The purpose of this research study is to determine whether physicians can safely
provide more rapid diagnosis of the cause of your chest pain, using non-invasive CT scanning of the coronary arteries. Cardiac CT, using the newest scanners, is an improved way of looking at the coronary arteries, which supply blood to the heart muscle. If these arteries are clogged this may cause chest pain or even a heart attack. The images of the coronary arteries obtained by CT scanners during a 5-10 minute procedure) have been shown by many studies to be accurate, when compared to the conventional invasive cardiac catheterization procedure.
Prior studies done at several different hospitals have shown that CT scanning is as
accurate and cost-effective as the "usual" emergency room testing procedures, which may include cardiac nuclear rest-stress scans. This research study will take place at multiple hospitals at the same time. This is part of the process that medical advances must go through to become a part of the routine care of patients throughout the country.
Eligible patients are those who come to the Emergency Department at Cedars-Sinai, and:
- Are referred for a clinical stress SPECT, stress PET, CTA, or PET-CT study
- Have an intermediate to high pretest likelihood for heart disease without prior heart attack or cardiac revascularization;
- Have documented prior history of heart disease as defined by a history of prior heart attack, coronary revascularization, or cardiac catheterization with evidence of heart disease;
- Does not meet exclusion criteria; and
- Provide signed informed consent to participate in the study.
This is a randomized research study. "Randomized" means that you will be assigned to a study group by chance, like flipping a coin. You will be randomized into one of two study groups, and will have an equal chance of being placed in (either/any) of the two groups. Both groups will receive a routine initial diagnostic evaluation, including a history and physical exam, laboratory work and electrocardiogram (EKG). After the initial evaluation, you will be asked to sign informed consent and you will be randomized to receive either a "rest-stress" cardiac nuclear scan (the standard care for your diagnosis) or a cardiac CT scan (the study procedure). It is important that you realize that only half of the patients will have a CT
scan and you may not be assigned to that group.
If you are assigned to the CT group, the scan will be done in the early part of your Emergency Department (ED) stay. If you are randomized to the non-CT group, you will have a standard rest/stress nuclear scan in which an image of your heart is taken at rest and compared to an image taken hours later while the heart is stressed, typically achieved through medication.
Further screening laboratory tests may be required, including a pregnancy test if
appropriate and a kidney function test in CT Scan Group patients, if not taken as part of your standard diagnostic testing, to ensure you meet all inclusion criteria for the study. In all cases, your health is the major priority of the medical staff and researchers of this study, and if necessary, your participation will be stopped if it is not in your best interest to continue. At any point, you may change your mind about being a participant in this study. That is perfectly acceptable and will NOT affect your care.
After discharge from the hospital, we will collect follow-up information from you, your hospital and your physicians through telephone conversation and review of
medical records at one month and six months. You will be asked questions regarding your cardiac health and medications you have been taking since you were originally seen in the ED. This short (less than 5 minutes) follow up is to assess for any health problems you may have experienced since being discharged
from the hospital.
| Nancy Zambrana |
| Study Coordinator |
| Phone: (310) 423-3763 |
| Fax: (310) 423-8396 |
| Send Us a Message |
