|- candidate number||28322|
|- NTR Number||NTR6880|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-dec-2017|
|- Secondary IDs||2017-3711 CMO regio Arnhem-Nijmegen|
|- Public Title||The effect of repeated remote ischaemic postconditioning on infarct size in stroke patients. |
|- Scientific Title||A randomized clinical trial to assess the effect of repeated remote ischaemic postconditioning on infarct size in patients with an ischaemic stroke’|
|- hypothesis||The hypothesis is that repeated remote ischaemic postconditioning (by improving vascular, immune and anti-inflammatory pathways) will minimize infarct size and, subsequently, will improve clinical outcome in stroke patients. |
|- Healt Condition(s) or Problem(s) studied||Stroke, Stroke, Ischemic stroke|
|- Inclusion criteria||- Informed consent|
- Age >18 years
- Clinically diagnosed ischaemic stroke using the WHO definition for stroke (“Stroke was defined as a rapidly evolving focal neurological deficit, without positive phenomena such as twitches, jerks or myoclonus, with no other than a vascular cause”).
|- Exclusion criteria||Unstable vital signs |
Admitted >24 hours after onset of symptoms
Upper extremity injury or edema contra-indicating remote ischaemic conditioning
Mastectomy on both sides
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2018|
|- planned closingdate||2-feb-2021|
|- Target number of participants||200|
|- Interventions||Repeated remote ischaemic postconditioning (RIPostC): 4 cycles of ischaemia of the arm by inflating a blood pressure cuff around the upper arm at 20 mmHg above systolic blood pressure during 5 minutes followed by 5 minutes of reperfusion. This procedure will be performed twice a day (morning and afternoon) during the complete duration of hospitalization after the ischaemic stroke. The intervention will be administered by a trained researcher.|
|- Primary outcome||To examine the impact of repeated daily remote ischaemic postconditioning, starting on the day of an ischaemic stroke on infarct size after 4 days or at the end of hospitalization (using MRI). |
|- Secondary outcome||Explore the effect of repeated daily remote ischaemic postconditioning on clinical outcome after 12 weeks (using the modified ranking score; degree of disability/dependence).
Assess the impact of repeated daily remote ischaemic postconditioning on validated and frequently used markers of vascular, immune, and anti-inflammatory pathways, and relate these effects to total infarct size and clinical outcome.
|- Timepoints||Day of stroke: Baseline measurements for markers of vasculari, immune and anti-inflammatory pathways. informed consent.
Day1-4: Intervention twice daily.
Four days past stroke or at the end of hospitalization: Infarct size, blood sampling, clinical outcome in acute setting (NIHSS)
Twelve weeks: Clinical outcome (modified ranking score), Quality of life (SS-QoL)
Twelve months: Clinical outcome (modified ranking score), hospitalization, morbidity and mortality.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dhr., MSc T.R.J. Landman|
|- CONTACT for SCIENTIFIC QUERIES||Dhr., MSc T.R.J. Landman|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Radboud University Medical Center Nijmegen|
|- Brief summary||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 single blind placebo-controlled clinical trial
Study population: 200 patients with ischaemic stroke who are being admitted to the emergency room of the Radboudumc.
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.
Main study parameters/endpoints: Difference in final infarct size between the intervention and control group. Infarct size will be measured using MRI. This primary outcome will be linked to our secondary outcomes: Clinical outcome and vascular, immune, and anti-inflammatory pathways.
|- Main changes (audit trail)|
|- RECORD||8-dec-2017 - 2-jul-2018|