Clinical trial NCT00975962: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Stroke
Keywords: Stroke
Neuroprotection
remote preconditioning
Salvage index (%): Difference in infarct growth (PWI-DWI)
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: TRYG Foundation
name: Aase and Ejnar Danielsens Foundation
name: Danish National Research Foundation
First posted: 2009-09-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Salvage index (%): Difference in infarct growth (PWI-DWI) after 24 hours among patients treated with preconditioning and those not treated.
timeFrame: February 2012
Secondary outcomes:
measure: Final size of the infarct (T2 MRI after 1 month). Final infarct size adjusted after prognostic factors.
timeFrame: February 2012
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Neurology, Aarhus University Hospital
Study officials:
affiliation: Department of Neurology Aarhus University Hospital
name: Grethe Andersen, M.D Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.