Impact of Ranolazine on Myocardial Ischemia Detected by High-Field 3T Cardiovascular Magnetic Resonance (CMR) Imaging and P-31 Spectroscopy
1 other identifier
observational
30
1 country
1
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 these modalities will show improved oxygen to the heart muscle.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 3, 2012
CompletedFirst Posted
Study publicly available on registry
March 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMarch 5, 2013
March 1, 2013
1.5 years
August 3, 2012
March 4, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
parameters of cellular ischemia by 31P MRS
post 4 weeks of therapy with ranolazine
Secondary Outcomes (1)
myocardial perfusion indices
post 4 weeks of therapy with ranolazine
Study Arms (1)
Angina, Heart Disease
ranolazine 500 mg twice daily for 1 week, then 1000 mg twice daily for 3 weeks
Interventions
Eligibility Criteria
Subject with chest pain or equivalence (atypical chest pain, shortness of breath, or fatigue)
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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Westside Medical Associates of Los Angeleslead
- Gilead Sciencescollaborator
Study Sites (1)
Westside Medical Associates of Los Angeles
Beverly Hills, California, 90211, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 3, 2012
First Posted
March 5, 2013
Study Start
June 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2014
Last Updated
March 5, 2013
Record last verified: 2013-03