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

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.

Condition or disease
ISCHEMIC STROKE

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
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hair Cortisol and the Risk of Stroke
Study Start Date : March 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016


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.



Primary Outcome Measures :
  1. Concentration of hair cortisol [ Time Frame: Hospital stay, on average - 24 hours from admission to hospital ]

Biospecimen Retention:   Samples Without DNA
Hair


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090270


Locations
Israel
Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Eilon Krashin, MD Meir Medical Center

Publications:
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT02090270     History of Changes
Other Study ID Numbers: MMC-13-0275-CTIL
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: January 2015

Keywords provided by Meir Medical Center:
hair cortisol
stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents