Pathophysiology and Prevention of Perioperative Myocardial Injury: A Prospective Randomized Controlled Trial
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 coronary-artery-disease
Started Dec 2013
Typical duration for phase_3 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2013
CompletedFirst Posted
Study publicly available on registry
March 14, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 14, 2013
March 1, 2013
3 years
March 12, 2013
March 13, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative troponin
3 days
Study Arms (2)
Ranolazine treatment
EXPERIMENTALRanolazine 500-1000mg bid
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- \- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah - Hebrew University Medical Center
Jerusalem, 91120, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giora Landesberg, MD
Hadassah Medical Organization
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Profesor
Study Record Dates
First Submitted
March 12, 2013
First Posted
March 14, 2013
Study Start
December 1, 2013
Primary Completion
December 1, 2016
Study Completion
December 1, 2017
Last Updated
March 14, 2013
Record last verified: 2013-03