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NCT Number: NCT00975962

New Acute Treatment for Stroke - The Effect of Remote PERconditioning

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.

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Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Neurology, Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Significant ischemic stroke suspicion (NIHSS 1-24) and paresis of an extremity.
  • Treatment with rtPa within 4.5 hours from debut of symptoms.
  • Age above 18 (changed from 01.01.2010 to no upper age limit)
  • Independent in daily living before the acute onset of symptoms. (mrs</=2)
  • MR scan showing DWI lesion, consistent with acute ischemic stroke.

Exclusion criteria

  • Contraindications for iv rtPA
  • Onset of symptoms older than 4.5 hours
  • Previous diseases of the brain: Intracranial aneurisms or arteriovenous malformations. Brain surgery or hemorrhagic stroke. Former ischemic stroke within the last 3 months.
  • Heart diseases: Infectious endocarditis or suspicion of septic emboli, pericarditis, ventricular thrombosis, aneurisms of the heart wall or major heart failure.
  • Serious diseases: Cancer, AIDS, dementia, significant abuse, renal failure, liver diseases such as liver failure, cirrhosis, portal hypertension, active hepatitis.
  • Pregnancy
  • Major ischemic stroke where the patient is unconscious.(NIHSS > 25).
  • Symptoms suspect for migraine, Multiple sclerosis, TIA or another neurological disease than ischemic stroke.

MR scan:

  • Contraindications for MRI scans
  • Tumor cerebri, cerebral abscesses
  • Known hypersensitivity to Gadovist or any of its ingredients, acute or chronic severe renal impairment (GFR < 30 ml/min/1.73m2), acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
  • Caution with using Gadovist to patients with severe cardiovascular disease, and only to be used after a risk-benefit assessment.
  • Caution with using Gadovist in patients with low threshold for seizures.

Lab data:

  • Blood glucose < 2, 8 mmol/l or > 22 mmol/l

Treatment and study plan

Actilyse

Drug

Actilyse according to guidelines without pretreatment with remote persconditioning

Thrombolysis + remote perconditioning

Procedure

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.

Primary outcomes

  1. Salvage index (%): Difference in infarct growth (PWI-DWI) after 24 hours among patients treated with preconditioning and those not treated.

    Time frame: February 2012

Secondary outcomes

  1. Final size of the infarct (T2 MRI after 1 month). Final infarct size adjusted after prognostic factors.

    Time frame: February 2012

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Aase and Ejnar Danielsens Foundation
  • Danish National Research Foundation
  • TRYG Foundation

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 14, 2009
Registry last updated
Jun 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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