New Acute Treatment for Stroke - The Effect of Remote PERconditioning

June 22, 2011 updated by: Aarhus University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Neurology, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thrombolysis + Remote perconditioning

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.
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.
Active Comparator: Thrombolysis
Thrombolysis without pretreatment with remote perconditioning
Drug: Actilyse
Actilyse according to guidelines without pretreatment with remote persconditioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Salvage index (%): Difference in infarct growth (PWI-DWI) after 24 hours among patients treated with preconditioning and those not treated.
Time Frame: February 2012
February 2012

Secondary Outcome Measures

Outcome Measure
Time Frame
Final size of the infarct (T2 MRI after 1 month). Final infarct size adjusted after prognostic factors.
Time Frame: February 2012
February 2012

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Collaborators

TRYG Foundation
Danish National Research Foundation
Aase and Ejnar Danielsens Foundation

Investigators

  • Principal Investigator: Grethe Andersen, M.D Doctor, Department of Neurology Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

September 11, 2009

First Submitted That Met QC Criteria

September 11, 2009

First Posted (Estimate)

September 14, 2009

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEK 19752

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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