Severe Coronary Artery DiseaseNCT03257683
RANOLAZINE STUDY: Speckle Tracking Derived Myocardial Strain
An observational study of Severe Coronary Artery Disease and Ischaemic Myocardial Dysfunction, run by Saint Thomas Health at 1 site in United States.
Trial summary
The purpose of this study is to collect data to determine if the medication, Ranolazine, effects heart muscle function in patients who have areas of non-revascularizable heart muscle. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Severe Coronary Artery Disease, Ischaemic Myocardial Dysfunction
- What is being tested?
- Ranolazine
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2017to 16 Feb 2018
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population will be either male or female, age 18 or greater with stable GDMT for 60 days prior to enrollment. They will be in normal sinus rhythm with coronary artery revascularization more than 60 days prior to enrollment, with a non-revascularizable area of myocardial ischemia as determined by stress MRI. They will be able to perform the bicycle stress echocardiogram and able to provide written informed consent.
Who may be able to join
- age > 18 Stable GDMT for 60 days prior to enrollment Normal sinus rhythm Coronary artery revascularization > 60 days prior to enrollment Non-revascularizable area of myocardial ischemia as determined by stress MRI Able to perform the bicycle stress echocardiograms Able to provide written, informed consent Women of childbearing potential with negative pregnancy test at the index visit, and consent to use effective contraception throughout the study period and up to at least 14 days following the last dose of study drug
Who cannot join
- More than 1+MR, aortic stenosis, aortic insufficiency, mitral stenosis Serious co-morbidities with predicted life expectancy <1 year Patients not in normal sinus rhythm (NSR) Patients who have undergone coronary artery revascularization (PCI, CABG) within 60 days Pregnant or unknown pregnancy status Liver cirrhosis Patients unwilling/unable to provide written, informed consent Concomitant use of QTc prolonging drugs, potassium channel variants resulting in a long QT interval, patients with a family history of (or congenital) long QT syndrome, and patients with known acquired QT interval prolongation Concomitant use of strong CYP3A inhibitors including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir Concomitant use of CYP3A4 inducers such as rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort Breast feeding Atrial fibrillation or frequent atrial or ventricular ectopy Moderate CYP3A inhibitors (e.g., diltiazem, verapamil, erythromycin) P-gp inhibitors (e.g., cyclosporine) which increase ranolazine exposure Renal failure. Patients with Creatinine clearance less than 30ml/min . Safety Considerations for patients with the following drugs/conditions CYP3A substrates: Limit simvastatin to 20 mg when used with ranolazine. Doses of other sensitive CYP3A substrates (e.g., lovastatin) and CYP3A substrates with narrow therapeutic range (e.g., cyclosporine, tacrolimus, sirolimus) may need to be reduced with ranolazine OCT2 substrates: Limit the dose of metformin to 1700 mg daily when used with ranolazine 1000 mg twice daily. Doses of other OCT2 substrates may require adjusted doses Drugs transported by P-gp (e.g., digoxin), or drugs metabolized by CYP2D6 (e.g., tricyclic antidepressants) may need reduced doses when used with ranolazine Renal failure: Patients with creatinine clearance less than 30ml/min are excluded from participation in this study. Monitor renal function after initiation and periodically in patients with moderate to severe renal impairment (CrCL < 60 mL/min). If acute renal failure develops, discontinue ranolazine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Thomas Heart at Saint Thomas West
Nashville, Tennessee, 37205
About this study
Official title: RANOLAZINE STUDY: The Effect of Ranolazine on Speckle Tracking Derived Myocardial Strain in Regions of Non-Revascularizable Ischemic Myocardium
The purpose of this study is to collect data to determine if the medication, Ranolazine, effects heart muscle function in patients who have areas of non-revascularizable heart muscle.
Read the detailed description
Many cardiac patients with severe coronary artery disease have areas of ischemic LV myocardium that cannot be revascularized (Non-R). The investigators propose to identify such patients via retrospective case review of CMRI data, as well as identify the exact regions which specify Non-R coronary anatomy. This selected study group will have a specific echocardiographic imaging protocol performed, which includes the known ischemic regions. All segments will be collected and analyzed as a pre-therapeutic baseline using specialized STE software to derive strain values. Following eight (8) weeks of ranolazine therapy, each subject will be re-interrogated with the same echocardiographic imaging protocol and have identical measurements of regional strain performed. Ranolazine will be added to the patients' usual medical therapy. Each patient will serve as their own control, from baseline to post therapeutic state.
It is the hypothesis of the investigators, that additional therapeutic dosing of ranolazine will improve regional and perhaps global myocardial function. Improvement in LV mechanical function (regional and global) will be quantitated and objectively elucidated by STE derived myocardial strain as described further in this document.
- Being tested
- Ranolazine
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanolazineDrug
Study group will receive additional therapeutic dosing of drug.
| Study group | Role | What they receive |
|---|---|---|
| Selected group with cardiac ischemia | This selected study group will have a specific echocardiographic imaging protocol performed, which includes the known ischemic regions. All segments will be collected and analyzed as a pre-therapeutic baseline using specialized STE software to derive strain values. Following eight (8) weeks of ranolazine therapy, each subject will be re-interrogated with the same echocardiographic imaging protocol and have identical measurements of regional strain performed. Ranolazine will be added to the patients' usual medical therapy. Each patient will serve as their own control, from baseline to post therapeutic state. Receives: Drug: Ranolazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of strain
Changes in 3D regional left ventricular myocardial strain assessed by speckle-tracking
Measured: 8 weeks
Secondary outcomes (1)
Left ventricular function
2D global longitudinal strain and various other echo parameters of left ventricular function
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start14 Apr 2017
- Primary completion16 Nov 2017
- Study completion16 Feb 2018
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Coronary Artery DiseaseStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas J Pearce, MD, Principal investigator, Saint Thomas Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257683
- Sponsor's protocol ID
- STH 16-012
- Status last verified
- Apr 2018
- First submitted
- 25 Jul 2017
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RANOLAZINE STUDY: The Effect of Ranolazine on Speckle Tracking Derived Myocardial Strain in Regions of Non-Revascularizable Ischemic Myocardium
- ClinicalTrials.gov ID
- NCT03257683
- Acronym / sponsor ID
- STH 16-012
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Saint Thomas HealthUniversity, hospital or other
- Study start
- 14 Apr 2017 (actual)
- Primary completion
- 16 Nov 2017 (actual)
- Study completion
- 16 Feb 2018 (actual)
- First posted
- 22 Aug 2017 (actual)
- 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.
The purpose of this study is to collect data to determine if the medication, Ranolazine, effects heart muscle function in patients who have areas of non-revascularizable heart muscle.
Detailed description
Many cardiac patients with severe coronary artery disease have areas of ischemic LV myocardium that cannot be revascularized (Non-R). The investigators propose to identify such patients via retrospective case review of CMRI data, as well as identify the exact regions which specify Non-R coronary anatomy. This selected study group will have a specific echocardiographic imaging protocol performed, which includes the known ischemic regions. All segments will be collected and analyzed as a pre-therapeutic baseline using specialized STE software to derive strain values. Following eight (8) weeks of ranolazine therapy, each subject will be re-interrogated with the same echocardiographic imaging protocol and have identical measurements of regional strain performed. Ranolazine will be added to the patients' usual medical therapy. Each patient will serve as their own control, from baseline to post therapeutic state.
It is the hypothesis of the investigators, that additional therapeutic dosing of ranolazine will improve regional and perhaps global myocardial function. Improvement in LV mechanical function (regional and global) will be quantitated and objectively elucidated by STE derived myocardial strain as described further in this document.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selected group with cardiac ischemia | – | Drug: RanolazineThis selected study group will have a specific echocardiographic imaging protocol performed, which includes the known ischemic regions. All segments will be collected and analyzed as a pre-therapeutic baseline using specialized STE software to derive strain values. Following eight (8) weeks of ranolazine therapy, each subject will be re-interrogated with the same echocardiographic imaging protocol and have identical measurements of regional strain performed. Ranolazine will be added to the patients' usual medical therapy. Each patient will serve as their own control, from baseline to post therapeutic state. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be either male or female, age 18 or greater with stable GDMT for 60 days prior to enrollment. They will be in normal sinus rhythm with coronary artery revascularization more than 60 days prior to enrollment, with a non-revascularizable area of myocardial ischemia as determined by stress MRI. They will be able to perform the bicycle stress echocardiogram and able to provide written informed consent.
Key inclusion criteria (1 listed)
- age > 18 Stable GDMT for 60 days prior to enrollment Normal sinus rhythm Coronary artery revascularization > 60 days prior to enrollment Non-revascularizable area of myocardial ischemia as determined by stress MRI Able to perform the bicycle stress echocardiograms Able to provide written, informed consent Women of childbearing potential with negative pregnancy test at the index visit, and consent to use effective contraception throughout the study period and up to at least 14 days following the last dose of study drug
Key exclusion criteria (1 listed)
- More than 1+MR, aortic stenosis, aortic insufficiency, mitral stenosis Serious co-morbidities with predicted life expectancy <1 year Patients not in normal sinus rhythm (NSR) Patients who have undergone coronary artery revascularization (PCI, CABG) within 60 days Pregnant or unknown pregnancy status Liver cirrhosis Patients unwilling/unable to provide written, informed consent Concomitant use of QTc prolonging drugs, potassium channel variants resulting in a long QT interval, patients with a family history of (or congenital) long QT syndrome, and patients with known acquired QT interval prolongation Concomitant use of strong CYP3A inhibitors including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir Concomitant use of CYP3A4 inducers such as rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort Breast feeding Atrial fibrillation or frequent atrial or ventricular ectopy Moderate CYP3A inhibitors (e.g., diltiazem, verapamil, erythromycin) P-gp inhibitors (e.g., cyclosporine) which increase ranolazine exposure Renal failure. Patients with Creatinine clearance less than 30ml/min . Safety Considerations for patients with the following drugs/conditions CYP3A substrates: Limit simvastatin to 20 mg when used with ranolazine. Doses of other sensitive CYP3A substrates (e.g., lovastatin) and CYP3A substrates with narrow therapeutic range (e.g., cyclosporine, tacrolimus, sirolimus) may need to be reduced with ranolazine OCT2 substrates: Limit the dose of metformin to 1700 mg daily when used with ranolazine 1000 mg twice daily. Doses of other OCT2 substrates may require adjusted doses Drugs transported by P-gp (e.g., digoxin), or drugs metabolized by CYP2D6 (e.g., tricyclic antidepressants) may need reduced doses when used with ranolazine Renal failure: Patients with creatinine clearance less than 30ml/min are excluded from participation in this study. Monitor renal function after initiation and periodically in patients with moderate to severe renal impairment (CrCL < 60 mL/min). If acute renal failure develops, discontinue ranolazine.
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 |
|---|---|---|
| RanolazineStudy group will receive additional therapeutic dosing of drug. | Drug | Selected group with cardiac ischemia |
Primary outcome
Measurement of strain
Time frame: 8 weeks
Changes in 3D regional left ventricular myocardial strain assessed by speckle-tracking
1 secondary outcome
Left ventricular function
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Douglas J Pearce, MD principal investigator
Saint Thomas Health
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 Severe Coronary Artery Disease and Ischaemic Myocardial Dysfunction, run by Saint Thomas Health 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 10 Apr 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of strain (time frame: 8 weeks). 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 10 Apr 2018.