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

NCT01174901 | Completed

• 1 other identifier: CoHead
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

Head Pain

Keywords

cephalalgia; copeptins; biomarkers; headache; C-terminal provasopression; physiological stress response

Outcome Measures

Primary Outcomes (1)

• Differentiation between serious secondary non-traumatic headache as opposed to benign, self-limiting non-traumatic headache by copeptin level measurement

  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.

  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.

Secondary Outcomes (3)

• clinical outcome of patients

  study entry and 3-month-interview

• Additive benefit on sensitivity if copeptin and a diagnostic algorithm are combined

  study entry and 3-month-interview

• Comparison of copeptin with other potential biomarkers in non-traumatic headache

  study entry and 3-month-interview

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting to emergency department or walk-in clinic

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (2)

Kantonsspital Aarau AG

Aarau, Canton of Aargau, 5001, Switzerland

Location

University Hospital of Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (6)

• Katan M, Fluri F, Morgenthaler NG, Schuetz P, Zweifel C, Bingisser R, Muller K, Meckel S, Gass A, Kappos L, Steck AJ, Engelter ST, Muller B, Christ-Crain M. Copeptin: a novel, independent prognostic marker in patients with ischemic stroke. Ann Neurol. 2009 Dec;66(6):799-808. doi: 10.1002/ana.21783.

  PMID: 20035506 BACKGROUND

• Katan M, Muller B, Christ-Crain M. Copeptin: a new and promising diagnostic and prognostic marker. Crit Care. 2008;12(2):117. doi: 10.1186/cc6799. Epub 2008 Mar 6.

  PMID: 18355399 BACKGROUND

• Reichlin T, Hochholzer W, Stelzig C, Laule K, Freidank H, Morgenthaler NG, Bergmann A, Potocki M, Noveanu M, Breidthardt T, Christ A, Boldanova T, Merki R, Schaub N, Bingisser R, Christ M, Mueller C. Incremental value of copeptin for rapid rule out of acute myocardial infarction. J Am Coll Cardiol. 2009 Jun 30;54(1):60-8. doi: 10.1016/j.jacc.2009.01.076.

  PMID: 19555842 BACKGROUND

• Friedman BW, Hochberg ML, Esses D, Grosberg B, Corbo J, Toosi B, Meyer RH, Bijur PE, Lipton RB, Gallagher EJ. Applying the International Classification of Headache Disorders to the emergency department: an assessment of reproducibility and the frequency with which a unique diagnosis can be assigned to every acute headache presentation. Ann Emerg Med. 2007 Apr;49(4):409-19, 419.e1-9. doi: 10.1016/j.annemergmed.2006.11.004. Epub 2007 Jan 8.

  PMID: 17210203 BACKGROUND

• Grimaldi D, Cevoli S, Cortelli P. Headache in the emergency department. How to handle the problem? Neurol Sci. 2008 May;29 Suppl 1:S103-6. doi: 10.1007/s10072-008-0899-0.

  PMID: 18545909 BACKGROUND

• Blum CA, Winzeler B, Nigro N, Schuetz P, Biethahn S, Kahles T, Mueller C, Timper K, Haaf K, Tepperberg J, Amort M, Huber A, Bingisser R, Sandor PS, Nedeltchev K, Muller B, Katan M, Christ-Crain M. Copeptin for risk stratification in non-traumatic headache in the emergency setting: a prospective multicenter observational cohort study. J Headache Pain. 2017 Dec;18(1):21. doi: 10.1186/s10194-017-0733-2. Epub 2017 Feb 13.

  PMID: 28197843 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

7.5 ml of EDTA blood, 7.5 ml of serum, 4.3 ml of citrate blood

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mirjam Christ-Crain, MD, PhD

  Department of Endocrinology, University Hospital of Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 2, 2010
• First Posted: August 4, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: May 26, 2014

Record last verified: 2014-05

Locations

CH (2)