New Acute Treatment for Stroke - The Effect of Remote PERconditioning

Completed

Phase 3 Results N/A

Trial Description

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

Interventions

  • Actilyse Drug
    Other Names: Alteplase
    Intervention Desc: Actilyse according to guidelines without pretreatment with remote persconditioning
    ARM 1: Kind: Experimental
    Label: Thrombolysis
    Description: Thrombolysis without pretreatment with remote perconditioning
  • Thrombolysis + remote perconditioning Procedure
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Thrombolysis + Remote perconditioning
    Description: Remote perconditioning (rIPerC) undertaken in ambulance on rute to hospital in case of suspected stroke. 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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Salvage index (%): Difference in infarct growth (PWI-DWI) after 24 hours among patients treated with preconditioning and those not treated. February 2012 No
Secondary Final size of the infarct (T2 MRI after 1 month). Final infarct size adjusted after prognostic factors. February 2012 No

Sponsors