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See above. 3 patients left to include.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Ischemic per-postconditioning | Active Comparator | Remote conditioning is induced by inflation of a blood pressure cuff around the left thigh to 200 mmHg or 20 mmHg above systolic blood pressure (if >180 mmHg) for 5 min followed by deflation for 5 min. At least one of these conditioning cycles is performed before PCI is initiated. If time allows, cycles of remote conditioning (5 min leg ischemia and 5 min reperfusion) are repeated until PCI is performed. Following reperfusion, defined as first balloon inflation, four additional cycles of remote conditioning will be performed. |
|
| Sham | Sham Comparator | The sham procedures include application of the cuff around the thigh but it is not inflated. Otheriwize normal primary PCI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary Percutaneous Coronary Intervention | Procedure | Primary Percutanous Coronary Intervention is performed in both Groups. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance | 4-7 days following index event |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial infarct size expressed as a percentage to the myocardium at risk determined by Cardiac Magnetic Resonance | 6 months following index event |
| Measure | Description | Time Frame |
|---|---|---|
| Global left ventricular function determined by left ventricular ejection fraction determined by CMR. | 4-7 days and 6 months following index event | |
| Microvascular obstruction determined by CMR | 4-7 days following index event |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Pernow, Professor | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | S-17176 | Sweden | |||
| Danderyds Hospital |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Quantified ECV (extracellular volume) in left ventricular as myocardium at risk | 4-7 days following index event |
| Myocardial infarct size by CMR expressed as a percentage to the myocardium at risk determined by Bari or modified Approach Score with coronary angiography. | 5-7 days following index event |
| Stockholm |
| Sweden |
| Södersjukhuset | Stockholm | Sweden |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |