Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01382472 |
| Other study ID # |
MICROS |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
September 2011 |
| Est. completion date |
December 2016 |
Study information
| Verified date |
August 2016 |
| Source |
Helse Stavanger HF |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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:
1. reduces area of myocardial infarction, reduces volumes and improves remodelling as
assessed by MRI at 2 days and at 2 months
2. improves microcirculation (Decreased number of patients with MO) as assessed by first
pass time estimated with MRI 2 days
3. have impact on coronary blood flow as assessed by intravascular registrations and TIMI
frame count immediately after PCI
4. 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
5. improves endothelial function assessed by flow mediated vasodilatation at discharge
6. alters Peak VO2 at 1 and 6 month
7. reduce levels of CRP and pro-inflammatory cytokines during index hospitalization and at
follow-up alters collagen turnover
Description:
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
