Impact of Ranolazine on Myocardial Ischemia Detected by High-Field 3T Cardiovascular Magnetic Resonance (CMR) Imaging and P-31 Spectroscopy

Status unconfirmed

Conditions studied: Angina, Heart Disease

In brief

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 these modalities will show improved oxygen to the heart muscle.

Key facts

Study ID

NCT01804543

Run by

Westside Medical Associates of Los Angeles

People needed

30

Starts

2012-06-01

Expected to finish

2014-12-01

Last updated by the study team

2013-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Westside Medical Associates of Los Angeles — Beverly Hills, California, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.