New Acute Treatment for Stroke - The Effect of Remote PERconditioning
1 other identifier
interventional
120
1 country
1
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:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 11, 2009
CompletedFirst Posted
Study publicly available on registry
September 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedJune 23, 2011
June 1, 2011
1.7 years
September 11, 2009
June 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Salvage index (%): Difference in infarct growth (PWI-DWI) after 24 hours among patients treated with preconditioning and those not treated.
February 2012
Secondary Outcomes (1)
Final size of the infarct (T2 MRI after 1 month). Final infarct size adjusted after prognostic factors.
February 2012
Study Arms (2)
Thrombolysis + Remote perconditioning
EXPERIMENTALRemote 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
ACTIVE COMPARATORThrombolysis without pretreatment with remote perconditioning
Interventions
Actilyse according to guidelines without pretreatment with remote persconditioning
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aarhus University Hospitallead
- TRYG Foundationcollaborator
- Aase and Ejnar Danielsens Foundationcollaborator
- Danish National Research Foundationcollaborator
Study Sites (1)
Department of Neurology, Aarhus University Hospital
Aarhus, Aarhus, 8000, Denmark
Related Publications (1)
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.
PMID: 24203849DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Grethe Andersen, M.D Doctor
Department of Neurology Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 11, 2009
First Posted
September 14, 2009
Study Start
July 1, 2009
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
June 23, 2011
Record last verified: 2011-06