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Added value of hemodynamics for rupture risk assessment of intracranial aneurysms

Added value of hemodynamics for rupture risk assessment of intracranial aneurysms - HEROICA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON32509
Enrollment
168
Registered
2008-11-12
Start date
2008-12-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

balloon-like dilatation of blood vessels in the brain intracranial aneurysm

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -patients with ruptured aneurysms, who received an endovascular treatment in one of the participating centers, between August 1st 2008 and December 1st 2010. -patients with unruptured and untreated aneurysms, whose aneurysms where found incidentally in one of the participating centers -patients with an aneurysm who underwent a 3D rotational angiography as part of the standard clinical care. -age between 18-75 -Glasgow Outcome Score(GOS) full recovery/ moderate disability -written informed consent

Exclusion criteria

Exclusion criteria: Contraindications for MRI (pacemakers, claustrophobia etc. ) previous surgical treatment of an aneurysm with neurosurgical clips

Design outcomes

Primary

MeasureTime frame
Study parameters: 1) MRI measurements of flow velocity (in cm/s) in blood vessels proximal and distal of intracranial aneurysms. 2) Development of patient-specific hemodynamic models using CFD. 3) Geometrical data acquired through 3D rotational angiography. Endpoints: 1) The influence of the 4 geometric and 4 hemodynamic parameters on aneurysm rupture status. 2) The relative contribution of the individual parameters (all parameters as independents) in predicting aneurysm rupture status (dependent), 3) Selection of parameters to build models in which aneurysm rupture can be best predicted.

Secondary

MeasureTime frame
Secundary study parameters: development of patient-specific hemodynamic models using CFD Secundary outcome: selection of characteristics to build models in which aneurysm rupture can be best predicted.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)