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| Name | Class |
|---|---|
| Helse Vest | OTHER |
| University Hospital of North Norway | OTHER |
| St. Olavs Hospital | OTHER |
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In this mechanistic pilot study in 40 patients the investigators will compare the findings in patients treated with very early high dose statin therapy with historic controls from the KOMPIS study published in EHJ 200925. The investigators want to assess if early high dose statin therapy in patients treated with primary PCI:
Impairment of the myocardial microcirculation in the setting of AMI is multifactorial in etiology. This may be due to vasoactive factors including endothelin-1, which is a potent vasoconstricting peptide and increasingly expressed in the active plaque . Oxidative stress and ischaemia per se may also reduce the bioavailability of nitric oxide, further contributing to the dysfunction of the myocardial microcirculation.
Statins have been shown to benefit ACS patients in that they are believed to decrease reperfusion injury after an ischemic event, promote plaque stabilization, and reduce inflammation in ACS patients. In patients admitted with acute coronary syndrome (ACS), treatment with statins <24 hours of presentation was associated with lower incidences of death, stroke, reinfarction, heart failure, and pulmonary edema compared with delayed administration .
40 statin naive patients admitted with STEMI will receive high dose statin Rosuvastatin 40 mg pre/per primary PCI and continue this treatment during the hospital stay. The high dose of rosuvastatin is chosen to achieve high plasma concentration as early as possible for per conditioning of the myocardium at risk. At discharge they will be switched to standard dose statin.
Myocardial infarction will be assessed with Contrast enhanced cardiac magnetic resonance at 2 days and at 2 months. Microvascular obstruction (MO) may be assessed by first- pass perfusion (FPP) and delayed hyper enhancement (DHE) MO is defined as regional hypoperfusion on first-pass perfusion as previously described . The investigators have recently demonstrated that MO as verified by CMR following MI may allow early identification of patients with a high risk of LV remodeling likely to benefit from pharmacological therapy .
Blood tests for assessment of collagen turnover, neurohumoral activation and inflammation will be drawn daily during hospital stay.
The Results will be compared with the findings of statin naive patients from tha KOMPIS trial who were not treated with high dose pre and per operative statins
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin | Experimental | 40 mg rosuvastatin pre PCI and daily during hospital stay |
|
| Historical data (KOMPIS) | Other | Patients from the KOMPIS trial (n=44) will be used as historical controls. They received no statins omn the first day. Low dose simvastatin during hospital stay. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | 40 mg per operative in PPCI, the 40 daily during hospital stay |
|
| Measure | Description | Time Frame |
|---|---|---|
| infarct size | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alf Inge Larsen, MD, PhD | Helse Stavanger HF | Study Chair |
| Noreen Butt, MD | Helse Stavanger HF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stavanger University Hospital | Stavanger | 4068 | Norway | |||
| University Hospital of North Norway |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Simvastatin | Drug | No statin acutely. Simvastatin 20 mg from day 2. |
|
| Tromsø |
| NO-9038 |
| Norway |
| St. Olavs Hospital | Trondheim | NO-7006 | Norway |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |