Status:
UNKNOWN
Pathophysiology and Prevention of Perioperative Myocardial Injury: A Prospective Randomized Controlled Trial
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Coronary Artery Disease,
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Working hypothesis and aims: 1) To explore the pathophysiology of postoperative troponin elevations and 2) whether ranolazine, a new anti-ischemic drug that has no effect on blood pressure or heart ra...
Detailed Description
High-risk patients undergoing non cardiac surgery will be randomized to receive either Ranolazine or placebo perioperatively and troponin will be measured on the first 3 days after surgery.
Eligibility Criteria
Inclusion
- \- All patients age 18 and above, undergoing major surgery that require at least 24 hours (overnight) stay in the post anesthesia care unit (PACU) or intensive care unit (ICU), and who either have known history of CAD or at least 3 of the following Revised Cardiac Risk Index (RCRI) criteria29F17: 1) high-risk type of surgery, 2) history of ischemic heart disease, 3) history of congestive heart failure, 4) history of cerebrovascular disease, 5) diabetes mellitus, 6) renal failure (creatinine \> 2mg/ml).
Exclusion
- Pregnancy, LV ejection fraction ≤35%, patients with severe valvular disease, patients with poor echocardiographic images, patients who cannot swallow the pill after surgery, refusal to participate
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01810796
Start Date
December 1 2013
End Date
December 1 2017
Last Update
March 14 2013
Active Locations (1)
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1
Hadassah - Hebrew University Medical Center
Jerusalem, Israel, 91120