Myocardial Infarction [C14.907.585.500]
Conditions
Keywords
Index of microcirculatory resistance, Fractional Flow Reserve
Brief summary
The aim of this study was to measure the effect of low- and high-dose lipid-lowering treatment with rosuvastatin on the coronary physiology parameters.
Interventions
DRUGLow-dose Rosuvastatin
Rosuvastatin 5mg/day for one year
Rosuvastatin 40mg/day for one year
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 81 Years
Healthy volunteers
No
Inclusion criteria
1. ST-segment elevation myocardial infarction 2. no prior treatment with statins and 3. a non significant lesion in one of the two non-culprit coronary arteries
Exclusion criteria
1. age below 18 or above 81 years, 2. unconscious patients, 3. serum creatinine \> 176μmol/L, 4. hypothyroidism ((TSH \> 1.5 x ULN (upper limit of normal)), 5. current liver disease (ALAT \> 2 x ULN), 6. unexplained creatine kinase \> 3 x ULN, 7. alcohol or drug abuse within the last five years, 8. prior myopathy or serious hypersensitivity reaction caused by statins, 9. women with childbearing potential who were not using chemical or mechanical contraception, 10. pregnant or breastfeeding women, 11. history of malignancy unless a disease-free period of more than five years was present, 12. patients with abnormal lung function test (LFT), 13. participation in another investigational drug study less than four weeks before enrolment in the present study, 14. treatment with cyclosporine or fibrates
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint was the change from baseline in Index of microcirculatory resistance(IMR). | One year |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints were the changes from baseline in Fractional Flow Reserve (FFR) and lipid values. | One year |
Countries
Denmark
Outcome results
None listed