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Clinical trials Stroke

Searching for new candidate genes for intracranial aneurysms using a genome wide association study

Researchers: F. vt Hof, Y.M. Ruigrok, G.J.E. Rinkel

A familiar predisposition is the strongest risk factor for the development of intracranial aneurysms, which suggests a genetic background for aneurysms. This study aims to identify new candidate genes for the development and the subsequent rupture of an aneurysm, using a combination of a genome wide association study and a genome wide expression study. Also, we will assess whether these candidate genes can be analyzed as biomarkers in blood of aneurysm patients. Finally, we suggest common genetic risk factors for different types of aneurysms (i.e., in this study intracranial aneurysms and aneurysms of the aorta). By identifying common genetic risk factors, the unraveling of the genetic background of the aneurysms in general may be accelerated.

Intracranial aneurysms- identifying patients at risk

Researchers: R.Kleinloog, Y.M. Ruigrok, B.H.Verweij, J.A.Post, L. Regli, G.J.E. Rinkel

SAH is a relatively rare subset of stroke. Rupture of intracranial aneurysms results in subarachnoid hemorrhage (SAH), which has a high case fatality rate of 50%. SAH is a relatively rare subset of stroke. However, with a prevalence of 3%, intracranial aneurysms are not rare. These aneurysms may give rise to SAH in the near or distant future, but our abilities to predict which aneurysms are going to rupture and when are very limited. The overall aim of this study is to gain insight in the development and rupture rate of aneurysms and to detect potential markers that predict the risk of aneurysm rupture. For that we will use a unique combination of genomics and ultrastructural electron microscopy research to unravel the molecular and cellular processes involved in the development and subsequent rupture of intracranial aneurysms. In addition, we translate these findings to clinical practice by relating the ultra-structural markers identified to high-resolution 7T MRI flow, aneurysm and aneurysmal wall characteristics in aneurysm patients.

Screening and follow-up of familial and unruptured intracranial aneurysms

Researchers: A.S.E. Bor, M.J.H. Wermer, G.J.E. Rinkel

Aneurysms develop and grow during life. This study assesses the yield, efficiency and cost-effectiveness of long term, serial screening in persons with a family history of aneurysmal subarachnoid hemorrhage. Since small aneurysms are often left untreated, we also study the yield of serial follow up using imaging in patients with small un ruptured aneurysms and determinants of future growth, with focus on both patient and aneurysm characteristics. The latter include configuration of the aneurysms and adjacent vessels.

The risk of rupture and the risk of treatment of unruptured intracranial aneurysms

Researchers: D. Backes, M.D.I. Vergouwen, G.J.E. Rinkel

Approximately 3% of the general population has an intracranial aneurysm. The treatment of these unruptured aneurysms remains controversial and is based on weighing the balance between rupturenrisk and the risk of treatment complications. Only a couple of risk factors for aneurysm rupture are known, and risk prediction is poor. This study aims to identify new risk factors for rupture of unruptured intracranial aneurysms and to give insight in the safety of treatment of unruptured intracranial aneurysms in the Netherlands.

BASICS (Intra-arterial intervention in the acute stage of basilar artery thrombosis)

Researchers: E. van der Hoeven, W. Schonewille, A. Algra, J. Kappelle

In a multicenter international study, patients with symptoms and signs compatible with ischemia in the basilar artery, who have a basilar artery occlusion confirmed by CTA or MRA and are suitable for endovascular intervention within 6 hours of estimated time of basilar artery occlusion, are randomized between intravenous thrombolysis or intravenous thrombolysis followed by intra-arterial therapy.

CT perfusion in aneurysmal subarachnoid hemorrhage

Researchers: C.H.P. Cremers, I.C. van der Schaaf, M.D.I. Vergouwen, B.K. Velthuis, G.J.E. Rinkel

In this study we investigate the value of CT perfusion (CTP) in patients with aneurysmal subarachnoid hemorrhage (SAH). First, we review the literature on the relationship between CT perfusion and the development of delayed cerebral ischemia (DCI). Subsequently, we investigate if a delay-insensitive CTP algorithm is more reliable than a delay-sensitive CTP algorithm in detecting DCI after SAH. In addition, we will determine threshold values to differentiate between patients with DCI and patients without DCI and between reversible and irreversible DCI. Finally, we will investigate the relationship between perfusion measured on admission and cognitive outcome 3 months after SAH.

VAST- Vertebral Artery Stenting Trial

Researchers: A .Compter, A. Algra, J. Kappelle, W. Schonewille, R. Lo, F. Moll, W. Mali, B. van der Worp

The primary aim of the VAST is to assess whether stenting for symptomatic vertebral artery stenosis ≥ 50% is both feasible and safe. A secondary aim is to assess the rate of stroke in the territory of the vertebrobasilar arteries in patients with symptomatic vertebral artery stenosis ≥ 50% on best medical therapy with or without stenting. VAST is a randomized, open clinical trial with blinded outcome assessment. The trial will include a total of 180 patients with TIA or non-disabling ischemic stroke that has been attributed to vertebral artery stenosis of at least 50%. The primary outcome is any stroke, vascular death, or non-fatal myocardial infarction within 30 days after start of treatment.

This study is done in collaboration with St. Antonius Hospital, Nieuwegein, the Academic Medical Center Amsterdam, UMC Groningen, Maastricht UMC and Haga Hospital, The Hague.

COOLIST-COOLing for Ischaemic Stroke Trial

Researchers: M. Geurts, J. Kappelle, A. Algra, B. van der Worp

In COOLIST the feasibility and safety of surface cooling to 34, 34.5, and 35˚C, started within 4.5 hours after the onset of acute ischemic stroke and maintained for 24 hours, are compared in 48 awake patients on a stroke unit. The design is that of a randomized, open, multi-center, phase II clinical trial with masked outcome assessment. The primary outcome measure is feasibility, defined as the number of patients that has successfully completed the treatment strategy they had been assigned to. The study will provide information on the feasibility and safety of different surface cooling strategies on a stroke unit. A validation study, in which the two most promising treatment strategies will be assessed again, is anticipated. The results of the present trial and those of the validation trial will inform a conclusive phase III trial of surface cooling for acute ischemic stroke.

The study is carried out in collaboration with Skåne University Hospital Malmo, Sweden, UMC Groningen and the Erasmus MC Medical Center Rotterdam.

EuroHYP-1-European multicenter, randomized, phase III clinical trial of therapeutic hypothermia plus best medical treatment versus best medical treatment alone for acute ischemic stroke

Researcher: B. van der Worp

EuroHYP-1 aims to determine whether systemic cooling to a target body temperature between 34.0 and 35.0°C, started within 6 hours of symptom onset and maintained for 24 hours, improves functional outcome at 3 months in patients with acute ischemic stroke. This is a multi-center, phase III, randomized, open-label clinical trial with blinded outcome assessment in 1500 patients with acute ischemic stroke. The primary outcome measure is the score on the modified Rankin Scale (mRS) at 91 days, as analyzed with ordinal logistic regression and expressed as a common odds ratio.

This study is performed in collaboration with University Medical Center Erlangen, Germany (coordinating center); Copenhagen University Hospital Bispebjerg, Denmark University of Edinburgh, UK. Skåne University Hospital Malmo, Sweden and about 50 other medical centers throughout Europe.

PAIS 2-Paracetamol (Acetaminophen) in Stroke 2

Researchers: A. Algra, J. Kappelle, B. van der Worp

PAIS 2 will assess the effect of high-dose paracetamol on functional outcome in patients with acute stroke and a body temperature of 36.5°C or above. This is a multicenter, randomized, double-blind, placebo-controlled clinical trial in 1500 patients with acute ischemic stroke or intracerebral hemorrhage within 12 hours of symptom onset. The primary outcome is improvement on the modified Rankin Scale at 3 months, assessed with multivariable ordinal logistic regression. When prevention of an increase in body temperature with high-dose paracetamol will improve functional recovery after acute stroke, a simple, safe and very cheap therapy will be available for many patients with stroke worldwide.

This is part of a large study coordinated by the Erasmus MC Medical Center Rotterdam, involving 9 other medical centers in the Netherlands.

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