This study will look at two ways to prevent heart and blood vessel problems. It will test which treatment works better for people who may have hidden artery disease because of conditions like diabetes or metabolic syndrome. One way uses your risk factors, and the other way uses pictures of your heart arteries to guide care.
Atherosclerosis happens when the arteries that carry blood to your heart, brain, and other parts of your body become narrow and stiff because of plaque build-up. This can lead heart disease, which is the number one cause of death in the world. You are invited to join this study because you have risk factors for atherosclerosis like diabetes, prediabetes, or metabolic syndrome. If you choose to join, you will meet with the study team to go over your medical history. They will also measure your height, weight, blood pressure, and waist size. If you do not have recent lab results, you will have a fasting blood test to check cholesterol, blood sugar, and other routine health markers. You will get these results. You can also choose to give a second blood sample for future research. You will not get the results from the second sample. If you qualify for the study, you will have a heart CT scan, a blood test to check your kidneys, and you will fill out a health survey. The CT scan uses a special X-ray and dye to take pictures of the arteries in your heart. After the scan, you will be randomly placed, like flipping a coin, into one of two groups that use different ways to prevent or slow artery disease. You will not get to choose your group. If you are in the risk factor group, you will keep seeing your regular doctor and follow current treatment guidelines for your risk factors. If you are in the other group, your CT scan will be checked using a special computer program to see how much and what kind of atherosclerosis you have. A heart doctor (cardiologist) will figure out your risk of a heart attack or other heart problems and work with your doctor to create the best treatment plan for you. The study team will check in on you at 3 and 6 months, and then every 6 months until the end the study ends. You will have another heart CT scan at 2 years. The study is about 3 ½ years but could last up to 5 years. After you finish, the study team may look at your health records for up to 10 years. You will get $80 for each visit you complete.
You may be able to join if you are a man over 55 or a woman over 65. You must have diabetes, prediabetes, or have been told you have metabolic syndrome. Metabolic syndrome means you have several health problems, like extra belly weight, high triglycerides, low HDL (“good”) cholesterol levels, high blood sugar, or high blood pressure. You also need a phone, tablet, or computer to talk with the study team. You cannot join if you have ever had a heart attack, stroke, or lost a toe, foot, or leg. You also cannot join if you have had a heart stent, bypass surgery, or surgery/stents in blood vessels in your legs or neck. People with ongoing chest pain, leg pain when walking, or other symptoms your doctor has tested for heart or blood vessel disease in the past year cannot join.
Protocol Number: 23-1852
Principal Investigator