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. MyMichigan Health is a part of that process in the Clinical Research Department.
MyMichigan 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 MyMichigan 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 MyMichigan Health institutional Review Board also oversees all aspects of research done locally.
As “medical heroes” throughout the Great Lakes Bay Region, MyMichigan 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.
MyMichigan Cardiovascular Current Clinical Trials
Cardiac Catheterization/Stent trials/Cardiac Surgery/CRT-pacing Trials
- OPTION - Dr. Islam
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.
REN-004 - Dr. Collar
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing Coronary Artery Bypass Graft (CABG) and/or Cardiac Valve Surgery (The START Study).
Cardiovascular Disease Trials
- WARRIOR - Dr. Showole
Women’s Ischemia trial to reduce events in non-obtructive CAD A prospective randomized, blinded outcome evaluation of intensive Med therapy (ACE/Statin/ASA) vs usual care in 4422 symptomatic women with ischemia but no obstructive CAD.
- Victorion (V2P) - Dr. Boguszweski
A Randomized, Multicenter, Open-label Trial Comparing the Effectiveness of an "Inclisiran First" Implementation Strategy to Usual Care on LDL Cholesterol (LDL-C) in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C (≥70 mg/dL) Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE).
- ARTESIA - Dr. Islam
Apixaban for the Reduction of Thrombo-Embolism in patients with Device-Detected Sub-Clinical Atrial Fibrillation.
Heart Attack/Myocardial Infarction
- AEGIS II - Dr. Felten
CSL112-3001: A Phase 3 multicenter, double blind, randomized, placebo controlled, parallel group study to investigate the efficacy and safety of CSL112 in subjects with Acute Coronary Syndrome (ACS).
- EMPACT - Dr. Felten
EMPACT-MI: A Streamlined, Multicenter, Randomized, Parallel Group, Double-blind Placebo-controlled Superiority Trial to Evaluate the Effect of EMPAgliflozin on Hospitalization for Heart Failure and Mortality in Patients With aCuTe Myocardial Infarction.
- GOLDILOX: MEDI6590 - Dr. Lauer
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.
SOS-AMI - Dr. Doghmi
Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Self-administered Subcutaneous Selatogrel for Prevention of All-cause Death and Treatment of Acute Myocardial Infarction in Subjects With a Recent History of Acute Myocardial Infarction.
Heart Failure Trials
- ARRAY - Dr. Martindale
ARRAY 797-301: 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.
- DAPA-ACT HF - Dr. Boguszewski
Brigham and Women's Hospital/TIMI Study Group: 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.
GUIDE-HF - Dr. Martindale
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.
New clinical trials are available often. Please contact the Clinical Research Department at (989) 631-2469 or by email at email@example.com for more details.