"State-of-the-Heart" Research Program
MCVI has one of the largest cardiovascular disease research programs in the Midwest. Our team of cardiologists, electrophysiologists and cardiovascular surgeons conduct nationally recognized drug and device studies to promote advances in diagnosis, treatment, and prevention of cardiovascular diseases.
Currently MCVI is involved in numerous research protocols and trials at the following hospitals: St. Mary's of Michigan, Covenant HealthCare, MidMichigan Medical Center-Midland and certain MCVI offices in Central and Northeastern Michigan, as well as the Thumb Area. Through research we are able to bring new cutting edge technologies to our physicians and the community.
MCVI's Research Coordinators
Katie Mostek, RN, of Bay City, leads Michigan CardioVascular Institute's research team as Clinical Director. Her responsibilities are to coordinate cardiovascular research related to investigational new drugs and devices initiated by MCVI. She is a graduate of Delta College and has more than 38 years of experience in nursing.
Peter G. Fattal, MD serves as the Medical Director for Michigan CardioVascular Institute's Research program. He is responsible for oversight of all research protocols conducted within the MCVI program.
Each study is assigned a Principal Investigator and assorted sub-investigators. The principal investigator is an individual under whose immediate direction the test article is administered or dispensed to a participant. The principal investigator must be a licensed MD, DO, or DDS with qualified training and must ensure that the investigation is conducted according to the investigational plan.
Each site has an Institutional Review Board which is a committee formally designated by a medical center to review biomedical research involving human participants. Central Institutional Review Boards may also be used for outpatient studies.
Study Phases for Drug Trials
The clinical testing of investigational drugs is normally done in three phases. Once the FDA has granted a New Drug Approval or New Device Indication the sponsor company may conduct post-marketing or late phase III or IV studies.
Phase I - Studies a drug's safety profile.
Phase II - Small, well-controlled trials to evaluate drug safety and efficacy; assesses side effects.
Phase III - Verifies effectiveness, monitors adverse reactions from long term use.
Phase IV - Post market analysis; Evaluates the drug's safety during routine use.
To see a list of our current studies with their inclusion and exclusion information click here.
For more information on research studies, please click here.
For more information on the CISCRP (The Center for Information and Study on Clinical Research Participation), please click here.
If you have any questions and/or if you have questions about a patient that states they are currently enrolled in a research trial, please do not hesitate to notify us. This enables us to continue to collect required data and be sure programming requirements are maintained per study protocol. You can reach our Research Department by calling (989) 754-3555 ext. 4187 or toll-free 1-877-725-6284 ext. 4187.