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 Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Giora Landesberg, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01810796
First received: March 12, 2013
Last updated: March 13, 2013
Last verified: March 2013
  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: Double Blind (Subject, Caregiver, 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 Hadassah Medical Organization:

Primary Outcome Measures:
  • Postoperative troponin [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Giora Landesberg, Associate Profesor, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01810796     History of Changes
Other Study ID Numbers: HRanTrop
Study First Received: March 12, 2013
Last Updated: March 13, 2013
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Wounds and Injuries
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014