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

Coronary Artery Disease, Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01810796
• Other study ID #: HRanTrop
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 12, 2013
• Last updated: March 13, 2013
• Start date: December 2013
• Est. completion date: December 2017

Study information

• Verified date: March 2013
• Source: Hadassah Medical Organization
• Contact: Giora Landesberg, Assoc. Prof.
• Phone: 97226777269
• Email: gio[@]cc.huji.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease,
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Ranolazine
Ranolazine versus placebo

Locations

Country	Name	City	State
Israel	Hadassah - Hebrew University Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative troponin		3 days	Yes