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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Westside Medical Associates of Los Angeles
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
David Gallegos, RN, Westside Medical Associates of Los Angeles
ClinicalTrials.gov Identifier:
NCT01804543
First received: August 3, 2012
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Angina
Heart Disease
Drug: Ranolazine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Ranolazine on Myocardial Ischemia Detected by High-Field 3T Cardiovascular Magnetic Resonance (CMR) Imaging and P-31 Spectroscopy

Resource links provided by NLM:


Further study details as provided by Westside Medical Associates of Los Angeles:

Primary Outcome Measures:
  • parameters of cellular ischemia by 31P MRS [ Time Frame: post 4 weeks of therapy with ranolazine ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • myocardial perfusion indices [ Time Frame: post 4 weeks of therapy with ranolazine ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Angina, Heart Disease
ranolazine 500 mg twice daily for 1 week, then 1000 mg twice daily for 3 weeks
Drug: Ranolazine
ranolazine 500 mg, then 1000 mg twice a day
Other Name: Ranexa

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subject with chest pain or equivalence (atypical chest pain, shortness of breath, or fatigue)

Criteria

Inclusion Criteria:

  1. Age >18 years of age with stable angina pectoris or an anginal equivalent symptom (e.g. atypical chest discomfort, dyspnea, easy fatigue) AND
  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:

  1. Acute coronary syndrome including unstable angina or non ST elevation myocardial infarction within the last 60 days
  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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01804543

Contacts
Contact: David Gallegos, RN (310) 289-9955 david@westsidecardio.com

Locations
United States, California
Westside Medical Associates of Los Angeles Recruiting
Beverly Hills, California, United States, 90211
Contact: David Gallegos, RN    310-289-9955    david@westsidecardio.com   
Principal Investigator: Gabriel Vorobiof, MD         
Sub-Investigator: Norman Lepor, MD         
Sub-Investigator: Hooman Madyoon, MD         
Sub-Investigator: Gerald Pohost, MD         
Sub-Investigator: Hee-won Kim, PhD         
Sponsors and Collaborators
Westside Medical Associates of Los Angeles
Gilead Sciences
  More Information

No publications provided

Responsible Party: David Gallegos, RN, Principal Investigator, Westside Medical Associates of Los Angeles
ClinicalTrials.gov Identifier: NCT01804543     History of Changes
Other Study ID Numbers: IN-US- 259-0140
Study First Received: August 3, 2012
Last Updated: March 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Heart Diseases
Ischemia
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014