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

March 4, 2013 updated by: David Gallegos, RN, Westside Medical Associates of Los Angeles
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Westside Medical Associates of Los Angeles
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • Ranexa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
parameters of cellular ischemia by 31P MRS
Time Frame: post 4 weeks of therapy with ranolazine
post 4 weeks of therapy with ranolazine

Secondary Outcome Measures

Outcome Measure
Time Frame
myocardial perfusion indices
Time Frame: post 4 weeks of therapy with ranolazine
post 4 weeks of therapy with ranolazine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Westside Medical Associates of Los Angeles

Collaborators

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2013

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

August 3, 2012

First Submitted That Met QC Criteria

March 4, 2013

First Posted (ESTIMATE)

March 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 5, 2013

Last Update Submitted That Met QC Criteria

March 4, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IN-US- 259-0140

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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