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New Acute Treatment for Stroke - The Effect of Remote PERconditioning

Primary Purpose

Acute Stroke

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Actilyse
Thrombolysis + remote perconditioning
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Stroke focused on measuring Stroke, Neuroprotection, remote preconditioning, Salvage index (%): Difference in infarct growth (PWI-DWI)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neurology, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thrombolysis + Remote perconditioning

Thrombolysis

Arm 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.

Thrombolysis without pretreatment with remote perconditioning

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 11, 2009
Last Updated
June 22, 2011
Sponsor
Aarhus University Hospital
Collaborators
TRYG Foundation, Aase and Ejnar Danielsens Foundation, Danish National Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00975962
Brief Title
New Acute Treatment for Stroke - The Effect of Remote PERconditioning
Official Title
New Acute Treatment for Stroke - The Effect of Remote PERconditioning
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Aarhus University Hospital
Collaborators
TRYG Foundation, Aase and Ejnar Danielsens Foundation, Danish National Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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: To describe method of remote perconditioning in clinical practice regarding feasibility. Pros and cons and potential limitations. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
Stroke, Neuroprotection, remote preconditioning, Salvage index (%): Difference in infarct growth (PWI-DWI)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thrombolysis + Remote perconditioning
Arm Type
Experimental
Arm 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.
Arm Title
Thrombolysis
Arm Type
Active Comparator
Arm Description
Thrombolysis without pretreatment with remote perconditioning
Intervention Type
Drug
Intervention Name(s)
Actilyse
Intervention Description
Actilyse according to guidelines without pretreatment with remote persconditioning
Intervention Type
Procedure
Intervention Name(s)
Thrombolysis + remote perconditioning
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Final size of the infarct (T2 MRI after 1 month). Final infarct size adjusted after prognostic factors.
Time Frame
February 2012

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grethe Andersen, M.D Doctor
Organizational Affiliation
Department of Neurology Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
24203849
Citation
Hougaard KD, Hjort N, Zeidler D, Sorensen L, Norgaard A, Hansen TM, von Weitzel-Mudersbach P, Simonsen CZ, Damgaard D, Gottrup H, Svendsen K, Rasmussen PV, Ribe LR, Mikkelsen IK, Nagenthiraja K, Cho TH, Redington AN, Botker HE, Ostergaard L, Mouridsen K, Andersen G. Remote ischemic perconditioning as an adjunct therapy to thrombolysis in patients with acute ischemic stroke: a randomized trial. Stroke. 2014 Jan;45(1):159-67. doi: 10.1161/STROKEAHA.113.001346. Epub 2013 Nov 7.
Results Reference
derived

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New Acute Treatment for Stroke - The Effect of Remote PERconditioning

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