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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

Tracking Information
First Submitted Date  ICMJE March 12, 2013
First Posted Date  ICMJE March 14, 2013
Last Update Posted Date March 14, 2013
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
Postoperative troponin [ Time Frame: 3 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pathophysiology and Prevention of Perioperative Myocardial Injury: A Prospective Randomized Controlled Trial
Official Title  ICMJE Pathophysiology and Prevention of Perioperative Myocardial Injury: A Prospective Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Coronary Artery Disease,
Intervention  ICMJE Drug: Ranolazine
Ranolazine versus placebo
Other Name: Ranexa
Study Arms  ICMJE
  • Experimental: Ranolazine treatment
    Ranolazine 500-1000mg bid
    Intervention: Drug: Ranolazine
  • Placebo Comparator: Placebo
    Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 13, 2013)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01810796
Other Study ID Numbers  ICMJE HRanTrop
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Giora Landesberg, Hadassah Medical Organization
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Giora Landesberg, MD Hadassah Medical Organization
PRS Account Hadassah Medical Organization
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP