Coronary artery disease
Conditions
Interventions
1. Off-line IVUS-VH of one ‘study vessel’ at baseline and 52 weeks follow-up
2. LipiScan examination of the ‘study-vessel’ at baseline and 52 weeks follow-up
3. Blood samples for lipid profile at baseline and 52 weeks follow-up (hs-CRP, genetic, SNP, RNA, proteomic and lipidomic analysis as well as cellular and functional analysis will be obtained)
4. Rosuvastatin 40 mg (uptitrated within 30 days) for 12 months.
Sponsors
Erasmus Medical center (Thoraxcenter)
Eligibility
Inclusion criteria
Inclusion criteria: 1. More than 18 years old; 2. Written informed consent; 3. Patients with stable angina pectoris or unstable angina pectoris (Braunwald Class I-III, B-C) or patients with documented silent ischemia or patients with an acute myocardial infarction; 4. Patients eligible for coronary revascularisation in the native coronary artery/arteries or candidate for invasive coronary diagnostic procedure; 5. Willing to follow all study procedures including adherence to lipid-lowering diet, study visits and compliance with study treatment regimen.
Exclusion criteria
Exclusion criteria: 1. Braunwald class IA, IIA, IIIA (unstable angina caused by non-cardiac illness); 2. Women who are pregnant or women of childbearing potential who do not use adequate contraception; 3. Known allergies to aspirin, clopidogrel bisulfate (Plavix ®), Ticlopdine (Ticlid ®) heparin, stainless steel, copper or a sensitivity to contrast media which cannot be adequately pre-medicated; 4. Previous participation in this study; 5. Life expectancy of less than one year or factors making clinical and/or angiographic follow-up difficult; 6. Planned coronary bypass surgery; 7. Planned major non-cardiac surgery; 8. The subject has a history of bleeding diathesis or coagulopathy; 9. The subject suffered disabling stroke within the past year; 10. Known major hematologic, neoplastic, metabolic, gastrointestinal or endocrine dysfunction which, in the judgment of the Investigator, may affect the patient’s ability to complete the study; 11. History of malignancy, except in patients who have been disease-free >5 years or whose only malignancy has been basal or squamous cell skin carcinoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this clinical trial is to determine whether 40 mg rosuvastatin during 12 months decreases necrotic core as assessed by IVUS - VH at 52 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine whether rosuvastatin reduces lipid core as assessed by LipiScan at 52 weeks. | — |
Contacts
Public ContactP.W.J.C. Serruys
Thoraxcenter, Erasmus Medical Center
Outcome results
None listed