DIagnostic AngioGRAphy to find vascular Malformations (DIAGRAM study) in patients with spontaneous intracerebral haemorrhage

DIagnostic AngioGRAphy to find vascular Malformations (DIAGRAM study) in patients with spontaneous intracerebral haemorrhage - Detection of vascular malformations after intracerebral haemorrhage

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39633

Enrollment

300

Registered

2008-07-01

Start date

2008-07-14

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intracerebral haemorrhage stroke

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with spontaneous intracerebral haemorrhage (ICH) between 18 and 70 years of age.

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Countries

Netherlands

Outcome results