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| Name | Class |
|---|---|
| TRYG Foundation | OTHER |
| Aase and Ejnar Danielsens Foundation | OTHER |
| Danish National Research Foundation | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thrombolysis + Remote perconditioning | Experimental | 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 | Active Comparator | Thrombolysis without pretreatment with remote perconditioning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actilyse | Drug | Actilyse according to guidelines without pretreatment with remote persconditioning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Salvage index (%): Difference in infarct growth (PWI-DWI) after 24 hours among patients treated with preconditioning and those not treated. | February 2012 |
| Measure | Description | Time Frame |
|---|---|---|
| Final size of the infarct (T2 MRI after 1 month). Final infarct size adjusted after prognostic factors. | February 2012 |
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Inclusion Criteria:
Exclusion Criteria:
MR scan:
Lab data:
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| Name | Affiliation | Role |
|---|---|---|
| Grethe Andersen, M.D Doctor | Department of Neurology Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Aarhus University Hospital | Aarhus | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24203849 | Derived | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D005343 | Fibrinolytic Agents |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Thrombolysis + remote perconditioning | Procedure | 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. |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
| D050299 | Fibrin Modulating Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D006401 | Hematologic Agents |