Stroke Clinical Trial
Official title:
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
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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