The main goal of the current 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.
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. differences in gene expression of ruptured and unruptured aneurysmal
biopsies and control tissue
2. changes in cell types or vessel wall components of ruptured and unruptured
aneurysmal biopsies and control tissue
3. correlation of the expression of proteins of interest with the size/stage of
development of the aneurysm.
Secondary outcome
not applicable
Background summary
Most intracranial aneurysms are discovered after rupture. Rupture results in
subarachnoid hemorrhage (SAH), which has a case fatality rate of 50%. With
greater availability and higher accuracy of the imaging techniques, unruptured
intracranial aneurysms are increasingly being discovered. 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. It is not
rational to treat all intracranial aneurysms, because treatment carries a risk
of around 5% of complications leading to death or dependence on help for
activities of daily living. Thus for a tailored approach markers associated
with rupture in individual patients are urgently needed.
Study objective
The main goal of the current 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.
Study design
This is an observational study with invasive measuring (taking blood and tissue
biopsies)
Study burden and risks
In patients with a unruptured or ruptured intracranial aneurysm who need
surgical clipping respectively 1 or 2 times 18 cc of blood will be drawn and
during surgical clipping a biopsy of the aneurysm, skin and the superficial
temporal artery will be taken. The excision of a small biopsy of the aneurysmal
wall takes places routinely during the surgical procedure of clipping of the
aneurysm. If a neurosurgeon decides during the surgical procedure that such an
excision is not indicated then the excision will not take place, also when a
patient is participating in our study. During the start of the surgical
procedure the neurosurgeon will excise a small sample of skin and a small
sample of an extracranial artery (superficial temporal artery) upon opening the
skin. In patients with a unruptured or ruptured intracranial aneurysm who need
coiling respectively 1 or 2 times 18 cc of blood will be drawn and during
coiling a small biopsy of the skin from the inner side of the upper arm is
taken using a *stansje* which is a device that will be pressed into the skin by
which a small part of the skin is released. For the control subjects one time
18 cc of blood will be drawn. This will be drawn from an existing
intra-arterial or intravenous line, present for the anaesthesia. After
resection of the brain tissue a small artery will be resected from this tissue.
The participation of the patients to the study will take place during their
admission in the hospital. Participation in this study will not have a direct
advantage for the participating patients. However, by participation the
patients will make an important contribution to the research on the cause of
the development and rupture rate of aneurysms.
The goal of our study is to gain insight in the development and rupture rate of
aneurysms and to detect potential markers associated with the risk of aneurysm
rupture. Since we aim these potential biomarkers to be applicable to the group
of patients with ruptured and unruptured aneurysms as a whole, we intend to
include all patients with a ruptured or unruptured intracranial aneurysm
needing treatment by surgical clipping or coiling admitted to the UMC Utrecht,
including those patients with a ruptured aneurysm and a reduced level of
consciousness. For those patients with a ruptured aneurysm and a reduced level
of consciousness needing treatment by surgical clipping or coiling the risks of
participating in this study are minimal.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Patients of age 18 years or older with a ruptured or unruptured intracranial aneurysm who need surgical clipping (N=70) or endovascular coiling (N=70) to treat the aneurysm.;For the control group: patients of age 16 years or older with therapy resistant epilepsy who need epilepsy surgery with brain resection (N=70).
Exclusion criteria
Patients with a ruptured or unruptured intracranial aneurysm who will not undergo treatment of the aneurysm or who are under the age of 18 years.;For the control group: Patients with therapy resistant epilepsy who need epilepsy surgery with brain resection who are under the age of 16 years or who have an intracranial aneurysm or other vascular malformation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33160.041.10 |