Statin Therapy in Ischemia-Reperfusion Injury during coronary artery bypass grafting.

Phase 4

• Conditions: Post CABG ischemia reperfusion injury (IRI); Cardiovascular - Coronary heart disease; Surgery - Other surgery

• Registration Number: ACTRN12613000031763
• Lead Sponsor: South Australian Health and Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Adult patients who are scheduled to undergo elective on-pump CABG with or without aortic valve replacement.
For patients on statins pre-CABG, statin dose must be unchanged for 30 days pre-CABG.

Exclusion Criteria

Standard CMR contra-indications
Known intolerance to statins
Renal (eGFR <45mls/min) and hepatic impairment
Emergency CABG
Mitral or tricuspid valve repair or replacement
Off-pump CABG
Patients who are Filipino, Chinese, Japanese, Korean or Vietnamese
Patients on cyclosporine, gemfibrozil or fisidic acid
Patients who are already on rosuvastatin or atorvastatin 80 mgs pre-CABG
Re-do surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Myocardial Infarct (MI) size as assessed by CMR late gadolinium-enhancement[At Baseline (up to 30 days before CABG) and then 5-10 days post CABG surgery]

Secondary Outcome Measures

Name	Time	Method
Biochemical markers of myocardial injury will be assessed by calculating the total area under the curve of the cardiac enzyme levels (CK, CKMB and Hs Troponin T) taken over an 120 hour period.[Baseline(0 Hours) pre CABG, 6, 12, 24, 48, 72 and 120 hours]