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Copeptin for Risk Stratification in Non-traumatic Headache in the Emergency Setting - The CoHead Study (CoHead)

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ClinicalTrials.gov Identifier: NCT01174901
Recruitment Status : Completed
First Posted : August 4, 2010
Last Update Posted : May 26, 2014
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:

Headache is a common symptom, and patients often seek medical attention at emergency departments due to headaches.

The aim of the CoHead Study is to find out if it is possible by measuring copeptin, a marker of stress in the blood, to find out which patients have simple headaches and which patients have dangerous headaches that are the symptom of an underlying disease and need further investigation and treatment.

Copeptin is a marker for physical stress and has been tested in patients with stroke, heart attack and pneumonia. In all these illnesses, the patients with the most serious forms had the highest levels of copeptin, while the ones with only mild presentation or no affection at all had the lowest levels of copeptin.

The investigators expect to show the same in patients with headaches.

Condition or disease
Head Pain

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Copeptin for Risk Stratification in Non-traumatic Headache in the Emergency Setting - The CoHead Study
Study Start Date : October 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Differentiation between serious secondary non-traumatic headache as opposed to benign, self-limiting non-traumatic headache by copeptin level measurement [ Time Frame: At study entry, assessment of baseline characteristics, questionnaire, further investigations done by attending physician, and blood collection for copeptin measurement. telephone interview after 3 months. ]

    Assessment of the prognostic value of copeptin to predict the primary endpoint (serious secondary NTH).

    Non-traumatic headache (NTH) will be assessed and defined according to the ICHD-II-Criteria. Serious secondary NTH will be defined as a composite endpoint including different secondary NTH causes and entities as listed in the ICHD-II-Criteria.

Secondary Outcome Measures :
  1. clinical outcome of patients [ Time Frame: study entry and 3-month-interview ]
    • all-cause mortality within the 3-month follow-up period
    • morbidity measured by the MIDAS-questionnaire which is performed at study entry and at the 3-month-interview

  2. Additive benefit on sensitivity if copeptin and a diagnostic algorithm are combined [ Time Frame: study entry and 3-month-interview ]
    A validated, diagnostic algorithm consisting of four clinical scenarios (published by Grimaldi et al.) will be used by the study team upon entry into the study. We will evaluate the additive benefit of copeptin to this algorithm with means of multivariate logistic regression analysis and calculation of reclassification tables.

  3. Comparison of copeptin with other potential biomarkers in non-traumatic headache [ Time Frame: study entry and 3-month-interview ]
    We will compare the diagnostic and prognostic accuracy of copeptin with other potential biomarkers which have been reported to be of diagnostic value in migraine or cerebrovascular events, both being potential clinical scenarios of non-traumatic headache.

Biospecimen Retention:   Samples Without DNA
7.5 ml of EDTA blood, 7.5 ml of serum, 4.3 ml of citrate blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients presenting to emergency department or walk-in clinic

Inclusion Criteria:

  • headache at the time of screening
  • Patients must be able to give informed consent

Exclusion Criteria:

  • less than 18 years of age
  • preceding (head) trauma

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): NCT01174901

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Kantonsspital Aarau AG
Aarau, AG, Switzerland, 5001
University Hospital of Basel
Basel, BS, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
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Principal Investigator: Mirjam Christ-Crain, MD, PhD Department of Endocrinology, University Hospital of Basel, Switzerland
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01174901    
Other Study ID Numbers: CoHead
First Posted: August 4, 2010    Key Record Dates
Last Update Posted: May 26, 2014
Last Verified: May 2014
Keywords provided by University Hospital, Basel, Switzerland:
C-terminal provasopression
physiological stress response
Additional relevant MeSH terms:
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Diabetes Insipidus
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases