NCT00975962

New Acute Treatment for Stroke - The Effect of Remote PERconditioning

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a blinded randomized study. Randomization for treatment/not treatment with remote perconditioning takes place during transportation to the hospital. This is because the investigators' hypothesis states that remote perconditioning is neuro-protective and the effect is proportionally larger with early treatment. As the size of the effect is unknown, the investigators will use multiple magnetic resonance imaging (MRI) scans to determine the size of a potential neuro-protective effect. The aims of this study are: 1. To describe method of remote perconditioning in clinical practice regarding feasibility. Pros and cons and potential limitations. 2. To estimate the size of the effect of remote perconditioning in combination with recombinant tissue plasminogen activator (rtPa) treatment within four and a half hours of onset of symptoms.

Detailed description

Final inclusion and informed consent takes place after first MRI in patients eligible for rtPA. Follow-up MRI after 24h and 1 month. Clinical outcome at 3 months.

Conditions

• Acute Stroke

Interventions

Type	Name	Description
DRUG	Actilyse	Actilyse according to guidelines without pretreatment with remote persconditioning
PROCEDURE	Thrombolysis + remote perconditioning	The rIPerC consists of 4 cycles of 5 minute total occlusion of blood flow to the non-paretic arm separated by 5 minutes of reperfusion. The occlusion is secured by inflating a standard blood pressure cuff to 25 mmHg above the systolic blood pressure. Written instruction on cuff inflation and paramedic's documentation of their procedure were written in a standard report which was turned over to a study nurse upon arrival to the hospital, and filed. The investigators were hence blinded to the prehospital rIPerC.

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2009-09-14
• Last updated: 2011-06-23

Locations

1 site across 1 country: Denmark