Purpose of this Study
In the TRANSFORM study, the team will check your medical history and medicines. They will measure your height, weight, blood pressure, and waist size. If your recent lab results are not in your records, they will take a blood sample to check things like cholesterol, blood sugar, liver and kidney health, and inflammation. You will get these results. Another blood sample will be saved for future research to learn more about heart disease and your DNA, but you will not get those results. If your numbers are in the right range, you will have a special heart scan called a coronary CT.
Who Can Participate?
Eligibility
To join this study, people must agree to take part and sign a consent form. Men must be older than 55, and women must be older than 65. They must have at least one health problem, such as type 2 diabetes, prediabetes, or metabolic syndrome. Metabolic syndrome means having three or more issues like being overweight, high triglycerides, low good cholesterol, high blood pressure, or high blood sugar. People also need a smartphone, tablet, or computer to talk with the heart care team if they are in the special care group.
Age Range
3-5
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The study wants to find out if a new way of caring for the heart, called Cleerly stage-based care, can lower the chances of heart problems better than the usual care based on risk factors. It will also compare how each care plan affects other health problems, like heart and kidney issues, and how long people live. The study will check if either care plan has any risks or harmful effects.
Locations
Duke University Hospital
Pickett Road Research
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
A Randomized Comparison of Cleerly Coronary Artery Disease Stage-Based Care Versus Risk Factor-Based Care for Primary Prevention of Cardiovascular Events
Principal Investigator
William
Yancy
Protocol Number
PRO00117568
Enrollment Status
Open to Enrollment