Coronary CT Angiography Using a Novel 3rd Generation Dual-Source CT System



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 90
Updated:5/4/2018
Start Date:January 2014
End Date:November 2017

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Coronary CT Angiography Using a Novel 3rd Generation Dual-Source CT System: Diagnostic Performance and Potential for Reduction in Radiation Dose and Contrast Material Requirement

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.


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.
We found this trial at
1
site
Charleston, South Carolina 29401
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Charleston, SC
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