Perioperative myocardial ischaemia and cytokine response in patients undergoing high-risk surgery: the influence of fluvastati

Completed

• Conditions: Surgery; Vascular surgery; Perioperative myocardial ischaemia

• Registration Number: ISRCTN83738615
• Lead Sponsor: Erasmus Medical Centre (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-07
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Aged greater than 40 years
2. Scheduled for elective noncardiac surgery
3. Risk score for perioperative cardiovascular death greater than or equal to 51 points
5. Written informed consent

Exclusion Criteria

1. Currently on statin therapy
2. Contraindication for statin therapy
3. Scheduled for surgery which interferes with continuous 12-lead Electrocardiogram (ECG) recording, such as thoracic and upper abdominal surgery
4. Unstable coronary disease
5. Undergoing emergency surgery
6. Patients with extensive stress-induced ischaemia during dobutamine stress test
7. Creatine Kinase (CK) at baseline greater than 10 x Upper Limit of Normal (ULN)
8. Previous participation in the fluvastatin-study
9. Reoperation within 30 days of an initial surgical procedure
10. Participation in another clinical trial within the last 30 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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