The Central Minnesota Heart Center Research Department opens new clinical trials on a regular basis. For information on these or additional studies that may be open and available to treat, control or prevent heart disease, please contact the research department at (320) 251-2700, ext. 57584 or e-mail wipperj@centracare.com.

A sample of cardiovascular research trials currently open to enrollment at the Central Minnesota Heart Center is listed below.

Prevention Trials

Tecos Study - The purpose of this study is to test the safety and effectiveness of Sitagliptin (trade name JANUVIA™) in patients with Type 2 Diabetes with a history of cardiovascular disease. Sitagliptin is an FDA approved drug available by prescription for control of blood sugar for those with Type 2 Diabetes. Patients will be randomized to receive either Sitagliptin or Placebo in addition to their normal standard of care. The dose of Sitagliptin (100 mg or 50 mg) will be determined by the patients kidney function and may be adjusted. Patients will return for study visits at Month 4, Month 8, Month 12, and then every six months until the end of study visit. Patient may be in the study up to 6 years. Principal Investigator: Bernard Erickson, MD

DAPT Study - The purpose of this study is to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet therapy (DAPT) in subjects undergoing percutaneous coronary intervention (PCI). Subjects may be enrolled into the study either before or after the index procedure. Enrollment can occur up to 24 hours post procedure. All enrolled subjects will be treated with either a drug eluting or bare metal stent and assigned to 12 months of open label DAPT treatment in addition to aspirin. All enrolled subjects who are considered “12 Month Clear” are eligible for randomization to either placebo or an additional 18 months of DAPT treatment. Both arms will continue with aspirin therapy. “12 Month Clear” is defined as subjects who are event free (from all death, MI, stroke, repeat coronary revascularization, stent thrombosis and major bleed). Follow-up will consist of telephone and clinic visits for 18 months followed by an additional 3 month observational period. Principal Investigator: Bernard Erickson, MD

Borealis - The purpose of this study is to evaluate whether once weekly subcutaneous injections of biotinylated idraparinux (investigational) is at least as effective as oral International Normalized Ratio (INR) adjusted-dose warfarin in the prevention of stroke or systemic embolic event in patient with atrial fibrillation (AF). Patients with AF and an indication for long-term VKA therapy are potentially eligible for this study. The patients treatment duration will vary depending on the total duration of the study. The minimum treatment duration will be 6 months for the last patient enrolled in the study. All patients will visit the clinic once every three months for clinical assessment. In addition, visits after 1 week, 2 weeks and 7 weeks post randomization will be scheduled. Monitoring of the INR will need to be done at least once per month, after an initial period following randomization where more frequent checks of INR might be requested to obtain stable INR values within the targeted range. Principal Investigator: Bernard Erickson, MD

IMPROVE-IT - The purpose of this study is to evaluate the clinical benefit of Ezetimibe/Simvastatin (Vytorin) compared with Simvastatin (Zocor) in stabilized acute coronary syndrome patients. Clinical benefits are defined as the reduction in the risk of the occurrence of the composite endpoint of CV death, major coronary events, and non-fatal stroke. The overall study length is anticipated to last 2 ½ - 5 years. Subjects will be seen in follow-up at 1 month, 4 months and every 4 months, thereafter. Principal Investigator: Bernard Erickson, MD

PRECISION Study - The purpose of this study is to assess the effects of celecoxib (CELEBREX) when compared to traditional (non-selective) nonsteroidal anti-inflammatory drugs on cardiovascular events, gastrointestinal events, renal events and symptomatic benefits in subjects with osteoarthritis or rheumatoid arthritis with cardiovascular disease or at high risk for developing CVD. Patients will be randomized to receive one of three sets of the following study drugs: celecoxib, ibuprofen, or naproxen. The testing of celecoxib compared to ibuprofen, or naproxen is investigational. The overall study length is anticipated to last 36 – 42 months. Principal Investigator: Bernard Erickson, MD

Roche NC20971 - The primary objective of this study is to evaluate the potential of RO4607381 (study drug) to see if it will reduce the risk of death from cardiovascular disease or having a cardiovascular event such as myocardial infarction (heart attack), stroke (brain attack), revascularization procedures (angioplasty, implanting a stent) or hospitalization for acute coronary syndrome (chest pain not associated with physical exertion and electrocardiogram [ECG] abnormalities) Patients will be randomized to receive either the study drug or placebo in a 1:1 ratio. Approximately 15,600 patients will be enrolled in this trial. Patients will be followed for a minimum of 2 years and possibly up to 5 years. During the first year of the treatment period, patients will be seen in the clinic at 1 month and 3 months after randomization and every 3 months thereafter. During the remaining years patients will be seen in clinic every 4 months until study completion. Principal Investigator: Bernard Erickson, MD

Stability - The purpose of this study is to evaluate clinical efficacy of long-term treatment with Darapladib enteric coated tablets, 160 mg (oral once daily dose) as compared to placebo when added to standard of care in a chronic coronary heart disease (CHD) patient population on the incidence of first occurrence of the composite of MACE (i.e., CV death, non-fatal MI, non-fatal stroke). Neither the subject nor the study staff will know which of the two treatments (Darapladib or placebo) the subject is receiving. During the Treatment Phase, subjects will return for scheduled clinic visits at Month 1, Month 3, Month 6 and then every 6 months thereafter for the duration of the study. In addition, scheduled telephone visits will be conducted beginning at Month 9 and then every 6 months thereafter for the duration of the study. Principal Investigator: Bernard Erickson, MD

Tracer Study - This research study involves the use of an investigational drug, SCH 530348 (the study drug). The purpose of this research study is to evaluate the clinical benefit of the study drug and how it may reduce the complications related to coronary events when given to patients with a history of chest pain. Approximately 10,000 patients at 800 centers will be enrolled. Patients will be followed at 30 days, 4, 8, and 12 months; and then every 6 months thereafter until the end of the study. Principal Investigator: Bernard Erickson, MD

Heart Failure Trials

CARRESS-HF - The purpose of this study is to test if ultrafiltration compared to stepped pharmacologic care will result in improved renal function and relief of congestion in patients hospitalized with acute decompensated heart failure (ADHF) and cardiorenal syndrome. Subjects will be followed through the duration of their hospitalization and will also be asked to return to the clinic at 30 days and 60 days after enrollment. Principal Investigator: Tim Schuchard, MD

DOSE-AHF -This study will evaluate different ways of giving IV furosemide (Lasix®) to see which one works best for patients hospitalized with heart failure. Heart failure is a very common disorder in which the heart cannot pump enough blood to meet the needs of the rest of the body. Patients will be followed at 6, 12, 24, 48, 72 and 96 hours and 60 days from the time of study enrollment. Principal Investigator: Tim Schuchard, MD

Intervention Trials

Sapphire-WW - This study utilizes the Cordis PRECISE® Nitinol Stent Systems, the Cordis ANGIOGUARD™ XP/RX Emboli Capture Guidewire and next generation Cordis carotid stents and EPDs as they become commercially available. The study population will consist of high-surgical risk patients with atherosclerotic disease of the carotid artery(ies). Subjects will be seen in follow-up at 30 days and have a telephonic interview conducted a 12 months to establish the occurrence of any major adverse events. The study is expected to enroll 10,000 patients at 350 sites. Principal Investigator: Bernard Erickson, MD

Protect II - The purpose of this study is to evaluate the safety and effectiveness of the IMPELLA RECOVER 2.5 System for use during coronary artery interventions compared to intra aortic balloon pump. Approximately 650 subjects will take part in the study in about 150 hospitals in the US, Canada and Europe. A subject’s participation is expected to last approximately 3 months with in clinic follow-up occurring at 30 days and 3 months. Principal Investigator: Bernard Erickson, MD

Spirit SV - The objective of this study is to evaluate the safety and effectiveness of the 2.25 mm XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter in subjects with ischemic heart disease due to a maximum of two de novo native coronary artery lesions, each in a different epicardial vessel, in small vessels (>2.25 mm to <2.25 mm in diameter). The XIENCE V EECSS 2.25 mm has the same stent design, delivery system, coating materials, and coating processes as the XIENCE V EECSS 2.5, 2.75, and 3.0 mm. A total of 250 patients will be enrolled at up to 50 sites in the US. Patients will be seen in follow-up at 30 days (clinic visit), 240 days (clinic visit), 1, 2, 3, 4 and 5 years (clinic or telephone visit). The first 150 patients enrolled in the study who receive a 2.25 mm XIENCE V EECS will undergo a 2nd angiogram at the 240 day visit. Principal Investigator: Bernard Erickson, MD

Device/Electrophysiology Trials

OPTIVOL Care Pathway Study - The purpose of this study is to compare monthly versus quarterly review of Cardiac Compass® Trends with OptiVol for initiation of clinical action. Clinical action may include: medication change, device reprogramming, medication compliance counseling, dietary counseling, clinic visit, ER or urgent care visit, and health care referral. Subjects who enroll will have met all inclusion/exclusion criteria, including having received a Medtronic ICD or CRT-D device, which contains Cardiac Compass Trends and OptiVol Fluid Status Monitoring Features. Currently our “standard of care” is to monitor these patients quarterly, although they may be monitored more frequently if medically necessary. These visits will occur either in office or via CareLink transmission. Subjects will be required to answer questions related to their heart failure following each visit and also be required to complete a Self-Care of Heart Failure Index survey three times during the study. The study is expected to enroll approximately 1,500 patients in the U.S., at up to 200 study centers. Subject participation will last for 12 months following their start date. Principal Investigator: Simón Milstein, MD

BRAVO CRT-D Study - The purpose of this study is to evaluate the relationship between CRT atrioventricular delay settings and chemical markers of heart failure. Subjects will be randomized to one of three methods of determining settings for atrioventricular delay. All arms will be based on the intrinsic A-V interval measured by using the A-sense to the first V-sense using intracardiac electrograms measured through the implanted device. Subjects will be followed for a total of sixth months, with scheduled visits at 24 hours and at one month, three months and six months post implant. It is expected that approximately 100 subjects, not to exceed 150, will be enrolled over a 24-month period at no more than 20 US centers. Principal investigator: Mevan Wijetunga, MD