Clinical Research
In clinic and hospital settings, research trials are performed with patients who generously give doctors, and those in the cardiovascular research and healthcare industry, the opportunity to further study cardiovascular disease. The cardiologists at The Dallas Heart Group have been active in this research for over 20 years, advancing new preventive and treatment options for our patients. These studies are vital and allow us to provide leading edge treatments to our patients who are involved in these investigative trials. We are grateful to our patients who take part in them.
Why do we participate in clinical trials?
Our physicians believe that by studying new medications and treatment options for cardiovascular disease, they will be able to offer a higher level of care to their patients.
What criteria must the patient meet to participate in a trial?
Each clinical study has specific criteria to which the patient must meet. These guidelines relate to the patient’s condition and determine whether he/she is qualified to participate. If considering whether to participate in a study or not, it is best to speak with your physician about any concerns or questions you may have.
How do I find out more about the clinical trials that my doctors are involved with?
If you have a heart-related condition and would like to participate in a trial, speak with your Dallas Heart Group cardiologist first. You may also contact our research organization at Medical City Dallas Hospital at www.crsti.org to learn more about our clinical trials. Or, you may call CRSTI at 972-566-6820 and speak to a research coordinator. For more information about studies being conducted at the HEART HOSPITAL Baylor Plano, please call 469-814-4712.
What specific trials are The Dallas Heart Group physicians investigating?
PARTNER TRIAL
Medical City Dallas Hospital
Principal Investigator: David Brown, M.D., F.A.C.C.
Co-investigator: Bruce Bowers, M.D., F.A.C.C.What it is:
The Partner Trial stands for: Placement of AoRTic traNscathetER valvesEligibility: (For a full listing of eligibility criteria, please contact Research at CRSTI)
- You may be eligible for this trial if you have critical aortic heart valve stenosis (a narrowing of the valve that restricts blood flow
CHOICE TRIAL
THE HEART HOSPITAL Baylor Plano
Principal Investigator: Bruce Bowers, M.D., F.A.C.C.
Co-investigator: David Brown, M.D., F.A.C.C.What it is:
The CHOICE trial stands for: Carotid Stenting for High Surgical-Risk Patients; Evaluating Outcomes Through The Collection of Clinical Evidence)Eligibility: (For a full listing of eligibility criteria, please contact Research at the Heart Hospital)
- Patient must be considered high risk for carotid endarterectomy.
- Patient requires percutaneous carotid angioplasty and stenting for carotid artery disease.
- Physician intends to use the RX Acculink™ with the RX Accunet™ Embolic Protection System or the Xact with the Emboshield as per the FDA approved indications for use.
SAPPHIRE TRIAL
THE HEART HOSPITAL Baylor Plano
Principal Investigator: Bruce Bowers, M.D., F.A.C.C.
Co-investigator: David Brown, M.D., F.A.C.C.What it is:
The SAPPHIRE trial stands for: Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy "SAPPHIRE WW")Eligibility: (For a full listing of eligibility criteria, please contact Research at the Heart Hospital)
- High-surgical risk patients to be treated consistent with IFU labeling.
- Patient requires percutaneous carotid angioplasty and stenting for carotid artery disease.
- Physician intends to use the Cordis PRECISE™ Nitinol Stent Systems (5.5F and 6F) and the Cordis ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW) as per the FDA approved indications for use.
BALANCE TRIAL
Medical City Dallas Hospital
Principal Investigator: Eric Eichhorn, M.D., F.A.C.C.
What it is:
The BALANCE trial stands for the treatment of HyponatrEmia: BAsed on LixivAptan in NYHA class III-IV CHF Patients Evaluation.Eligibility: (For a full listing of eligibility criteria, please contact Research at CRSTI)
- Subject has either ischemic or non-ischemic cardiomyopathy with symptoms of NYHA class III or IV.
- Patient has LVEF < 35%.
- The subject has clinical evidence of volume overload such as paroxysmal nocturnal dyspnea, orthopnea, edema, increased JVP, and/or hepatic congestion with ascites.
- The subject is on a loop diuric prior to enrollment. Also must be on ACE1 unless there is evidence of intolerance or ARB. If subject on beta blocker therapy, must have been initiated at least three months prior to enrollment. If on spioronolactone, dose must be stable for at least 1 week prior to enrollment.
FREEDOM TRIAL
THE HEART HOSPITAL Baylor Plano
Principal Investigators: Principal Investigators: David Brown, M.D., F.A.C.C.,
Bruce Bowers, M.D., F.A.C.C.
What it is:
The FREEDOM trial stands for Future Revascularization Evaluation in Patients with Diabetes mellitus: Optimal management of Multivessel Disease.Eligibility: (For a full listing of eligibility criteria, please contact Research at the Heart Hospital)
- Diabetes mellitus (Type 1 or Type 2) – random plasma glucose >200 mg/dl or fasting plasma glucose of at least 126 mg/dl
- Angiographically confirmed multivessel CAD (Critical = 70% lesions in at least 2 major epidcardial vessels and in at least 2 separate territories – LAD, LCF, RCA)
- Angiographic characteristics amenable to both PDCI/DES and CABG.
CUPID TRIAL
Medical City Dallas Hospital
Principal Investigators: Principal Investigators: Eric Eichhorn, M.D., F.A.C.C.
What it is:
The CUPID trial evaluates the safety and feasibility of a single ante grade, ipicardial coronary artery infusion of up to four dose levels of AAV1 vector (MYDICAR) expressing the transgene for SERCA2a to subjects with ischemic or non-ischemic cardiomyopathy and NYHA Class III/IV symptoms of heart failure and to explore the activity/efficacy of MYDICAR in order to identify appropriate dose levels for future studies.Eligibility: (For a full listing of eligibility criteria, please contact Research at CRSTI)
- 18-75 years of age
- Ischemic or non-ischemic cardiomyopathy. Subjects with ischemic cardiomyopathy must have at least one major coronary vessel with TIMI grade 3 flow.
VIRGO TRIAL
THE HEART HOSPITAL Baylor Plano
Principal Investigators: Principal Investigators: Deepika Gopal, M.D., F.A.C.C.
What it is:
The VIRGO trial studies gender differences in heart disease and identifies key determinants of recovery in women 55 years of age and younger who have experienced an acute MI.Eligibility: (For a full listing of eligibility criteria, please contact Research at the Heart Hospital)
- Female, 55 years of age and younger who have had an acute MI.
