1. To determine the diagnostic accuracy, in terms of detecting a vascular malformation, of CTA, MRI/MRA, DSA, or combinations thereof in patients with ICH?2. To find out which test or combination of tests is most effective for the detection of…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be the detection of a vascular malformation with a
(combination of) test(s) as expressed by means of the area under the receiver
operator characteristic curve.
Using a logistic regression model we will assess which (combination of) test(s)
discerns best between presence and absence of a vascular malformation.
Secondary outcome
The secondary outcome will be the effectiveness of the diagnostic tests,
separately and in combination, expressed as remaining life expectancy in good
health (independent) and the number of quality-adjusted lifeyears (QALY*s).
Background summary
Rationale:
Background. Spontaneous intracerebral haemorrhage (ICH) accounts for 10-15% of
all strokes. ICH may be caused by leakage from small vessels affected by
hypertension, by cerebral amyloid angiopathy, in particular in elderly
patients, or by bleeding from a vascular malformation. In patients younger than
45 years of age brain arteriovenous malfomation
(AVM) is the most common single cause of ICH. ICH can also be caused by rupture
of an aneurysm (without evident subarachnoid haemorrhage), by cavernous
angiomas, by venous angiomas, and by dural AVMs. Except for the specific group
of patients older that 45 year of age with ICH in the basal ganglia and a
history of hypertension, it is unknown which investigations should be done and
when in order to find or exclude a vascular malformation in patients with ICH.
Finding a vascular malformation has important prognostic and therapeutic
implications.
Study objective
1. To determine the diagnostic accuracy, in terms of detecting a vascular
malformation, of CTA, MRI/MRA, DSA, or combinations thereof in patients with
ICH?
2. To find out which test or combination of tests is most effective for the
detection of vascular malformations with effectiveness expressed as remaining
life expectancy in good health and expected numbers of quality-adjusted
life-years.
Study design
The study design will be a prospective cohort study of 300 patients with
spontaneous ICH. CTA will be performed in the acute phase, preferably
immediately after the CT-scan that showed the ICH, but at the latest 48 hours
after the ICH occurred. MRI/MRA is performed four or eight weeks after the ICH
occurred depending on the size of the ICH. If CTA and MRI/MRA have not shown
the cause of the ICH, a DSA will be performed within one week after the
MRI/MRA.
Study burden and risks
For participating patients there is no additional risk.
CTA, MRI/MRA and DSA are routine everyday investigations. DSA will only be
performed if the CTA and the MRI/MRA have not shown the cause of the ICH, to
prevent unnecessary exposure to the -albeit small- risk of the procedure.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Patients with spontaneous intracerebral haemorrhage (ICH) between 18 and 70 years of age.
Exclusion criteria
Patients between 45 and 70 years with a known history of hypertension and ICH in the thalamus, putamen, or posterior fossa will be excluded, as well as patients on oral anticoagulants with an INR greater than 2.5 and patients who will not be able to undergo (one of) the examinations because of contraindications.
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 | NL21285.041.08 |