AnginaNCT01804543
Impact of Ranolazine on Myocardial Ischemia Detected by High-Field 3T Cardiovascular Magnetic Resonance (CMR) Imaging and P-31 Spectroscopy
An observational study of Angina and Heart Disease, run by Westside Medical Associates of Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina, Heart Disease
- What is being tested?
- Ranolazine
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject with chest pain or equivalence (atypical chest pain, shortness of breath, or fatigue)
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Westside Medical Associates of Los Angeles
Beverly Hills, California, 90211
David Gallegos, RN, 310-289-9955, david@westsidecardio.com
Gabriel Vorobiof, MD
About this study
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.
Read the 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.
- Conditions
- Angina, Heart Disease
- Being tested
- Ranolazine
- Medical subject headings
- Angina Pectoris, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanolazineDrug
Also called Ranexa
ranolazine 500 mg, then 1000 mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| Angina, Heart Disease | ranolazine 500 mg twice daily for 1 week, then 1000 mg twice daily for 3 weeks Receives: Drug: Ranolazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
parameters of cellular ischemia by 31P MRS
Measured: post 4 weeks of therapy with ranolazine
Secondary outcomes (1)
myocardial perfusion indices
Measured: post 4 weeks of therapy with ranolazine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Westside Medical Associates of Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, David Gallegos, RN, Westside Medical Associates of Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804543
- Sponsor's protocol ID
- IN-US- 259-0140
- Status last verified
- Mar 2013
- First submitted
- 3 Aug 2012
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ranolazine on Myocardial Ischemia Detected by High-Field 3T Cardiovascular Magnetic Resonance (CMR) Imaging and P-31 Spectroscopy
- ClinicalTrials.gov ID
- NCT01804543
- Acronym / sponsor ID
- IN-US- 259-0140
- Conditions
- Angina, Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Westside Medical Associates of Los AngelesUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 5 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Angina, Heart Disease | – | Drug: Ranolazineranolazine 500 mg twice daily for 1 week, then 1000 mg twice daily for 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject with chest pain or equivalence (atypical chest pain, shortness of breath, or fatigue)
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RanolazineAlso: Ranexaranolazine 500 mg, then 1000 mg twice a day | Drug | Angina, Heart Disease |
Primary outcome
parameters of cellular ischemia by 31P MRS
Time frame: post 4 weeks of therapy with ranolazine
1 secondary outcome
myocardial perfusion indices
Time frame: post 4 weeks of therapy with ranolazine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina and Heart Disease, run by Westside Medical Associates of Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Gallegos, RN ((310) 289-9955, david@westsidecardio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
parameters of cellular ischemia by 31P MRS (time frame: post 4 weeks of therapy with ranolazine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2013.