About the Study

Kalamazoo area physicians are invited to refer patients to an observational study being conducted through the Center for Clinical Research at the Western Michigan University Homer Stryker M.D. School of Medicine.

Research clinical investigators are seeking 500 participants over the next three years, between the ages of 35 and 55 who will receive tests including Coronary Computed Tomography (CCTA), a Coronary Artery Calcium Score and a blood draw.

Dr. Vishal Gupta is the principal investigator. Conducted in cooperation with Borgess, KNI/Southwest Michigan Imaging Center, Premier Radiology, Western Michigan University, and Genemarkers, LLC, the study focuses on individuals who are not experiencing coronary disease symptoms.

The study may be used to expand the guidelines for assessing the presence of undiagnosed asymptomatic coronary artery disease. It will also look at markers, including genetic biomarkers that could be helpful in diagnosis.

The name of the clinical study is “Evaluation of Asymptomatic Coronary Atherosclerotic Disease among people in Kalamazoo, Michigan.”

Study Procedures

After signing the consent form, participants will be given an identifying number that will be used, along with their initials, on all documents in the study. Lab results and other documents will be de-identified and stored in their research charts. If permission is given by the study subjects, study results will be made available to the referring physician/PCP.

Blood work will be done, and if the GFR is less than 45 the participant will not be eligible for this study. Female subjects that can become pregnant will be given a pregnancy test. Subjects cannot be pregnant or lactating when participating in this study. Subjects’ medical history will be reviewed and will search for exclusionary items. The WHO questionnaire will be given to the subjects to assess asymptomatic response. All participants will be reviewed to assess if subject can participate in the study.

Those subjects who may participate in the study will enroll in KNI Southwest Michigan Imaging Center for the CCTA. Medical history and current medications will be reviewed again by KNI. KNI will obtain written consent for CCTA and will be performed standardly.

A follow up phone call will be placed for all participants to measure overall satisfaction with the study and procedure. Each diagnosed participant will also be given an evaluation for lifestyle changes.