The Health Alliance participates in many clinical trials. Clinical trials are a formal, regulated way to test new treatments, such as drugs or equipment. The Health Alliance is renowned for its research into various cardiovascular treatments, and clinical trials are one way that research is conducted.

If you're interested in learning more about a clinical trial, talk to your physician.

2000-2002 Research Studies from
The Jewish Hospital Cholesterol Center

Retinal Vein Thrombosis: Retinal vein occlusion (RTV) is a severely debilitating problem, often causing reduced visual acuity, blindness, and neovascular glaucoma. It may occur in both eyes in up to 25% of cases, and is a common cause of blindness.  The aim of this study is to determine whether inherited thrombophilia (increased tendency to develop blood clots) and hypofibrinolysis (reduced ability to break up clots) are risk factors for retinal vein occlusion.  Because RTV may occur in the other eye, we are examining anticlotting therapy as an approach to prevent blindness.

Polycystic Ovary Syndrome (PCOS):  this is an inherited abnormality that results in hyperinsulinemia which can lead to multiple endocrine problems including infertility.  In this study, Metformin therapy is used to reverse the hyperinsulinemia, and ultimately, correct the endocrine problems.   This may also reduce the risk of developing heart disease after menopause.

Pseudotumor Cerebri: is benign intracranial hypertension which may result in headaches and loss of vision.  We are assessing what part thrombophilia (increased tendency to develop blood clots) and hypofibrinolysis (reduced ability to break up clots) play in this disorder.  By treating these underlying causes, we hope to improve the headaches and vision loss.

If you are interested in participating in any of the studies, please call 513-585-7800.

Research Trials from the 
Lindner Clinical Trial Center 

Hyperlipidemia/Hypercholesterolemia

The Lindner Clinical Trial Center is an independent research organization focused on bringing promising new treatments to the citizens of the Greater Cincinnati community. The Center currently administers approximately 60 active trials involving coronary artery disease, systemic hypertension, cholesterol and lipid abnormalities, diabetes and peripheral vascular disease. The Lindner Clinical Trial Center’s objective remains “working with you and your physician to provide better care”. 

Stent coated with a drug that may reduce restenosis

SIRIUS (rapamycin) coated stent to eliminate restenosis (recurring clogging of heart’s arteries following stent implantation). Rapamycin is a medication used in oncology that interferes with the normal cell growth cycle. Experimental models and a Phase I study in man have demonstrated marked reduction in the scar tissue response to stent deployment. In the Phase I study performed in Europe and South America, little or no scar tissue response was noted in patients following stent deployment. This observation stands in stark contrast to the typical scar tissue response that follows coronary stent deployment. The SIRIUS trial will randomly compare a rapamycin-coated stent to the identical stent without the rapamycin drug coating. This trial is required to definitively prove the benefit of rapamycin drug coating. Patients will be randomly allocated to the drug-coated stent (vs. non-drug coated stent) in a 1:1 (50-50) ratio. Neither investigator nor patient will know whether the drug coated or standard stent has been deployed until the trial is terminated. All patients will have a follow-up angiogram at 6 months following coronary stent deployment. The research protocol driven follow-up angiogram will be performed at no cost to the patient or their insurance carrier. The rapamycin-coated stent is currently an investigational device and this protocol has been approved by the Institutional Review Board of The Christ Hospital. 

Congestive Heart Failure (CHF) Trials

Stamina Trial – Use of darbopoetin alpha, an agent that stimulates the production of red blood cell (RBCs) in patients with heart failure and anemia. RBCs are the vehicles by which oxygen gets to various parts of the body. In heart failure, the ability of the heart to pump blood is reduced. Complicating that with less available red blood cells, as in the case of anemia, patients receive less oxygen, are physically unable to be active, and feel poorly. This study seeks to determine if darbopoetin can increase the patient’s well-being and stability to the failing heart. The goal is to reduce re-hospitalizations and enhance quality of life in these seriously ill patients.

Companion – use of biventricular pacemaker in patients with heart failure. This trial evaluates the use of medical therapy, dual chamber heart pacing, and the use of ICD (internal cardiac defibrillator) in treating the CHF patient. Call 513-585-1777 for more information.

EECP (Enhanced External Counter Pulsation) uses mechanical augmentation accomplished through blood pressure cuffs placed on the lower extremities to improve left ventricular function and reduce congestive heart failure symptoms.
Call 513-585-1777.

STICH – this trial treats and compares heart failure patients with medical or surgical treatment. The surgical treatment may be that of routine coronary bypass surgery or cardiac remodeling procedures. This remaining surgery is performed on the area of the heart that is not effectively pumping. It reduces the size of the chamber making it stronger and more efficient. This project looks at the long-term success of these procedures in relation to patients treated with medical therapy alone. Call 513-585-1777 for more information.

REVIVE – use of levosimendan in decompensated chronic heart failure; short series of infusion given to enhance cardiac output and efficiency. Call 513-585-1777 for more information.

Interventional Trials

ULTIMA – use of sirolius drug-coated stent for patients with blockages in their left main coronary artery. This serious blockage routinely is treated with coronary artery bypass surgery. This trial allows percutaneous implantation stent on a select group of patients. Call 513-585-1777 for more information.

Prefer – use of a drug-coated stent for patients with blockages in their coronary arteries. The drug is believed to prevent cells from growing and causing future blockages. Patients will receive one of two drug coated stents or an uncoated stent. Outcomes will be compared in all patient groups. Call 513-585-1777 for more information.

Distal Protection Devices

The Lindner Center has two distal protection devices available to physicians for treatment of coronary vessel blockages. Vessels that are known to have significant debris or lesions with complex blockages are commonly complicated when this debris travels downstream and blocks blood flow to other parts of the heart. These devices serve as filters to catch this debris and remove it from the body. Call 513-585-1777 for more information.

Re-radiation for patients who have failed interacornary coronary radiation - Patients who have previously been treated by an intracorarary radiation may be re-treated under this special study protocol. Radiation appears to inhibit cell growth and recurrence of blockage in the vessel. Theories exist that the initial treatment may need to be repeated in the case of some difficult lesions. This will serve as a pilot trial to assess patient safety and long term outcome. Call 513-585-1777 for more information.

FGF in chronic ischemia disease - Patients with chronic blockages in their coronary arteries who are being treated medically but continue to have angina may be candidates for this angrogenesis agent. It is a naturally occurring protein in the body that stimulates the growth of new vessels or collateral circulation. This project evaluates the agent’s ability to do this and the resulting effect upon the patient as it relates to the degree of angina and overall quality of life. Call 513-585-1777 for more information.

Electrophysiology trials

Azimilioe in atrial fibrillation - An anti-arrhythmic agent is be being tested in the area of controlling and preventing atrial fibrillation. This agent has been studied in the past with early studies demonstrating its effectiveness in treating this coronary problem. Call 513-585-1777 for more information.

Syncrus – Pacing wires for atrial fibrillation after coronary artery bypass graft (CABG) surgery. Special wires are placed to treat the potential arrhythmias seen after coronary bypass surgery. In the event the patient experiences artial fibrillation, the wires are attached to the device, electrically converting the heart rhythm back to normal at low energy levels. Call 513-585-1777 for more information.

Peripheral Vascular Disease Carotid Disease Trials

ASPIRE - use of Aspire stent to treat blockages in the iliac vessels of the leg. These blockages commonly affect the ability of the patients to walk any distances, resulting in leg pain, and continuous serious circulatory problems of the lower leg and foot. Call 513-585-1777 for more information.

CABERNET Study - Evaluation of stenting of carotid arteries with serious blockages. Current therapy involves surgical intervention, that is, carotid endarterectomy. This protocol combines a stent and a distal protection device a filter that prevents any micscocopic debris from entering the circulation and traveling to the brain or other small vessels, eliminating the need for surgical intervention. All patients are treated with this new device. Outcomes will be compared to historical data obtained on surgically treated patients. Call 513-585-1777 for more information.

Prevention Trials

Diabetes

The Lindner Center has several diabetic trials including an inhaled insulin project for patient with underlying pulmonary disease. Call 513-585-1777 for more information.

Hypertension

Advanced endovascular regimens and new compounds are being investigated in patients with mild to moderate hypertension. Many projects offer patient travel stipend and long-term treatment phases that continue to provide free study medication to participants. Call 513-585-1777 for more information.

Hyperlipidemia/Hypercholesterolemia

High cholesterol is a significant risk factor for coronary disease. The Lindner Center has several new agents under study at this time that appear promising in lowering LDL (bad cholesterol). The Center is also involved in investigating a vaccine that may raise HDL (good cholesterol) in patients with dangerously low levels. Call 513-585-1777 for more information.