New Acute Treatment for Stroke - The Effect of Remote PERconditioning

Acute Stroke Clinical Trial

Official title:

New Acute Treatment for Stroke - The Effect of Remote PERconditioning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00975962
• Other study ID #: VEK 19752
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2009
• Last updated: June 22, 2011
• Start date: July 2009
• Est. completion date: March 2011

Study information

• Verified date: June 2011
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Drug:
• Actilyse
Actilyse according to guidelines without pretreatment with remote persconditioning

Procedure:
• Thrombolysis + remote perconditioning
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.

Locations

Country	Name	City	State
Denmark	Department of Neurology, Aarhus University Hospital	Aarhus

Sponsors (4)

Lead Sponsor	Collaborator
Aarhus University Hospital	Aase and Ejnar Danielsens Foundation, Danish National Research Foundation, TRYG Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salvage index (%): Difference in infarct growth (PWI-DWI) after 24 hours among patients treated with preconditioning and those not treated.		February 2012	No
Secondary	Final size of the infarct (T2 MRI after 1 month). Final infarct size adjusted after prognostic factors.		February 2012	No