Copeptin for Risk Stratification in Non-traumatic Headache in the Emergency Setting - The CoHead Study
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Copeptin for Risk Stratification in Non-traumatic Headache in the Emergency Setting - The CoHead Study|
- 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. ] [ Designated as safety issue: No ]
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.
- clinical outcome of patients [ Time Frame: study entry and 3-month-interview ] [ Designated as safety issue: No ]
- 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
- Additive benefit on sensitivity if copeptin and a diagnostic algorithm are combined [ Time Frame: study entry and 3-month-interview ] [ Designated as safety issue: No ]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.
- Comparison of copeptin with other potential biomarkers in non-traumatic headache [ Time Frame: study entry and 3-month-interview ] [ Designated as safety issue: No ]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
|Study Start Date:||October 2010|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174901
|Kantonsspital Aarau AG|
|Aarau, AG, Switzerland, 5001|
|University Hospital of Basel|
|Basel, BS, Switzerland, 4031|
|Principal Investigator:||Mirjam Christ-Crain, MD, PhD||Department of Endocrinology, University Hospital of Basel, Switzerland|