Perioperative myocardial ischemia and cytokine response in patients undergoing high-risk surgery; the influence of fluvastatin.

Completed

• Conditions: statin; perioperative; vascular surgery; inflammation

• Registration Number: NL-OMON27929
• Lead Sponsor: Erasmus MC, Rotterdam, the Netherlands.

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

1. Age > 40 years;

2. Scheduled for elective noncardiac surgery;

Exclusion Criteria

1. Currently on statin therapy;

2. Contraindication for statin therapy;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the occurrence of myocardial ischemia recorded during a 96-hour period using a 12-lead Rozing recorder. Ischemia is divided into pre, peri, and post-operative periods. The severity of ischemia in each period is scored as 'ischemic burden', reflecting the duration (minutes) and severity (ST-segment change from baseline) of ischemia.

Secondary Outcome Measures

Name	Time	Method
1. Perioperative cytokine response. At screening, before the induction of anaesthesia, and after surgery cytokines are measured at 6, 24 hours after surgery, at 48, 72, and 96 hours after surgery; and 4, 5, 6, and 7 days after surgery;<br /><br>2. Composite of cardiovascular death and myocardial infarction within 30 days after surgery.<br>