New Acute Treatment for Stroke - The Effect of Remote PERconditioning
Acute Stroke
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
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
Experimental
Active Comparator
Thrombolysis + Remote perconditioning
Thrombolysis
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