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

This study is not yet open for participant recruitment.
Verified March 2013 by Giora Landesberg, Hadassah Medical Organization
Sponsor:
ClinicalTrials.gov Identifier:
NCT01810796
First Posted: March 14, 2013
Last Update Posted: March 14, 2013
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Giora Landesberg, Hadassah Medical Organization
  Purpose
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 Intervention Phase
Coronary Artery Disease, Drug: Ranolazine Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Giora Landesberg, Hadassah Medical Organization:

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

Estimated Enrollment: 300
Study Start Date: December 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranolazine treatment
Ranolazine 500-1000mg bid
Drug: Ranolazine
Ranolazine versus placebo
Other Name: Ranexa
Placebo Comparator: Placebo
Placebo

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.
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Responsible Party: Giora Landesberg, Associate Profesor, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01810796     History of Changes
Other Study ID Numbers: HRanTrop
First Submitted: March 12, 2013
First Posted: March 14, 2013
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