No registrations found.
ID
Source
Brief title
Health condition
Unruptured intracranial Aneurysms.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cardiac-cycle related pulsatile motion of the intracranial aneurysm wall in individual aneurysms.
Secondary outcome
-
Background summary
Rationale: Intracranial aneurysm (IA) wall motion is proposed to indicate locations with reduced stability. If reliable measurements of the pulsatility could be performed, increased pulsatile wall motion could be a valuable addition to the current rupture risk estimation. The magnitude of the pulsations is unknown, impeding the validation of IA pulsations. Therefore, a validated measurement of the IA pulsation is required.
Objective: Detecting and quantifying the cardiac cycle-related pulsatility of the intracranial aneurysm wall with 4D CTA.
Study design: Observational pilot study.
Study population: Adult patients admitted to the Radboud UMC for the follow-up of unruptured and untreated intracranial aneurysms.
Main study parameters/endpoints: Cardiac-cycle related pulsatile motion of the intracranial aneurysm wall.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: A radiation dose of approximately 3 mSv is added. This study contributes towards a refined rupture risk estimated in patients with unruptured and untreated aneurysms.
Study objective
Pulsatile wall movement can be quantified with 4D CTA.
Study design
In December and Januari, 15 patients are scanned with a 4D CTA scanner. These scans are analyzed in batches of 3 to 5 patients for the primary outcome. The data analysis is performed in Matlab, using a costum made algorithm.
Intervention
-
Inclusion criteria
1. Adult patients with untreated and unruptured intracranial aneurysm(s).
2. Planned for a follow-up scan in the Radboud UMC
3. Informed consent.
Exclusion criteria
1. Contra-indications for CT or contrast agent (pregnant, allergic to contrast agent)
2. Aged below 18 years or mentally incompetent.
3. Patients with impaired kidney function, at least eGFR <60 ml/min/1.73m2;
4. Patients with treated aneurysm at similar height of the untreated and unruptured aneurysm
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL8936 |
| Other | METC Arnhem-Nijmegen : 2020-6980 |