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Quantitative MR evaluation of vascular steal in AVM patients: a comparative study on normal subjects and on the longitudinal impact of endovascular treatment in AVM patient concerning neurocognition

Quantitative MR evaluation of vascular steal in AVM patients: a comparative study on normal subjects and on the longitudinal impact of endovascular treatment in AVM patient concerning neurocognition - Measurements of (effects of) cerebrovascular steal in AVM patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON31972
Enrollment
40
Registered
2008-09-15
Start date
2008-10-01
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

arteriovenous malformation vessel malformation of the brain

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: AVM patients with age between 18 and 55 years, considered eligible for endovascular treatment, with cerebral AVMs confined to a single hemisphere (the non-affected hemisphere will be used to assess within-patient control values of hemodynamic and quantitative MR parameters). Informed consent will be obtained from all patients. Control subjects will be matched to patients according to age and intelligence level. Inclusion criteria for control subjects: 1. healthy male or female subject with age between 18 and 55 years. 2. voluntary participation 3. having given their written informed consent 4. willing to accept use of all anonymized data, including publication, and the confidential use and storage of all data

Exclusion criteria

Exclusion criteria: Patients will be excluded from the investigation if they 1. manifest dural or multiple AVMs; 2. present with intracerebral haematomas, since the presence of intracerebral hematoma may interfere with preoperative neuropsychological testing. Further, resorption of the haematoma probably affects neurocognitive function (and distinction of this effect from treatment effect will pose problems, if possible at all). 3. suffer from any other central nervous system anomaly; 4. have a medical history of chronic drug or alcohol abuse. Exclusion criteria for control subjects: 1. having a current brain or vascular disease 2. claustrophobia 3. having metal implants or metal objects on the body which cannot be removed 4. mental of physical status that is incompatible with the proper conduct of the study 5. being under medication that may affect neurocognitive function

Design outcomes

Primary

MeasureTime frame
Primary study parameters are: - Cambridge Cognitive Examination (CAMCOG) total score controlled for mood/neuropsychiatric status (to evaluate global cognitive functioning), - cerebral blood volume, cerebral blood flow, mean transit time (to evaluate brain perfusion/vascular steal), - quantitative MR parameters (e.g. T1 and T2 relaxation times) (to evaluate structural abnormalities in brain parenchyma) - correlation between (changes in) neurocognitive functioning, (changes in) brain perfusion and (changes in) quantitative MR parameters, before and after endovascular treatment. - predictive value of pre-operative perfusion and quantitative MR parameters with regard to treatment effect on neurocognitive funtion in patiens

Secondary

MeasureTime frame
Secundary study parameters are: - Obliteration rate of the AVM after endovascular treatment.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)