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

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ClinicalTrials.gov 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
Sponsor:
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.

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
U.S. FDA Resources

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



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


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

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 ClinicalTrials.gov identifier (NCT number): NCT01810796


Contacts
Contact: Giora Landesberg, Assoc. Prof. 97226777269 gio@cc.huji.ac.il

Locations
Israel
Hadassah - Hebrew University Medical Center Not yet recruiting
Jerusalem, Israel, 91120
Contact: Giora Landesberg, Assoc. Prof.    97226777269    gio@cc.huji.ac.il   
Principal Investigator: Giora Landesberg, Assoc. Prof.         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Giora Landesberg, MD Hadassah Medical Organization

Responsible Party: Giora Landesberg, Associate Profesor, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01810796     History of Changes
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:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ranolazine
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action