Coronary Artery Disease
Conditions
Brief summary
Coronary CT angiography is used to examine the coronary arteries in a non-invasive way when a patient is suspected of having coronary artery disease. The test, however, requires relatively high levels of radiation, which have been linked to DNA damage and cancer, and the use of contrast material, which can affect kidney function. The SOMATOM Force, a new third-generation CT scanner manufactured by Siemens, was recently installed at MUSC and holds the potential to obtain quality images while also reducing radiation dose and contrast material. This study aims to test the diagnostic ability of the SOMATOM Force in detecting coronary artery disease and also see if radiation dose and contrast material are reduced compared to the previous 2nd generation scanners. It is suspected that the Force will provide clinical quality images while decreasing radiation dose and contrast material required.
Interventions
PROCEDURECoronary CT angiography on SOMATOM Force
Coronary CT angiography using iodinated contrast; metoprolol and/or nitroglycerin may also be administered on a per-patient basis
PROCEDUREPrevious coronary CT angiography on 2nd generation CT scanner
Clinically indicated coronary CT angiography previously performed on a 2nd generation CT scanner
Sponsors
Medical University of South Carolina
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Subject must be between 18-90 years of age. * Subject must have been referred for a clinically indicated cardiac catheterization or nuclear cardiac perfusion study. * Subject must provide written informed consent prior to any study-related procedures being performed. * Subject must be willing to comply with all clinical study procedures.
Exclusion criteria
* Subject is a pregnant or nursing female. Exclude the possibility of pregnancy: * By testing (urine βHCG) within 24 hours before contrast agent administration, or * By surgical sterilization, or * Post menopausal, with minimum one (1) year history without menses. * Subject has an acute psychiatric disorder or is cognitively impaired. * Subject is using or is dependent on substances of abuse. * Subject is unwilling to comply with the requirements of the protocol. * Subject has decreased renal function (eGFR \<45) * Subject has an allergy against iodinated contrast agents. * Subject is in acute unstable condition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation dose and contrast material | one year | To determine the potential for reductions in radiation dose and contrast material requirements by performing coronary CT angiography at low tube potential with the new CT system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy | one year | To determine the diagnostic accuracy of coronary CT angiography performed with the new CT system using coronary catheterization or nuclear myocardial perfusion imaging as reference standards. |
Countries
United States
Outcome results
None listed