The investigators will test if upfront dosing of Ranolazine can reduce myocardial biomarker release (CK-MB, Troponin) post percutaneous coronary intervention (PCI).
Ranolazine has been demonstrated to decrease angina, ischemia on perfusion imaging, improve diastolic function, and cardiac metabolism. Furthermore it has been associated with reduced cardiac arrhythmias, including non-sustained ventricular tachycardia and atrial fibrillation. It has not been studied as an acute cardioprotective agent in percutaneous coronary intervention (PCI). We hypothesize that upfront administration of Ranolazine could decrease the myocardial injury associated with PCI due to all the factors listed above (i.e. precondition the myocardium). We plan to screen all patients scheduled for an elective coronary angiogram. Those who meet criteria and consent will be randomized to either receive Ranolazine or placebo twice a day for 3 days leading up to the PCI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
6
Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI
Drug: Placebo Oral dose twice per day for 3 days leading up to PCI
Kettering Medical Center
Kettering, Ohio, United States
Troponin
Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first
Time frame: 8-10 hrs post PCI
CK-MB
CK-MB labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first
Time frame: 8-10 hrs post PCI
TIMI Flow Rate (Grade)
This TIMI classification was developed by the TIMI (Thrombolysis In Myocardial Infarction) study group to semiquantitatively assess coronary artery perfusion beyond point of occlusion on coronary angiography.\* TIMI Grade \[Description\] TIMI 0 - no perfusion \[no antegrade flow beyond the point of occlusion\] TIMI 1 - penetration without perfusion \[faint antegrade coronary flow beyond the occlusion with incomplete filling of the distal coronary bed\] TIMI 2 - partial perfusion \[delayed or sluggish antegrade flow with complete filling of the distal territory\] TIMI 3 - complete perfusion \[normal flow with complete filling of the distal territory\] \*(see http://radclass.mudr.org/content/timi-grade-flow-grading-coronary-blood-flow-during-coronary-angiography) TIMI 0 is the least favorable grade. TIMI 3 is the most favorable grade.
Time frame: TIMI Flow Rate (Grade) is assessed immediately after an interventional reperfusion attempt during a PCI (Percutaneous Coronary Intervention) procedure.
Incidence of Atrial Fibrillation, Ventricular Tachycardia, or Ventricular Fibrillation in Coronary Cath Lab
Abnormal heart activity
Time frame: During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire
Incidence of Non-sustained Ventricular Tachycardia or Atrial Fibrillation Post PCI
Time frame: Following completion of PCI through hospital discharge
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Left Ventricular End Diastolic Pressure (LVEDP)
Time frame: During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire
Death, Myocardial Infarction (Biomarker Greater Than 2x Normal), CHF, Cardiac Arrest
Time frame: At discharge or within 1 days, whichever comes first
Death, MI, Revascularization, CHF
Time frame: 1-4 weeks post PCI
Successful PCI
For the purposes of this study, a successful PCI is considered one where no additional coronary interventions were required within 24 hours after the initial PCI.
Time frame: At discharge or within 1 days, whichever comes first