NCT02587949

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 26, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

4 years

First QC Date

October 26, 2015

Last Update Submit

August 12, 2018

Conditions

Cerebrovascular Stroke

Keywords

acute cerebrovascular stroke

Outcome Measures

Primary Outcomes (4)

  • Anti Tumor Necrosis Factor alpha

    single blood sample will be drawn to measure Anti Tumor Necrosis Factor alpha levels (pg/ml).

    24 months

  • C-reactive protein levels

    single blood sample will be drawn to measure c-reactive protein levels (mcg/dl).

    24 months

  • Hair Cortisol level

    single hair sample will be drawn to measure cortisol levels (mcg/dl)

    24 months

  • INL-6

    single blood sample will be drawn to measure INL-6 levels.

    24 months

Secondary Outcomes (4)

  • TSH

    24 months

  • FT4

    24 months

  • FT3

    24 months

  • Cortisol

    24 months

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Patients aged 40-80.
  • Acute cerebrovascular stroke (symptoms that began no more than 72 hours before)
  • Rankin 0-1 before the event

You may not qualify if:

  • Suspicion or known Cushing's syndrome
  • Known adrenal failure
  • Chronic inflammatory disease
  • Active malignancy
  • Acute infectious disease within 4 months before enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mira Koch

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Mira Koch

CONTACT

97248359351mira.koch@b-zion.org.il

Michal Yeiches

CONTACT

97248359484yeiches@gmail.com

Study Design

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

Study Record Dates

First Submitted

October 26, 2015

First Posted

October 27, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

August 14, 2018

Record last verified: 2018-08

Locations

IL(1)