NCT03257683

RANOLAZINE STUDY: Speckle Tracking Derived Myocardial Strain

RANOLAZINE STUDY: The Effect of Ranolazine on Speckle Tracking Derived Myocardial Strain in Regions of Non-Revascularizable Ischemic Myocardium

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Saint Thomas Health · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect data to determine if the medication, Ranolazine, effects heart muscle function in patients who have areas of non-revascularizable heart muscle.

Detailed description

Many cardiac patients with severe coronary artery disease have areas of ischemic LV myocardium that cannot be revascularized (Non-R). The investigators propose to identify such patients via retrospective case review of CMRI data, as well as identify the exact regions which specify Non-R coronary anatomy. This selected study group will have a specific echocardiographic imaging protocol performed, which includes the known ischemic regions. All segments will be collected and analyzed as a pre-therapeutic baseline using specialized STE software to derive strain values. Following eight (8) weeks of ranolazine therapy, each subject will be re-interrogated with the same echocardiographic imaging protocol and have identical measurements of regional strain performed. Ranolazine will be added to the patients' usual medical therapy. Each patient will serve as their own control, from baseline to post therapeutic state. It is the hypothesis of the investigators, that additional therapeutic dosing of ranolazine will improve regional and perhaps global myocardial function. Improvement in LV mechanical function (regional and global) will be quantitated and objectively elucidated by STE derived myocardial strain as described further in this document.

Conditions

• Severe Coronary Artery Disease
• Ischaemic Myocardial Dysfunction

Interventions

Type	Name	Description
DRUG	Ranolazine	Study group will receive additional therapeutic dosing of drug.

Timeline

• Start date: 2017-04-14
• Primary completion: 2017-11-16
• Completion: 2018-02-16
• First posted: 2017-08-22
• Last updated: 2018-04-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study