Suspended

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Ranolazine

Drug
Who is being recruted

Arterial Occlusive Diseases+5

+ Arteriosclerosis

+ Cardiovascular Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 3
Interventional
Study Start: December 2013
See protocol details

Summary

Principal SponsorHadassah Medical Organization
Study ContactGiora Landesberg, Assoc. Prof.More contacts
Last updated: March 14, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01810796
Principal SponsorHadassah Medical Organization
Study ContactGiora Landesberg, Assoc. Prof.More contacts
Last updated: March 14, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesCoronary DiseaseHeart DiseasesVascular DiseasesMyocardial IschemiaCoronary Artery Disease

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Ranolazine 500-1000mg bid

Group II

Placebo
Placebo

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Hadassah - Hebrew University Medical Center

Jerusalem, IsraelOpen Hadassah - Hebrew University Medical Center in Google Maps
SuspendedOne Study Center