Objective 1)To determine the cost-effectiveness of screening for and preventive treatment of UIAs in persons with FDRs with UIAs. We will therefore assess the prevalence of UIA in persons with >=1 FDR with an UIA, the costs of the screening, the…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Objective 1)
- the prevalence of UIA in persons with >=1 FDR with an UIA
Objective 2)
- the prevalence of potential risk factors for UIA development in persons with
>=1 FDR with an UIA
Objective 3)
- the prevalence of UIA in persons with >=1 FDR with an UIA
Secondary outcome
Objective 1)
- costs of screening for and preventive treatment of UIA
- clinical outcome after preventive treatment of an UIA identified with
screening
- decision model studying cost-effectiveness expressed in costs per QALY
Objective 2)
- prediction model of risk of UIA in persons with >=1 FDR with an UIA
Objective 3)
- correlation of imaging markers on 3T and 7T MRA and biopsy findings of the
UIA wall
Background summary
Rupture of an intracranial aneurysm (IA) results in an aneurysmal subarachnoid
hemorrhage (aSAH), a subset of stroke occurring at relatively young age and
more often in women. It carries a high case morbidity and fatality, and has a
high socioeconomic burden. Lifetime risk of aSAH in the general population is
highest for persons with a positive family history for aSAH. Screening with
Magnetic Resonance Angiography (MRA) can detect unruptured IAs (UIAs), which
can then be treated to prevent future aSAH. Currently, only for first degree
relatives (FDRs) of aSAH patients there is evidence that screening is
effective. For FDRs of patients with UIAs (which occur in 3% of the population)
studies on effectiveness of screening have not been performed. Also, the
efficiency of the current screening strategy could be improved by identifying
high-risk individuals better. This identification could be improved by new
additional imaging markers for UIA development. Our aim is 1. to determine the
benefits and risks of screening for UIAs within persons with FDRs with UIA; 2.
to determine if persons with FDRs with UIA can be divided in groups with a
different risk for UIA development and 3. to assess potential imaging markers
for UIA development.
Study objective
Objective 1)
To determine the cost-effectiveness of screening for and preventive treatment
of UIAs in persons with FDRs with UIAs.
We will therefore assess the prevalence of UIA in persons with >=1 FDR with an
UIA, the costs of the screening, the effects of screening in terms of numbers
of life years in good quality of life gained by preventing aSAH and the number
of quality adjusted life years (QALYs) lost through side effects of screening
Objective 2)
To determine if persons with FDRs with UIA can be divided in groups with a
different risk for UIA development based on risk factors. We will therefore
assess the prevalence of potential risk factors for UIA development in persons
with >=1 FDR with an UIA.
Objective 3)
To assess potential imaging markers for UIA development on 3T and 7T MRA.
Study design
A monocenter observational prospective screening cohort study in first degree
family members of a consecutive series of index patients with UIA. Costs and
effects will be determined by means of a modeling approach.
Study burden and risks
The burden associated with participation consists of one MRA, six times an
E-questionnaire about quality of life, 1-2 times blood pressure measurement
(depending on result of screening MRA), 0-1 times physical examination
(depending on the result of the screening MRA) and an additional MRA in case of
positive screen (optional). Participants will be invited to visit the
outpatient clinic 1-5 times during this study (depending on the result of the
screening MRA).
We believe that the risks associated with participation are small, since the
procedures used are common in daily clinical practice. This outweighs the
relevance of this study for future screening in this patientcohort.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Age between 20 and 70 years
- At least one first degree relative with an unruptured intracranial aneurysm
identified by MRA, CTA or conventional angiography
Exclusion criteria
- People who do not speak Dutch well enough to give informed consent
- Any first degree relative with an aneurysmal subarachnoid hemorrhage
- A history of an aneurysmal subarachnoid hemorrhage and/or unruptured
intracranial aneurysm
- A history of polycystic kidney disease, Ehlers-Danlos, or fibromuscular
dysplasia
- Relative contraindication(s) for MRA, e.g. pregnancy, an internal metal
device such as a pacemaker, or claustrophobia
- A serious condition that would interfere with the treatment of an UIA, e.g.
severe comorbidity or reduced life expectancy
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 | NL59910.041.16 |