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Cardiovascular Research and Clinical Trials

Your neighbors, co-workers and friends – people you see every day may be “medical heroes”. By participating in clinical research trials, volunteers help to further advancements in medical therapy and technologies for a variety of health care diseases. Every medication that is prescribed to you by your physician has undergone rigorous testing through clinical trials prior to FDA approval. Without this testing, life-saving effects could not be made available to the general public. MidMichigan Health is a part of that process in the Cardiovascular Research Department.

MidMichigan Health Cardiovascular Clinical Trial Research Team.The Cardiovascular Research Team from L-R: Sunita Vadakath, M.D., F.R.C.A., M.P.A., Cardiovascular Service Line Director; Marti Freeman, Research Assistant; Katie Kamyszek, RN BSN, Research Coordinator; Brenda Whitman, RN, MSN, Manager; Crystal Bendele, RN, Research Coordinator; William Felten, M.D., Medical Director of Research; Amy Cryderman, RN, CCRC, Research Coordinator; and Jamie Prior, RN, BSN, CCRC, Research Coordinator.

MidMichigan physicians have developed an international reputation for their research activities. Currently all of the Cardiovascular Physicians, Interventionists, Electrophysiologists, Physicians Assistants and Nurse Practitioners in the Cardiovascular Specialty are actively participating in screening for and monitoring the care of research participants.

Registered Nurse Research Coordinators screen Cardiologists' patients for individuals who meet specific criteria for studies and then collaborate with patients and physicians for enrollment.

The Cardiovascular Research Department conducts Phase II, III, and IV studies. Most are outcome studies, meaning the trials involve testing drugs and treatments on larger groups of volunteers after a safe dosage and initial side effects have been identified. Patients are regularly monitored, and data is collected that helps determine the effectiveness and safety of a treatment, including any different impacts across gender and race. Through the process, which is of no cost to volunteers, patients receive frequent medical care related to the clinical trial. They often develop relationships with MidMichigan Health staff that last beyond their volunteer experience. Misconceptions about clinical research trials are common. Volunteering is often portrayed negatively in television medical dramas and other media, leading to concerns about safety and necessity of the research. We follow rigorous patient screening and safety measures. The MidMichigan Health institutional Review Board also oversees all aspects of research done locally.

As “medical heroes” throughout the Great Lakes Bay Region, MidMichigan Health continues to participate in clinical research trials and remains a valuable resource in the fight against heart disease and the advancement of cardiovascular treatments.

If you are interested in participating in cardiovascular clinical research, please reach out to our office at (989) 631-2469 or cvresearch@midmichigan.org.

MidMichigan Cardiovascular Current Clinical Trials

Heart Failure Trials

  • CONNECT-HF: Care OptimizatioN through PatieNt and Hospital Engagement Clinical Trial for Heart Failure - is a large-scale, pragmatic, cluster-randomized clinical trial to evaluate the effect of 2 quality improvement (QI) initiatives compared with usual care on heart failure (HF) outcomes and HF quality of care metrics at 1 year after discharge for participants hospitalized with acute HF and reduced ejection fraction (EF). The interventions will include both a health-system engagement group (direct) and a participants engagement group (digital). MidMichigan has been randomly assigned to the Digital arm where patients will download the ‘Fabulous App’ that is interacting and gives them encouragement, med reminders, education, appointment reminders, etc.
    • Currently enrolling participants.
    • NCT: 03035474
  • GALACTIC-HF: A Double-blind, Randomized, Placebo-controlled Multicenter Study to Access the Efficacy of Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Rewduct Ejection Fraction. AMG 423
    • Currently enrolling participants.
    • NCT: 02929329

Cholesterol Trials

  • dal-GenE: A phgase III, double-blind, randomized placebo-controlled study to evaluate the effects of dalcetrapib on cardiovascualr (CV) risk in a genetically defined population wiht a recent Acute Coronary Syndrome (ASC): The dal-GenE trial
    • Currently enrolling participants.
    • NCT: 02525939
  • ESPERION CLEAR: Harmony Protocol 1002-040, A Randomized, Double-blind, Placebo-controlled, Multicenter Long-term Safety and Tolerability Study of ETC-1002 in Patients With Hyperlipidemia at High Cardiovascular Risk Who Are Not Adequately Controlled by Their Lipid-Modifying Therapy.

    • Enrollment goal met, patients in follow-up only.
    • NCT: 02666664

Further cholesterol studies are anticipated, call the Cardiovascular Research office at (989) 631-2469 to identify your interest and we will notify you of future studies that you may qualify for.

Peripheral Vascular Disease Trials

  • VOYAGER PAD: Vascular Outcomes studY of ASA alonG with rivaroxaban in Endovascular or surgical limb Revascularization for peripheral artery disease (PAD): An international, multicenter, randomized, double-blind, placebo controlled phase 3 trial investigation the efficacy and safety of rivaroxaban to reduce the risk of major thrombotic vascular events in patients with symptomatic peripheral artery disease undergoing lower extremity revascularization procedures.

    • Currently enrolling participants.
    • NCT: 02504216

Acute Myocardial Infarction / Heart Attack

  • PARADISE-MI: A multi-center, randomized, double-blind, active-controlled, parallelgroup Phase 3 study to evaluate the efficacy and safety of LCZ696 compared to ramipril on morbidity and mortality in high risk patients following an acute myocardial infarction. Protocol LCZ696G2301

    • Currently enrolling participants.
    • NCT: 02924727

Obesity/Cardiovascular Disease Trials

  • CAMELLIA: A Study to Evaluate the Effect of Long-term Treatment with BELVIQ (Lorcaserin HCL) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects with Cardiovascular Disease or Multiple Cardiovascular Risk Factors.
    • Enrollment goal met, patients in follow-up only.
    • NCT: 02019264

Diabetes (Type II) and Cardiovascular Risks

  • BEST: A double-blind placebo controlled study to evaluate the effects of bexaglifozin on hemoglobin A1c in patients with type 2 diabetes and increased risk of cardiovascular adverse events. Protocol number: THR-1442-C-476

    • Currently enrolling participants.
    • NCT: 02558296

Cardiac Catheterization/Stent trials/Cardiac Surgery/CRT-pacing trials

  • ENVISAGE: A multinational, multi-center, prospective, randomized, open label study with blinded evaluation of endpoints parallel group study comparing Edoxaban verses standard of care and their effects on clinical outcomes in patients with atrial fibrillation having undergone transcatheter aortic valve implantation. Protocol Number: DU176B-C-U4001.
    • Currently enrolling participants.
    • NCT: 02943785
  • GUARD: A multi-center, prospective, parallel group, double blind, randomized, placebo controlled, phase 2 study to assess the safety and efficacy of BB3 in patients developing acute kidney injury after cardiac surgery. Protocol Number: 002-15.
    • Currently enrolling participants.
    • NCT: 02771509
  • LEADERS FREE II: A prospective study of the BioFreedomTM Biolimus A9 TM Brug Coated Stent in Patients at high risk for bleeding.

    • Enrollment goal met, patients in follow-up only.
    • NCT: 02843633
  • QUARK: A Randomized, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Acute Kidney Injury in Subjects at High Risk for AKI following Cardiac Surgery.

    • Enrollment goal met, patients in follow-up only.
    • NCT: 02610283
  • REDUAL PCI: A prospective Randomised, open label, blinded endpoint (PROBE) study to Evaluate DUAL antithrombotic therapy with dabigatran etexilate (110mg and 150mg b.i.d.) plus clopidogrel or ticagrelor vs. triple therapy strategy with warfarin (INR 2.0 – 3.0) plus clopidogrel or ticagrelor and aspirin in patients with non valvular atrial fibrillation (NVAF) that have undergone a percutaneous coronary intervention (PCI) with stenting.

    • Enrollment goal met, patients in follow-up only.
    • NCT: 02164864