Status:
COMPLETED
New Acute Treatment for Stroke - The Effect of Remote PERconditioning
Lead Sponsor:
Aarhus University Hospital
Collaborating Sponsors:
TRYG Foundation
Aase and Ejnar Danielsens Foundation
Conditions:
Acute Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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' hy...
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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00975962
Start Date
July 1 2009
End Date
March 1 2011
Last Update
June 23 2011
Active Locations (1)
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1
Department of Neurology, Aarhus University Hospital
Aarhus, Aarhus, Denmark, 8000