The main objective of this study is to detect occurrence of SECI after trans-radial access in interventional radiology procedures. The secondary objective is to determine if there is a difference in the incidence of silent stroke after approach…
ID
Source
Brief title
Condition
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quantify the prevalence of SECI after transradial interventional radiology
procedures using MRI.
Secondary outcome
Secondary Objective(s): Difference in SECI between right- or left-sided radial
access.
Background summary
Traditionally, endovascular access for interventional radiology procedures is
obtained by trans-femoral access (TFA) providing access to virtually all
vascular territories. Trans-radial access (TRA) and even distal radial access
(DRA) are increasingly used as alternative access methods. Access through the
radial artery has shown lower major complication rates, earlier mobilization
and discharge, reduced costs and better patient satisfaction compared to TFA.
Acute stroke is a rare complication following radial access demonstrated in
coronary interventions, but asymptomatic thromboembolic events, silent embolic
cerebral infarctions (SECI), are more prevalent. Silent infarcts are associated
with adverse cognitive and neurological consequences.
However, in abdominal interventional radiology procedures, the aortic arch is
only passed once, without exchange of the catheters in contrast to percutaneous
coronary interventions in which (guiding) catheters are frequently exchanged.
Therefore, the likelihood of silent embolic cerebral infarctions in
interventional radiology is theoretically lower. The main objective of this
study is to prospectively quantify the occurrence of SECI using magnetic
resonance imaging (MRI) in interventional radiology procedures.
Study objective
The main objective of this study is to detect occurrence of SECI after
trans-radial access in interventional radiology procedures. The secondary
objective is to determine if there is a difference in the incidence of silent
stroke after approach through the left or the right radial artery.
Study design
Observational study.
Study burden and risks
Subjects will undergo a MRI study consisting of a DWI, T2W and a FLAIR
sequence. No contrast agent will be given. There is no significant health risk
or suspected benefit in MR imaging. This MRI will be performed within three
days after the interventional radiology procedure. No additional hospital
visits are required. Some patients experience claustrophobia during MR imaging,
possibly causing physiological discomfort.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Informed consent
Age > 18 years old
Scheduled for either:
Transarterial chemo embolization (TACE)
Transarterial radio embolization (TARE; both Y90 admission as Y-90
pre-treatment angiography)
Angioplasty or stent placement in the mesenteric or renal
Embolization of the renal, hepatic, splenic of mesenteric arteries
Exclusion criteria
Contra-indication for MRI (including claustrophobia)
Radial artery diameter: <1.8 mm
Barbeau type D (insufficient palmar arch)
Not able to given written informed consent
Hemodynamically unstable patients
History of stroke or transient ischemic attack (TIA)
Legally incompetent adults
insufficient command of the Dutch language.
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 | NL70647.078.19 |