statin
Conditions
Interventions
Patients will come for an outpatient visit (= screening) approximately 30 days (= mean) prior to surgery. Informed consent will then be signed and in- and exclusion criteria will be checked. If the pa
Sponsors
Erasmus MC, Rotterdam, the Netherlands.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age > 40 years; 2. Scheduled for elective noncardiac surgery; 3. Risk score for perioperative; 4. Cardiovascular death „d51 points; 5. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Currently on statin therapy; 2. Contraindication for statin therapy; 3. Scheduled for surgery which interferes with continuous 12-lead ECG recording, such as thoracic and upper abdominal surgery; 4. Unstable coronary disease; 5. Undergoing emergency surgery; 6. Patients with extensive stress-induced ischemia during dobutamine stress test; 7. CK at baseline > 10x 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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; 2. Composite of cardiovascular death and myocardial infarction within 30 days after surgery. | — |
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactD. Poldermans
Erasmus MC Department of Anesthesiology
Outcome results
None listed