University of North Carolina of Chapel hill
Chapel Hill, North Carolina, 27599-7510, United States
NCT Number: NCT03169062
The purpose of this study is to propose a new method for evaluating coronary artery calcium scores (CACS) in individuals with coronary artery disease.
Looking for future studies?
Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Chapel Hill, North Carolina, 27599-7510, United States
The proposed research, if successfully implemented, will result in a new method for evaluating coronary artery calcium scores (CACS) in individuals with coronary artery disease. Using the Cardiac Gated Stationary Chest Tomosynthesis (CG-SDCT) system the imaging dose for a a full tomosynthesis scan is expected to be only 10% of that from a low-dose CT. The targeted imaging time of 25-30 seconds is 1/2 of that from a current commercial DCT system at the same imaging dose. As with current commercial DCT systems, our s-DCT system will expose patients to less radiation and deliver comparable data for CACS. CG-SDCT will likely result in accurate CAC scoring and allow for a more complete patient risk assessment as compared to Framingham risk scoring alone.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The technologist will comfortably position the patient laying face up on the imaging table. EKG leads will be placed in appropriate positions to derive an EKG signal. The EKG will be used to trigger the image collection. The subject will be asked to hold his or her breath for 25-30 seconds during the scan. Total patient preparation and imaging time should not exceed 20 minutes.
Time frame: 1 year
Linear regression and Bland-Altman analysis will be used to examine the relationship between the CT derived CACS and tomosynthesis scores to determine the correlation
Time frame: At the conclusion of all data collection, 6 months post study completion
The 30 ms cardiac EKG trace will be extracted for each of the projections. Then, a Pearson correlation coefficient will be calculated for each of the projections relative to the first x-ray projection. The mean of the Pearson correlation coefficients will then calculated and served as an estimate of the timing precision of each projection set for each patient. The mean and standard deviation of the correlation coefficients will be reported.
University of North Carolina, Chapel Hill
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03188705
Arterial Occlusive Diseases, Arteriosclerosis
Lancaster, Pennsylvania, United States
View Trial DetailsNCT07468955
Arterial Occlusive Diseases, Arteriosclerosis
Kütahya, Center, Turkey (Türkiye)
View Trial DetailsNCT06029517
Arterial Occlusive Diseases, Arteriosclerosis
Buffalo, New York, United States
View Trial DetailsNCT04058990
Arterial Occlusive Diseases, Arteriosclerosis
Kitakyushu, Fukuoka, Japan
View Trial Details