Status:
UNKNOWN
Impact of Ranolazine on Myocardial Ischemia Detected by High-Field 3T Cardiovascular Magnetic Resonance (CMR) Imaging and P-31 Spectroscopy
Lead Sponsor:
Westside Medical Associates of Los Angeles
Collaborating Sponsors:
Gilead Sciences
Conditions:
Angina
Heart Disease
Eligibility:
All Genders
18+ years
Brief Summary
Evaluation of use of ranolazine in patients with stable heart pain with cardiac magnetic resonance imaging (CMRI) and phosphorous-31 magnetic resonance spectroscopy (31P MRS). Subsequent testing using...
Detailed Description
Specific Aim: To determine in patients with stable coronary artery disease with documented inducible ischemia, if treatment with ranolazine leads to reduced intracellular ischemia as detected by CMR ...
Eligibility Criteria
Inclusion
- Age \>18 years of age with stable angina pectoris or an anginal equivalent symptom (e.g. atypical chest discomfort, dyspnea, easy fatigue) AND
- Mild, moderate or severe myocardial ischemia detected on nuclear perfusion imaging (exercise or pharmacologic SPECT or Rubidium PET), exercise stress echocardiography or stress cardiac MRI OR Documentation of obstructive coronary artery with at least one major coronary artery (left anterior descending, circumflex or right coronary artery) of at least 70% by either conventional or CT coronary angiography.
Exclusion
- Acute coronary syndrome including unstable angina or non ST elevation myocardial infarction within the last 60 days
- ST-elevation myocardial infarction within 60 days
- Equivocal myocardial ischemia on non-invasive testing or studies demonstrating reversible perfusion defects complicated by significant attenuation artifacts.
- Recent PCI within the last 60 days
- Recent CABG within the last 60 days
- Inability to sign informed consent
- Patients who have taken ranolazine within 30 days of screening
- Patients taking strong CYP3A inhibitors e.g. ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir
- Patients taking inducers of CYP3A e.g. rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort
- Patients with liver cirrhosis or liver disease that is Grade B or C by the Child-Pugh Classification
- Prior allergic reaction or intolerance to ranolazine
- Patients with a history of inherited or acquired prolonged QT interval
- Moderate to severe claustrophobia or previous inability to undergo an MRI exam
- Patients with implanted pacemaker or internal cardiac defibrillator
- Patients who have a metallic foreign body implants (metal silver in their eye, cochlear implants) or have an aneurysm clip in their brain
- GFR \< 30 ml/m2
- Type 2 second degree heart block (Mobitz II) in the absence of functioning permanent pacemaker.
- Sinus node dysfunction in the absence of functioning permanent pacemaker.
- Patients taking dipyridamole therapy.
- Active bronchospasm (active asthma or COPD with active wheezing.
- \-
Key Trial Info
Start Date :
June 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01804543
Start Date
June 1 2012
End Date
December 1 2014
Last Update
March 5 2013
Active Locations (1)
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1
Westside Medical Associates of Los Angeles
Beverly Hills, California, United States, 90211