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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 rate, prevents postoperative myocardial injury.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranolazine treatment | Experimental | Ranolazine 500-1000mg bid |
|
| Placebo | Placebo Comparator | Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranolazine | Drug | Ranolazine versus placebo |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative troponin | 3 days |
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Inclusion Criteria:
- 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 Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giora Landesberg, Assoc. Prof. | Contact | 97226777269 | gio@cc.huji.ac.il |
| Name | Affiliation | Role |
|---|---|---|
| Giora Landesberg, MD | Hadassah Medical Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah - Hebrew University Medical Center | Jerusalem | 91120 | Israel |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069458 | Ranolazine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |