Ignite Creation Date:
2024-05-05 @ 11:39 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01382472
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2011-06-20
Brief Title:
Microcirculation In Acute Coronary Syndromes
Sponsor:
Helse Stavanger HF
Organization:
Helse Stavanger HF
Study Overview
Official Title:
MICROS-Pilot Study Microcirculation In Acute Coronary Syndromes Effect of Pre-treatment of High Dose Rosuvastatin on Coronary Microcirculation in Primary PCI
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MICROS
Brief 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
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
Detailed 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 preper 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
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 preper 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None