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

This study has been completed.
Sponsor:
Collaborators:
University of Basel
Charite University, Berlin, Germany
Goethe University
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00878813
First received: April 1, 2009
Last updated: November 9, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention
Stroke
Transient Ischemic Attack
Procedure: Sampling of 15ml blood
Procedure: Blood-Sampling

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Copeptin for Risk Stratification in Acute Stroke Patients: the CoRisk-study

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Major disability or death [ Time Frame: 90 days after qualifying event ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptomatic intracranial hemorrhage [ Time Frame: until hospital discharge ] [ Designated as safety issue: No ]
  • Malignant brain oedema [ Time Frame: until hospital discharge ] [ Designated as safety issue: No ]
  • Aspiration pneumonia [ Time Frame: until hospital discharge ] [ Designated as safety issue: No ]
  • Seizure [ Time Frame: until hospital discharge ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: until hospital discharge ] [ Designated as safety issue: No ]
  • severe cerebrovascular re-event (i.e. new TIA, and stroke) [ Time Frame: 90 days after qualifying event ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

In all patients: 5 ml serum

In patients undergoing intra-arterial revascularisation: 10 ml serum


Enrollment: 1102
Study Start Date: March 2009
Study Completion Date: October 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
All consecutive stroke patients undergoing acute intra-arterial revascularisation therapy
Procedure: Sampling of 15ml blood
On admission, 2 x 7.5ml blood tubes will be drawn during the first routine blood sampling
Procedure: Blood-Sampling
On day 1 after intra-arterial thrombolysis, 2 x 7.5ml blood tubes on the following routine blood-sampling will be drawn.
2
All consecutive stroke patients undergoing acute intra-venous revascularisation therapy
Procedure: Sampling of 15ml blood
On admission, 2 x 7.5ml blood tubes will be drawn during the first routine blood sampling
Procedure: Blood-Sampling
On day 1 after intra-arterial thrombolysis, 2 x 7.5ml blood tubes on the following routine blood-sampling will be drawn.
3
All consecutive stroke patients treated conservatively
Procedure: Sampling of 15ml blood
On admission, 2 x 7.5ml blood tubes will be drawn during the first routine blood sampling
4
All consecutive TIA patients
Procedure: Sampling of 15ml blood
On admission, 2 x 7.5ml blood tubes will be drawn during the first routine blood sampling

Detailed Description:

Background

The investigators in the Prolyse in Acute Cerebral Thromboembolism (PROACT) II study found that intra-arterial thrombolysis (IAT) with prourokinase within 6 hours after onset of symptoms was beneficial in patients with middle cerebral artery (MCA) occlusion. Intra-arterial thrombolysis (IAT) thus is an option for treatment of selected patients who have major stroke of <6 hours' duration due to occlusions of the MCA. Recently observational study showed that IAT was more beneficial than intra-venous thrombolysis (IVT) in the specific group of stroke patients presenting with hyperdense middle cerebral artery sign on CT, even though IAT was started later.

However complications after both reperfusion treatment modalities such as symptomatic intracerebral hemorrhage, malignant brain oedema, re-occlusion, infection, and seizures may occur. Unfortunately few clinical signs provide prognostic information for clear risk stratification. The guidelines for reperfusion therapies in Switzerland, Europe and the US do not include -for the time being- biomarkers in the decision-making-process. However there might be powerful biomarkers, which can serve as point of care tools for the risk stratification of candidates to receive thrombolysis. Plasma copeptin concentration has recently been shown to be an easy to determine, steady parameter which independently predicts functional outcome and death in patients with an acute ischemic stroke. Copeptin derives from a larger precursor peptide (pre-provasopressin) along with two other peptides, Vasopressin (AVP) and neurophysin II. Released in an equimolar ratio, the amount of copeptin mirrors the production of AVP. AVP plays an important role in the regulation of the hypothalamo-pituitary-adrenal (HPA) axis and, thus, reflecting the individual stress response. "Stressors" such as stroke are strong stimulators of the release of AVP. The close and reproducible relation of copeptin levels to the degree of activation of the stress axis is the basis of its usefulness as a biomarker. Early prognostic factors to predict mortality and outcome in stroke patients are important to guide and tailor early decision on treatment. In this context, copeptin may be helpful tool in the early risk stratification of stroke patients to guide the decision for reperfusion therapies.

Objective

To evaluate copeptin as prognostic tool to predict outcome in a well-defined cohort of stroke patients.

Methods

Step 1. All eligible patients in the emergency department or the neurological ward will be evaluated for enrollment into the study. On admission, 2 x 7.5ml- EDTA-blood tubes will be drawn during the first routine blood sampling, and 2 x 7.5ml-EDTA-blood tubes on the following routine blood-sampling. Copeptin levels will be assessed in a blinded batch analysis upon completion of the plasma asservation. Measurement will be performed with a new chemiluminescence sandwich immunoassay.

Step 2. All baseline data will be collected. CT or MRI will be performed 22 to 36 hours after IAT. All complications including death after the reperfusion therapies will be assessed until discharge.

Step 3. A telephone follow-up regarding morbidity and mortality will be obtained after 3 months. An unfavorable outcome will be defined as a mRs of 3 to 6

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878813

Locations
Germany
Abteilung für Neurologie Charité - Campus Benjamin Franklin
Berlin, Germany
Goethe University
Frankfurt am Main, Germany
Switzerland
Neurologische Klinik, Universitätsspital Basel
Basel, Switzerland, 4031
University Clinic for Neurology, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Basel
Charite University, Berlin, Germany
Goethe University
Investigators
Principal Investigator: 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
  More Information

Publications:
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. Epub 2007 Apr 12. Erratum in: Stroke. 2007 Jun;38(6):e38. Stroke. 2007 Sep;38(9):e96.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00878813     History of Changes
Other Study ID Numbers: KEK 001/09
Study First Received: April 1, 2009
Last Updated: November 9, 2011
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
Copeptin
Vasopressin
Stroke
Transient ischemic attack
Thrombolytic therapy
Prognosis
Complications

Additional relevant MeSH terms:
Ischemic Attack, Transient
Ischemia
Stroke
Cerebral Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction

ClinicalTrials.gov processed this record on August 28, 2014