New Acute Treatment for Stroke - The Effect of Remote PERconditioning

This study has been completed.
Sponsor:
Collaborators:
TRYG Foundation
Aase and Ejnar Danielsens Foundation
Danish National Research Foundation
Information provided by:
Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT00975962
First received: September 11, 2009
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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.

Condition Intervention Phase
Acute Stroke
Drug: Actilyse
Procedure: Thrombolysis + remote perconditioning
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: New Acute Treatment for Stroke - The Effect of Remote PERconditioning

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Salvage index (%): Difference in infarct growth (PWI-DWI) after 24 hours among patients treated with preconditioning and those not treated. [ Time Frame: February 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Final size of the infarct (T2 MRI after 1 month). Final infarct size adjusted after prognostic factors. [ Time Frame: February 2012 ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: July 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975962

Locations
Denmark
Department of Neurology, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
TRYG Foundation
Aase and Ejnar Danielsens Foundation
Danish National Research Foundation
Investigators
Principal Investigator: Grethe Andersen, M.D Doctor Department of Neurology Aarhus University Hospital
  More Information

No publications provided by Aarhus University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Grethe Andersen M.D doctor, Department of Neurology Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00975962     History of Changes
Other Study ID Numbers: VEK 19752
Study First Received: September 11, 2009
Last Updated: June 22, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Aarhus University Hospital:
Stroke
Neuroprotection
remote preconditioning
Salvage index (%): Difference in infarct growth (PWI-DWI)

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on July 23, 2014