Back to resultsPathophysiology and Prevention of Perioperative Myocardial Injury: A Prospective Randomized Controlled Trial
Primary Purpose
Coronary Artery Disease,
Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Ranolazine
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease,
Eligibility 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
Sites / Locations
- Hadassah - Hebrew University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ranolazine treatment
Placebo
Arm Description
Ranolazine 500-1000mg bid
Placebo
Outcomes
Primary Outcome Measures
Postoperative troponin
Secondary Outcome Measures
Full Information
NCT ID
NCT01810796
First Posted
March 12, 2013
Last Updated
March 13, 2013
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01810796
Brief Title
Pathophysiology and Prevention of Perioperative Myocardial Injury: A Prospective Randomized Controlled Trial
Official Title
Pathophysiology and Prevention of Perioperative Myocardial Injury: A Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease,
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ranolazine treatment
Arm Type
Experimental
Arm Description
Ranolazine 500-1000mg bid
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Ranolazine
Other Intervention Name(s)
Ranexa
Intervention Description
Ranolazine versus placebo
Primary Outcome Measure Information:
Title
Postoperative troponin
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giora Landesberg, Assoc. Prof.
Phone
97226777269
Email
gio@cc.huji.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giora Landesberg, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah - Hebrew University Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giora Landesberg, Assoc. Prof.
Phone
97226777269
Email
gio@cc.huji.ac.il
First Name & Middle Initial & Last Name & Degree
Giora Landesberg, Assoc. Prof.
12. IPD Sharing Statement
Learn more about this trial
Pathophysiology and Prevention of Perioperative Myocardial Injury: A Prospective Randomized Controlled Trial
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