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Pathophysiology and Prevention of Perioperative Myocardial Injury: A Prospective Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01810796
Recruitment Status : Unknown
Verified March 2013 by Giora Landesberg, Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : March 14, 2013
Last Update Posted : March 14, 2013
Information provided by (Responsible Party):
Giora Landesberg, Hadassah Medical Organization

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 rate, prevents postoperative myocardial injury.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease, Drug: Ranolazine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pathophysiology and Prevention of Perioperative Myocardial Injury: A Prospective Randomized Controlled Trial
Study Start Date : December 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ranolazine

Arm Intervention/treatment
Experimental: Ranolazine treatment
Ranolazine 500-1000mg bid
Drug: Ranolazine
Ranolazine versus placebo
Other Name: Ranexa

Placebo Comparator: Placebo

Primary Outcome Measures :
  1. Postoperative troponin [ Time Frame: 3 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01810796

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Contact: Giora Landesberg, Assoc. Prof. 97226777269

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Hadassah - Hebrew University Medical Center
Jerusalem, Israel, 91120
Contact: Giora Landesberg, Assoc. Prof.    97226777269   
Principal Investigator: Giora Landesberg, Assoc. Prof.         
Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: Giora Landesberg, MD Hadassah Medical Organization
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Responsible Party: Giora Landesberg, Associate Profesor, Hadassah Medical Organization Identifier: NCT01810796    
Other Study ID Numbers: HRanTrop
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action