Impact of Ranolazine on Myocardial Ischemia Detected by High-Field 3T Cardiovascular Magnetic Resonance (CMR) Imaging and P-31 Spectroscopy
NCT ID: NCT01804543
Last Updated: 2013-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
30 participants
OBSERVATIONAL
2012-06-30
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical, Morphological and Functional Aspects in Myocarditis.
NCT04217876
MRI Evaluation of Chest Pain
NCT00001961
Randomized Investigation of Chest Pain Diagnostic Strategies
NCT01035047
Myocardial Ischemia Detection With a Combined Cardiovascular Magnetic Resonance and Biomarker Protocol
NCT05813210
Role of Endomyocardial Biopsy and Aetiology-based Treatment in Patients With Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management
NCT04521790
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 perfusion imaging and 31P spectroscopy at 3 Tesla.
Abstract:
Despite many advances in cardiovascular medicine for patients with coronary artery disease (CAD), many patients in the United States continue to have the morbidity and mortality associated with chronic stable angina. Ranolazine is a novel late sodium current inhibitor shown to be effective in treating angina in patients with chronic stable coronary artery disease without affecting the blood pressure heart rate product. It has been shown to reduce myocardial energy utilization by enhancing diastolic myocardial relaxation and possibly by increasing myocardial blood flow. While ranolazine has been demonstrated to improve size and severity of stress-induced myocardial perfusion defects, it's direct effect on myocardial metabolism and cellular ischemia has not been tested in humans. We propose using cardiac magnetic resonance imaging (CMRI) and phosphorous-31 magnetic resonance spectroscopy (31P MRS) to evaluate patients with chronic stable angina before and after 4 weeks of a stable dose of ranolazine to detect changes in myocardial blood flow, ventricular function, myocardial scar and metabolic parameters of cellular ischemia.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Angina, Heart Disease
ranolazine 500 mg twice daily for 1 week, then 1000 mg twice daily for 3 weeks
Ranolazine
ranolazine 500 mg, then 1000 mg twice a day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ranolazine
ranolazine 500 mg, then 1000 mg twice a day
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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 Criteria
2. ST-elevation myocardial infarction within 60 days
3. Equivocal myocardial ischemia on non-invasive testing or studies demonstrating reversible perfusion defects complicated by significant attenuation artifacts.
4. Recent PCI within the last 60 days
5. Recent CABG within the last 60 days
6. Inability to sign informed consent
7. Patients who have taken ranolazine within 30 days of screening
8. Patients taking strong CYP3A inhibitors e.g. ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir
9. Patients taking inducers of CYP3A e.g. rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort
10. Patients with liver cirrhosis or liver disease that is Grade B or C by the Child-Pugh Classification
11. Prior allergic reaction or intolerance to ranolazine
12. Patients with a history of inherited or acquired prolonged QT interval
13. Moderate to severe claustrophobia or previous inability to undergo an MRI exam
14. Patients with implanted pacemaker or internal cardiac defibrillator
15. Patients who have a metallic foreign body implants (metal silver in their eye, cochlear implants) or have an aneurysm clip in their brain
16. GFR \< 30 ml/m2
17. Type 2 second degree heart block (Mobitz II) in the absence of functioning permanent pacemaker.
18. Sinus node dysfunction in the absence of functioning permanent pacemaker.
19. Patients taking dipyridamole therapy.
20. Active bronchospasm (active asthma or COPD with active wheezing.
\-
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gilead Sciences
INDUSTRY
Westside Medical Associates of Los Angeles
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
David Gallegos, RN
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Westside Medical Associates of Los Angeles
Beverly Hills, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IN-US- 259-0140
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.