Statin and Atheroma Vulnerability Evaluation

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of statin therapy on the modification of atherosclerotic plaque composition and vulnerability in non-intervened coronary arteries with mild to moderate stenosis using VH-IVUS and OCT.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seung-Jung Park
• Collaborator: CardioVascular Research Foundation, Korea
• Treatments: Calcium; Calcium, Dietary; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

1. Male or female at least 18 years of age inclusive.

2. Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia who will undergo either planned coronary angiography, or percutaneous coronary intervention

3. Non-culprit de novo lesion in a native coronary artery with at least one deferred coronary lesion with 1) visually-estimated angiographic % diameter stenosis 20-50% or 2) % diameter stenosis >50% without any evidence of inducible ischemia (FFR≥0.8 or negative perfusion on thiallium scan or negative treadmill test). Index lesion should have at least 1 fibroatheroma or TCFA.

4. The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site

Exclusion Criteria:

1. Planned cardiac surgery (e.g., CABG, valve repair or replacement, or aneurysmectomy) or planned major non-cardiac surgery within the study period

2. Stroke or resuscitated sudden death in the past 6 months

3. Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible)

4. Untreated hyperthyroidism, or hypothyroidism with TSH levels more than 1.5 times upper limit of normal

5. A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer

6. Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study

7. Evidence of congestive heart failure, or left ventricular ejection fraction < 40%

8. Significant renal disease manifested by serum creatinine > 2.0mg/dL, or creatinine clearance of < 40 ml/min (by Cockcroft-Gault method)

9. Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal)

10. History of myopathy or elevated creatine kinase (CK) > 3 times upper normal limit at screening

11. History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s)

12. Unwillingness or inability to comply with the procedures described in this protocol

13. History of any arterial bypass or angioplastic intervention involving the target vessel

14. The luminal narrowing in the target vessel or in the left main coronary artery >50% by visual inspection of angiogram

15. Luminal diameter of the target vessel < 2.5mm by visual inspection of coronary angiogram

16. Presence of thrombus or complex plaque morphology in the target vessel that suggests a high likelihood of distal embolism

17. Severe tortuosity of the target vessel or any other anatomical reasons that the investigator deems inappropriate for IVUS procedures