Copeptin for Risk Stratification in Acute Stroke Patients: the CoRisk Study
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First Received Date ICMJE | April 1, 2009 | ||||||||||||
Last Updated Date | November 9, 2011 | ||||||||||||
Start Date ICMJE | March 2009 | ||||||||||||
Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
Major disability or death [ Time Frame: 90 days after qualifying event ] [ Designated as safety issue: No ] | ||||||||||||
Original Primary Outcome Measures ICMJE |
Major disability or death [ Time Frame: 90 days after qualifying stroke ] [ Designated as safety issue: No ] | ||||||||||||
Change History | Complete list of historical versions of study NCT00878813 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Original Other Outcome Measures ICMJE | |||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | Copeptin for Risk Stratification in Acute Stroke Patients: the CoRisk Study | ||||||||||||
Official Title ICMJE | Copeptin for Risk Stratification in Acute Stroke Patients: the CoRisk-study | ||||||||||||
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 |
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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 |
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Study Type ICMJE | Observational | ||||||||||||
Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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Biospecimen | Retention: Samples Without DNA Description: In all patients: 5 ml serum In patients undergoing intra-arterial revascularisation: 10 ml serum |
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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 |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||
Enrollment ICMJE | 1102 | ||||||||||||
Completion Date | October 2011 | ||||||||||||
Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | 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. |
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Gender | Both | ||||||||||||
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Accepts Healthy Volunteers | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Location Countries ICMJE | Germany, Switzerland | ||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT00878813 | ||||||||||||
Other Study ID Numbers ICMJE | KEK 001/09 | ||||||||||||
Has Data Monitoring Committee | No | ||||||||||||
Responsible Party | University Hospital Inselspital, Berne | ||||||||||||
Study Sponsor ICMJE | University Hospital Inselspital, Berne | ||||||||||||
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Investigators ICMJE |
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Information Provided By | University Hospital Inselspital, Berne | ||||||||||||
Verification Date | November 2011 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |