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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)
    • Enrollment goal met. Patients in follow-up only.
    • 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
  • OPTION: Comparison of Anticoagulation with Left Atrial Appendage Closure after AF Ablation
    The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation. (Opening December 2019)
    • Currently enrolling participants.
    • NCT: 03795298
  • QUARK 309: QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery.
    • Enrollment goal met.
    • NCT: 032510897
  • XIENCE 90 STUDY: Evaluate the safety of 3 month DAPT in subjects at high risk of bleeding undergoing PCI with Xience stent.
    • Enrollment goal met. Patients in follow-up only.
    • 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
    • Enrollment goal met. Patients in follow-up only.
    • NCT: 02525939
  • HERITAGE: Multi-center cross-sectional epidemiological study to characterize the prevalence and distribution of lipoprotein(a) levels among patients with established cardiovascular disease.

    • Currently enrolling participants.

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 Trials

  • QUIO: This single-blind, single-center, randomized, controlled trial is designed to evaluate the utility of the CRx Remote Care Solution in the management of subjects with T2D who are being treated with insulin glargine and metformin. The CRx Remote Care Solution comprises connected devices (InsulCheck, a Bluetooth-enabled pill bottle cap, and a Bluetooth-enabled glucometer), a mobile smartphone app (CRx App), an automated support system (Intervention Engine), and a remote care application (Care Module). (Opening by late November 2019)
    • NCT: 03997331

Electrophysiology Trials

  • ARTESIA: Apixaban for the Reduction of Thrombo-Embolism in patients with Device-Detected Sub-Clinical Atrial Fibrillation.
    • Currently enrolling participants.
    • NCT: 02840201
  • MORE CRT: MOre REsponse on Cardiac Resynchronization Therapy (CRT) with MultiPoint Pacing (MPP).
    • Enrollment goal met. Patients in follow-up only.
    • 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.
    • Currently enrolling participants.
    • NCT: 03473223
  • GOLDILOX: A Phase IIB, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction, Persistent Inflammation, and Elevated N-terminal Prohormone Brain Natriuretic Peptide.
    • Enrollment starting November 2020
    • NCT: Pending
  • ORESA: Outcome Research to Confirm the Anti-anginal Effect of T89 in Patients with Stable Angina
    This is a multi-center, double-blind, randomized, placebo-controlled, parallel-group phase 3 clinical study to confirm the safety and efficacy of T89 in patients with stable angina pectoris, with an extended open-label period to evaluate the long-term safety of T89.This study includes three main periods: the first study period is a 4-week single-blind qualifying period to screen eligible stable angina patients by exercise tolerance test (ETT). The second study period is a 8-week double-blind treatment period to evaluate the efficacy and safety of T89 in patients with stable angina by ETT. And the last study period is a 44-week open-label period to observe long-term use safety of T89.

    • Currently enrolling participants.
    • NCT: 03789552

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.
    • 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.
    • Enrollment goal met. Patients in follow-up only.
    • NCT: 03035474
  • DAPA-ACT HF: A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Trial to Evaluate the Effect of In-Hospital Initiation of Dapagliflozin on Clinical Outcomes in Patients with Heart Failure with Reduced Ejection Fraction Who Have Been Stabilized During Hospitalization for Acute Heart Failure.
    • Enrollment starts September 2020
    • NCT: 04363697
  • 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
    • Enrollment goal met. Patients in follow-up only.
    • NCT: 02929329
  • GUIDE-HF: Hemodynamic Guided Management of Heart Failure. The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including HF patients outside of the present indication, but at risk for future HF events or mortality.

    • Currently enrolling participants.
    • NCT: 03387813

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.
    • Enrollment goal met. Patients in follow-up only.
    • 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.