Purpose of this Study
In the TRANSFORM study, the study team will check your medical history and the medicines you take. They will measure your height, weight, blood pressure, and waist size. If your recent lab results are not in your medical record, you will give a fasting blood sample so doctors can check things like cholesterol, blood sugar, liver and kidney function, and signs of inflammation. You will be told the results of these regular lab tests. Another blood sample will be saved for future research to learn more about heart disease, including tests on your DNA, but you will not get the results from those future tests. The study team will tell you if your test results fall within the range needed to join the study. If they do, you will have a special heart scan called a coronary CT.
Who Can Participate?
Eligibility
People can join this study if they have given permission in writing or online. Men must be older than 55 and women must be older than 65. They must have at least one health condition such as type 2 diabetes, prediabetes, or metabolic syndrome. Metabolic syndrome means having several health problems like a high BMI, a large waist, high triglycerides, low HDL cholesterol, high blood pressure, or high blood sugar. People must also have a device like a smartphone, tablet, or computer so they can communicate with the study team.
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 see which type of care works better at lowering the chance of heart problems. One type of care is based on the Cleerly CAD stage, which uses pictures of the heart to guide treatment. The other type of care uses a persons risk factors, like high blood pressure or high cholesterol. The study will also look at other health outcomes, such as kidney and heart problems and deaths. Researchers will check how safe each type of care is and if either one causes any harms.
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