Copeptin for Risk Stratification in Acute Stroke Patients: the CoRisk Study

NCT00878813 | Completed

• 1 other identifier: KEK 001/09
• Study Type: observational
• Target: 1,102
• Locations: 2 countries
• Sites: 4

Brief Summary

Prospective observational multicenter study to evaluate copeptin as a prognostic marker in patients with an acute cerebrovascular event. It includes four groups of patients, mainly depending on type of initial therapy (intra-arterial thrombolysis, intravenous thrombolysis, conservative treatment, TIA). The study takes place at the Emergency and neurological Department of the University of Bern, Switzerland; Department of Neurology, Goethe University of Frankfurt a.M. (Germany). Further participating centers are under discussion

Conditions

Stroke; Transient Ischemic Attack

Keywords

Copeptin; Vasopressin; Stroke; Transient ischemic attack; Thrombolytic therapy; Prognosis; Complications

Outcome Measures

Primary Outcomes (1)

• Major disability or death

  90 days after qualifying event

Secondary Outcomes (6)

• Symptomatic intracranial hemorrhage

  until hospital discharge

• Malignant brain oedema

  until hospital discharge

• Aspiration pneumonia

  until hospital discharge

• Seizure

  until hospital discharge

• Mortality

  until hospital discharge

Study Arms (4)

1

All consecutive stroke patients undergoing acute intra-arterial revascularisation therapy

Procedure: Sampling of 15ml blood; Procedure: Blood-Sampling

2

All consecutive stroke patients undergoing acute intra-venous revascularisation therapy

Procedure: Sampling of 15ml blood; Procedure: Blood-Sampling

3

All consecutive stroke patients treated conservatively

Procedure: Sampling of 15ml blood

4

All consecutive TIA patients

Procedure: Sampling of 15ml blood

Interventions

Sampling of 15ml blood PROCEDURE

On admission, 2 x 7.5ml blood tubes will be drawn during the first routine blood sampling

1; 2; 3; 4

Blood-Sampling PROCEDURE

On day 1 after intra-arterial thrombolysis, 2 x 7.5ml blood tubes on the following routine blood-sampling will be drawn.

1; 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive patients who are admitted to the emergency department of the Inselspital Bern - Switzerland with a clinical diagnosis of acute ischemic stroke within 24 hours of symptom onset. Inselspital Bern is a university based hospital with a catchment area of about 1.000.000 people

You may qualify if:

• All consecutive patients who are admitted to the emergency department with a clinical diagnosis of cerebrovascular event (TIA, stroke) within 24 hours of symptom onset

You may not qualify if:

• Patients without informed consent. Patients discharged with a diagnosis different from stroke or TIA after diagnostic evaluation.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Basel: collaborator
• Charite University, Berlin, Germany: collaborator
• Goethe University: collaborator

Study Sites (4)

Abteilung für Neurologie Charité - Campus Benjamin Franklin

Berlin, Germany

Location

Goethe University

Frankfurt am Main, Germany

Location

Neurologische Klinik, Universitätsspital Basel

Basel, 4031, Switzerland

Location

University Clinic for Neurology, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (15)

• Furlan A, Higashida R, Wechsler L, Gent M, Rowley H, Kase C, Pessin M, Ahuja A, Callahan F, Clark WM, Silver F, Rivera F. Intra-arterial prourokinase for acute ischemic stroke. The PROACT II study: a randomized controlled trial. Prolyse in Acute Cerebral Thromboembolism. JAMA. 1999 Dec 1;282(21):2003-11. doi: 10.1001/jama.282.21.2003.

  PMID: 10591382 BACKGROUND

• Mattle HP, Arnold M, Georgiadis D, Baumann C, Nedeltchev K, Benninger D, Remonda L, von Budingen C, Diana A, Pangalu A, Schroth G, Baumgartner RW. Comparison of intraarterial and intravenous thrombolysis for ischemic stroke with hyperdense middle cerebral artery sign. Stroke. 2008 Feb;39(2):379-83. doi: 10.1161/STROKEAHA.107.492348. Epub 2007 Dec 20.

  PMID: 18096842 BACKGROUND

• Maramattom BV, Bahn MM, Wijdicks EF. Which patient fares worse after early deterioration due to swelling from hemispheric stroke? Neurology. 2004 Dec 14;63(11):2142-5. doi: 10.1212/01.wnl.0000145626.30318.8a.

  PMID: 15596765 BACKGROUND

• Aslanyan S, Weir CJ, Diener HC, Kaste M, Lees KR; GAIN International Steering Committee and Investigators. Pneumonia and urinary tract infection after acute ischaemic stroke: a tertiary analysis of the GAIN International trial. Eur J Neurol. 2004 Jan;11(1):49-53. doi: 10.1046/j.1468-1331.2003.00749.x.

  PMID: 14692888 BACKGROUND

• Warach S, Latour LL. Evidence of reperfusion injury, exacerbated by thrombolytic therapy, in human focal brain ischemia using a novel imaging marker of early blood-brain barrier disruption. Stroke. 2004 Nov;35(11 Suppl 1):2659-61. doi: 10.1161/01.STR.0000144051.32131.09. Epub 2004 Oct 7.

  PMID: 15472105 BACKGROUND

• Rubiera M, Alvarez-Sabin J, Ribo M, Montaner J, Santamarina E, Arenillas JF, Huertas R, Delgado P, Purroy F, Molina CA. Predictors of early arterial reocclusion after tissue plasminogen activator-induced recanalization in acute ischemic stroke. Stroke. 2005 Jul;36(7):1452-6. doi: 10.1161/01.STR.0000170711.43405.81. Epub 2005 Jun 9.

  PMID: 15947260 BACKGROUND

• Adams HP Jr, del Zoppo G, Alberts MJ, Bhatt DL, Brass L, Furlan A, Grubb RL, Higashida RT, Jauch EC, Kidwell C, Lyden PD, Morgenstern LB, Qureshi AI, Rosenwasser RH, Scott PA, Wijdicks EF; American Heart Association; American Stroke Association Stroke Council; Clinical Cardiology Council; Cardiovascular Radiology and Intervention Council; Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups. Guidelines for the early management of adults with ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: the American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Stroke. 2007 May;38(5):1655-711. doi: 10.1161/STROKEAHA.107.181486. Epub 2007 Apr 12.

  PMID: 17431204 BACKGROUND

• Toni D, Chamorro A, Kaste M, Lees K, Wahlgren NG, Hacke W; EUSI Executive Committee; EUSI Writing Committee. Acute treatment of ischaemic stroke. European Stroke Initiative. Cerebrovasc Dis. 2004;17 Suppl 2:30-46. doi: 10.1159/000074818. No abstract available.

  PMID: 14707405 BACKGROUND

• Morgenthaler NG, Struck J, Alonso C, Bergmann A. Assay for the measurement of copeptin, a stable peptide derived from the precursor of vasopressin. Clin Chem. 2006 Jan;52(1):112-9. doi: 10.1373/clinchem.2005.060038. Epub 2005 Nov 3.

  PMID: 16269513 BACKGROUND

• Katan M, Morgenthaler N, Widmer I, Puder JJ, Konig C, Muller B, Christ-Crain M. Copeptin, a stable peptide derived from the vasopressin precursor, correlates with the individual stress level. Neuro Endocrinol Lett. 2008 Jun;29(3):341-6.

  PMID: 18580851 BACKGROUND

• Rudin S, Kriemler L, Dittrich TD, Zietz A, Schweizer J, Arnold M, Peters N, Barinka F, Jung S, Arnold M, Fischer U, Rentsch K, Christ-Crain M, Katan M, De Marchis GM. Lipoprotein(a) as a blood marker for large artery atherosclerosis stroke etiology: validation in a prospective cohort from a swiss stroke center. Swiss Med Wkly. 2024 Apr 2;154:3633. doi: 10.57187/s.3633.

  PMID: 38579294 DERIVED

• De Marchis GM, Dankowski T, Konig IR, Fladt J, Fluri F, Gensicke H, Foerch C, Findling O, Kurmann R, Fischer U, Luft A, Buhl D, Engelter ST, Lyrer PA, Christ-Crain M, Arnold M, Katan M. A novel biomarker-based prognostic score in acute ischemic stroke: The CoRisk score. Neurology. 2019 Mar 26;92(13):e1517-e1525. doi: 10.1212/WNL.0000000000007177. Epub 2019 Mar 1.

  PMID: 30824558 DERIVED

• De Marchis GM, Weck A, Audebert H, Benik S, Foerch C, Buhl D, Schuetz P, Jung S, Seiler M, Morgenthaler NG, Mattle HP, Mueller B, Christ-Crain M, Arnold M, Katan M. Copeptin for the prediction of recurrent cerebrovascular events after transient ischemic attack: results from the CoRisk study. Stroke. 2014 Oct;45(10):2918-23. doi: 10.1161/STROKEAHA.114.005584. Epub 2014 Aug 28.

  PMID: 25169950 DERIVED

• De Marchis GM, Katan M, Weck A, Brekenfeld C, Mattle HP, Buhl D, Muller B, Christ-Crain M, Arnold M. Copeptin and risk stratification in patients with ischemic stroke and transient ischemic attack: the CoRisk study. Int J Stroke. 2013 Apr;8(3):214-8. doi: 10.1111/j.1747-4949.2011.00762.x. Epub 2012 Feb 15.

  PMID: 22336226 DERIVED

• Katan M, Elkind MS. Inflammatory and neuroendocrine biomarkers of prognosis after ischemic stroke. Expert Rev Neurother. 2011 Feb;11(2):225-39. doi: 10.1586/ern.10.200.

  PMID: 21306210 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

In all patients: 5 ml serum In patients undergoing intra-arterial revascularisation: 10 ml serum

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient; Diabetes Insipidus

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Gian Marco De Marchis, MD

  Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

• Marcel Arnold, MD

  Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

• Mira Katan, MD

  University Hospital, 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: April 1, 2009
• First Posted: April 9, 2009
• Study Start: March 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 10, 2011

Record last verified: 2011-11

Locations

CH (2); DE (2)