Clinical Trials - Mercy Hospital

Clinical trials are currently being conducted for the following medical conditions.

Therapeutic Area	Medical Condition
Cardiology	Cardiomems Determine reduction of hospitalization related to disease progression with Heart Failure Pressure Measurement System to treat heart failure patient. CardioMEMS is an implantable intravascular pressure sensor. Implanted in the pulmonary vessel during right heart catheterization. By providing Systolic, Diastolic, and Mean pressure readings as well as Cardiac Output readings along with cardiac wave forms, the physician is able to monitor a patient remotely via web based link with patients home based reading device. This allows the physician to adjust patient’s medications before increasing heart failure symptoms are present reducing incidents of hospitalization for heart failure.

	Champion PCI To demonstrate the efficacy of Cangrelor is superior to Clopidogrel (Plavix). Cangrelor is given IV producing a quicker onset of action allowing the patient to receive definitive care in less time then those patients loaded with Clopidogrel prior to PCI.

	Early ACS To demonstrate the superiority of early eptifibatide, administered as a double bolus plus infusion, compared to placebo (with provisional use of eptifibatide in the catheterization laboratory) in reducing the composite of death, myocardial infarction (MI), recurrent ischemia requiring urgent revascularization (RI-UR), and thrombotic bail-out (TBO).

	FREEDOM Patients are enrolled within 2 weeks post CRT-D device implant. All participants must be implanted with an SJM CRT-D device with V-V timing and a compatible lead system. Patients implanted with chronic leads requiring device upgrade to CRT-D can also be enrolled in the study, provided they are receiving a CRT-D device for the first time. Patients are followed up to 12 months post implant with data collected at enrollment, 3 months, 6 months, 9 months, 12 months and at any unscheduled follow-up visits.

	Improve-It Clinical Benefit and Safety of Vytorin vs Simvastatin Monotherapy in High Risk subjects presenting with Acute Coronary Syndrome. Adult subjects admitted with diagnosis of high-risk ACS will be selected for the study.

	Pace MI Patients within one month of a myocardial infarction who have either bradycardia or heart block contraindications to beta blockers will be randomized to received either standard post myocardial infarction therapy or standard therapy plus a pacemaker and beta-blockers.

	WARCEF Patients with low left ventricular ejection fraction will be followed for 2-6 years to determine if warfarin (with target INR of 2.75 + 0.25) is superior to aspirin (325 mg per day) for prevention of ischemic stroke, intracerebral hemorrhage, or death. WARCEF is an intent-to-treat trial, so all patients, even those who discontinue study medication, are followed until they develop a primary endpoint or the trial ends.

ENT	Otologics To evaluate the safety and effectiveness of the Fully Implantable MET Ossicular Stimulator, a fully implantable hearing device designed to address the amplification needs of adults (18 years of age or older) with moderate to severe sensorineural hearing loss, through mechanical stimulation of the ossicles.

Neurology	BIOGEN IDEC A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis.

Oncology	A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination with Erlotinib in Non-Small Cell Lung Cancer Patients.

	Pfizer Breast Cancer To demonstrate whether the combination of sunitinib plus capecitabine is superior to capecitabine monotherapy in prolonging the progression free survival (PFS) for patients with previously treated breast cancer.

Radiation Oncology	RTOG 0517 To determine if the addition of a radionucleotide (strontium-89 [SR-89] or Samarium-153 [Sm-153] to bisphosphonates for patients with asymptomatic or stable symptomatic bone metastases will delay the time to development of malignant skeletal related events defined as a pathological bone fracture, spinal cord compression, surgery to bone or radiation to bone.

Surgery	POI 301 This study will examine the effect of IV MOA-728 versus placebo in shortening the time to return of bowel function in subjects receiving opioid analgesia administered via PCA, who have undergone repair of large ≥10 cm, measured from edge to edge in its greatest dimension) ventral hernias with or without a mesh prosthesis.

For more information about the Mercy Research Institute please call 305-285-2792.