NCT02090270

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 23, 2016

Status Verified

January 1, 2015

Enrollment Period

2 years

First QC Date

March 12, 2014

Last Update Submit

March 22, 2016

Conditions

Keywords

hair cortisolstroke

Outcome Measures

Primary Outcomes (1)

  • Concentration of hair cortisol

    Hospital stay, on average - 24 hours from admission to hospital

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Male patients
  • Age of 18 years or older.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

Related Publications (1)

  • 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.

    PMID: 22366690BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Hair

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Eilon Krashin, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2014

First Posted

March 18, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 23, 2016

Record last verified: 2015-01

Locations