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

November 9, 2011 updated by: University Hospital Inselspital, Berne

Copeptin for Risk Stratification in Acute Stroke Patients: the CoRisk-study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

1102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Abteilung für Neurologie Charité - Campus Benjamin Franklin
      • Frankfurt am Main, Germany
        • Goethe University
  • Switzerland
      • Basel, Switzerland, 4031
        • Neurologische Klinik, Universitätsspital Basel
      • Bern, Switzerland, 3010
        • University Clinic for Neurology, Bern University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major disability or death
Time Frame: 90 days after qualifying event
90 days after qualifying event

Secondary Outcome Measures

Outcome Measure
Time Frame
Symptomatic intracranial hemorrhage
Time Frame: until hospital discharge
until hospital discharge
Malignant brain oedema
Time Frame: until hospital discharge
until hospital discharge
Aspiration pneumonia
Time Frame: until hospital discharge
until hospital discharge
Seizure
Time Frame: until hospital discharge
until hospital discharge
Mortality
Time Frame: until hospital discharge
until hospital discharge
severe cerebrovascular re-event (i.e. new TIA, and stroke)
Time Frame: 90 days after qualifying event
90 days after qualifying event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

Charite University, Berlin, Germany
Goethe University
University of Basel

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

April 1, 2009

First Submitted That Met QC Criteria

April 8, 2009

First Posted (Estimate)

April 9, 2009

Study Record Updates

Last Update Posted (Estimate)

November 10, 2011

Last Update Submitted That Met QC Criteria

November 9, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK 001/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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