Microcirculation In Acute Coronary Syndromes (MICROS)
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|ClinicalTrials.gov Identifier: NCT01382472|
Recruitment Status : Unknown
Verified August 2016 by Helse Stavanger HF.
Recruitment status was: Recruiting
First Posted : June 27, 2011
Last Update Posted : August 25, 2016
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:
- reduces area of myocardial infarction, reduces volumes and improves remodelling as assessed by MRI at 2 days and at 2 months
- improves microcirculation (Decreased number of patients with MO) as assessed by first pass time estimated with MRI 2 days
- have impact on coronary blood flow as assessed by intravascular registrations and TIMI frame count immediately after PCI
- reduce levels of CK-MB and TnT measured as area under the curve during the hospital stay at improves neurohumoral profile assessed by Heart Rate Variability (HRV) and neurohormones at discharge and at 2 months follow-up
- improves endothelial function assessed by flow mediated vasodilatation at discharge
- alters Peak VO2 at 1 and 6 month
- reduce levels of CRP and pro-inflammatory cytokines during index hospitalization and at follow-up alters collagen turnover
|Condition or disease||Intervention/treatment||Phase|
|ST Elevation (STEMI) Myocardial Infarction||Drug: Rosuvastatin Drug: Simvastatin||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||MICROS-Pilot Study Microcirculation In Acute Coronary Syndromes; Effect of Pre-treatment of High Dose Rosuvastatin on Coronary Microcirculation in Primary PCI|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
40 mg rosuvastatin pre PCI and daily during hospital stay
40 mg per operative in PPCI, the 40 daily during hospital stay
Other Name: Crestor-AstraZeneca
Historical data (KOMPIS)
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.
No statin acutely. Simvastatin 20 mg from day 2.
- infarct size [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01382472
|Stavanger University Hospital||Recruiting|
|Stavanger, Norway, 4068|
|Contact: Alf Inge Larsen, MD, PhD +4751513201 firstname.lastname@example.org|
|Principal Investigator: Noreen Butt, MD|
|University Hospital of North Norway||Recruiting|
|Tromsø, Norway, NO-9038|
|Contact: Terje Steigen, MD, PhD +4791507766 email@example.com|
|Principal Investigator: Terje Steigen, MD PhD|
|St. Olavs Hospital||Not yet recruiting|
|Trondheim, Norway, NO-7006|
|Contact: Rune Wiseth, MD, PhD +4772573000 firstname.lastname@example.org|
|Principal Investigator: Rune Wiseth, MD, PhD|
|Study Chair:||Alf Inge Larsen, MD, PhD||Helse Stavanger HF|
|Principal Investigator:||Noreen Butt, MD||Helse Stavanger HF|
|Principal Investigator:||Terje Steigen, MD, PhD||University Hospital of North Norway|
|Principal Investigator:||Rune Wiseth, MD, PhD||St. Olavs Hospital|