To examine the impact of remote ischaemic postconditioning after an ischaemic stroke on infarct size and clinical outcome in patients, but also to better understand the potential underlying mechanisms contributing to these effects.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in final infarct size between the intervention and control group.
Infarct size will be measured using MRI.
Secondary outcome
The primary outcome (infarct size) will be linked to our secondary outcomes:
Clinical outcome and vascular, immune, and anti-inflammatory pathways.
Background summary
Past decades, advances in pharmacological and endovascular treatment have
markedly improved outcome in patients with an ischaemic stroke. Nevertheless,
the therapeutic window to target, reduce and/or attenuate the detrimental
impact of ischaemic brain injury is limited (i.e. 6-hr after stroke), with no
subsequent treatment options available. This highlights the need for innovative
treatment options, which preferably extend beyond the first 6-hr post-stroke to
further attenuate brain damage. A possible solution to this problem is remote
ischaemic postconditoning (RIPostC), which is an application of brief
non-lethal periods of ischemia and reperfusion to activate innate responses
that leads to protection against prolonged periods of ischemia. This
intervention consists of inflation of a blood pressure cuff around the upper
arm. Recent research shows compelling evidence is present regarding the
benefits of repeated exposure to remote ischaemic conditioning after an
ischaemic event.
Study objective
To examine the impact of remote ischaemic postconditioning after an ischaemic
stroke on infarct size and clinical outcome in patients, but also to better
understand the potential underlying mechanisms contributing to these effects.
Study design
Randomized double blind clinical trial
Intervention
Remote RIPostC: 4 cycles of ischaemia of the arm by inflating a simple blood
pressure cuff around the upper arm at 20 mmHg above systolic blood pressure
during 5 minutes followed by 5 minutes of reperfusion. This will be performed
twice a day during the complete duration of hospitalization.
Study burden and risks
All techniques that will be applied in this study have been used several years
by the Department of Physiology and Neurology, some even longer than 15 years.
None of the procedures described above are *new* and all procedures are an
integrated part of several previous studies that have been accepted by the
ethics committee. To our best knowledge, none of the techniques applied in this
study have been associated with adverse effects. We believe that the risks of
the testing procedures of this study are minimal, while the subjects will be
monitored closely throughout the study.
Reinier postlaan 4
Nijmegen 6525 GC
NL
Reinier postlaan 4
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
Informed consent
Age >18 years
Clinically diagnosed ischaemic stroke using the WHO definition for stroke
Exclusion criteria
Unstable vital signs
Admitted >24 hours after onset of symptoms
Upper extremity injury or edema contra-indicating RIPostC.
Mastectomy on both sides
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 | NL62753.091.17 |