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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 Clinical Research Department.

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 Clinical 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.

MidMichigan Cardiovascular Current Clinical Trials

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

  • ENVISAGE TAVI Afib: Edoxaban versus standard of care and their effects on clinical outcomes in patients having undergone Transcatheter aortic valve implantation –in atrial fibrillation. (3 Randomized)
    • Currently enrolling participants.
    • NCT: 02943785
  • GUARD: A multicenter, prospective, parallel-group, double-blind, randomized, placebo-controlled, Phase 2 Study of BB3 to Assess the Safety and Efficacy of BB3 in patients developing acute Kidney Injury after Cardiac Surgery. (9 Screened, 6 randomized)
    • 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
  • QUARK 309: QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery. (0 enrolled)
    • Currently enrolling participants.
    • NCT: 032510897
  • XIENCE 90 STUDY:  Evaluate the safety of 3 month DAPT in subjects at high risk of bleeding undergoing PCI with Xience stent. (17 screen fail, 3 enrolled)
    • Currently enrolling participants.
    • NCT: 03218787

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 with 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.

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

Electrophysiology Trials

  • ARTESIA: Apixaban for the Reduction of Thrombo-Embolism in patients with Device-Detected Sub-Clinical Atrial Fibrillation. (Opened 3/2018, 2 enrolled)
    • Currently enrolling participants.
    • NCT: 02840201
  • MORE CRT: MOre REsponse on Cardiac Resynchronization Therapy (CRT) with MultiPoint Pacing (MPP). (Opening 4/30/19)
    • Currently enrolling participants.
    • NCT: 02006069

Heart Attack/Myocardial Infarction

  • AEGIS II: A Phase 3 multicenter, double blind, randomized, placebo controlled, parallel group study to evaluate the safety of CLS112 ( a apolipoprotein ApoA-1) on reducing the risk of MACE in subjects with ACS. (4 enrolled)
    • Currently enrolling participants.
    • NCT: 03473223

Heart Failure Trials

  • ARRAY: This is a phase 3, multinational, randomized, placebo controlled study of Arry-371797 In patients with symptomatic dilated cardiomyopathy due to a Lamin A/C Gene Mutation. (3 screened, 0 enrolled)
    • Currently enrolling participants.
    • NCT: 03439514
  • CONNECT-HF: Care OptimizatioN through PatieNt and Hospital Engagement Clinical Trial for Heart Failure.  Inpatient HF with EF<40% with smart phone downloads engaging App and assessed for outcomes and QOL through 12 months. (10 enrolled)
    • Currently enrolling participants.
    • NCT: 03035474
  • GLACTIC-AMG 423: Safety and efficacy of Omecamtiv mecarbil on mortality and morbidity of patients with EF < 35%. HF Hospitalization within 12 months. (4 Screened, 2 randomized)
    • Currently enrolling participants.
    • NCT: 02525939
  • 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

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

Participate in a Clinic Research Trail

To participate in Clinical Research Trial, please call our office at (989) 631-2469 or email us at cvresearch@midmichigan.org.