Frequently Asked Questions
What are clinical studies?
Clinical studies are a way to learn about and develop new treatments and medications for diseases and conditions. There are strict rules and guidelines for clinical studies. The National Institutes of Health and the U.S. Food and Drug Administration monitor the conduct of the studies.
Why should I participate?
Advances in science and technology have been possible by the willingness of thousands of individuals like you to participate in clinical studies. This study may not make your health better. However, information learned in this trial will help to better care for patients with asymptomatic carotid disease in the future.
How long will I be in this study?
You will be in the study for up to four years.
What are my rights if I choose to participate in this study?
Taking part in this research study will not change your rights and benefits. Taking part in this research study does not give you any special privileges. If you decide to not participate in this study, or stop in the middle of the study, no benefits are taken away from you. You do not have to be in this research study to receive or continue to receive medical care.
You will be told of important new finds or any changes in the study procedures that may affect you or your willingness to continue in the study.
Will I need to pay for any of the tests, procedures, and medications?
You and/or your health plan will need to pay for all tests and procedures that are part of this study, including carotid endarterectomy or carotid artery stenting, and the blood tests to monitor your risk factors because they are part of regular medical care for patients with carotid artery disease. If your insurance does not cover the costs of the blood pressure and cholesterol medications required by this study to control your vascular risk factors, then the study will provide these medications at no additional cost to you.
The INTERVENT lifestyle program will be provided to you by the study free of charge whether you have health insurance or not.
Will I be paid for participating in this research study?
You will receive $95 for each scheduled visit you complete. These scheduled visits include the baseline visit, and the subsequent visits at 44-days, 4-months, 8-months, and then at 12-months, 18-months, 24-months, 30-months, 36-months, 42-months, and 48-months. You will be paid following each visit.
What is randomization?
Randomization is when two or more alternative treatments are selected by chance, not by choice. The treatment chosen is given with the highest level of professional care and expertise, and the results of each treatment are compared.
There are three treatment methods in CREST-2:
Who will decide which procedure I will receive?
The methods for opening the carotid artery include carotid endarterectomy or carotid artery stenting. The study team will discuss the benefits and risks of each treatment with you. You and your treating doctor will then decide which procedure would be the best option to open your carotid artery.
After you have decided which procedure is the best method for you, you will be put in one of the following groups by chance (randomized):
You will have a 1 out of 2 chance of being in either group. Neither you nor your doctor will be able to choose which group you are placed into.
What does intensive medical management involve?
All study participants will undergo intensive medical management.
You will have blood tests to evaluate your risk factors for stroke.
You will take a regular strength aspirin table (325 mg) once a day.
You may take other medications to control various risk factors such as high blood pressure or high cholesterol.
The study doctor will also work with your primary care doctor on a program for weight loss, smoking cessation, exercise, and diabetes management, depending on your individual health needs.
You will also be enrolled in a risk factor management program called INTERVENT. This is a program that is used around the country and in other parts of the world that helps patients manage their risk factors.
Help in managing your risk factors will be done through telephone calls with one of the INTERVENT staff members. These staff members, or coaches, are healthcare workers who are not physicians. These coaches have been specially trained to follow the medical management plan your study doctors have recommended for you and help you figure out ways to follow them as completely as possible.
What other choices do I have if I don’t take part in this research study?
You do not have to be in this study to receive treatment for your condition. Your other choices may include other procedures or medications which will be discussed by the physician with you. You should talk to the researcher and your regular physician about each of your treatment options before you decide if you will take part in this study.