Purpose of this Study
In the TRANSFORM study, the team will look at 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 after you have not eaten for a while. This blood will be tested for things like cholesterol, blood sugar, liver and kidney health, and signs of inflammation. You will get these results.
Another blood sample will be saved for future research to learn more about heart disease and to study your DNA. You will not get results from these future tests. 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, a person must agree in writing or electronically. Men must be older than 55 years, and women must be older than 65 years. They also need to 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, having high blood pressure, high blood sugar, high triglycerides, or low good cholesterol.
People also need to have a phone, tablet, or computer so they can talk with the heart doctor team if they are in the group that uses the Cleerly CAD care plan.
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
This study wants to see which way of caring for people is better at lowering the chance of heart problems. One way uses a test called Cleerly CAD to look at the stages of heart disease. The other way uses risk factors like blood pressure or cholesterol. The study will also check other health results, like problems with the heart or kidneys, and how many people live or die. Finally, it will look at how safe each care plan is and if there are 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