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

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Procedure: Coronary CT angiography on SOMATOM Force; Procedure: Previous coronary CT angiography on 2nd generation CT scanner

Study type: Interventional

Funder types: Other

Identifiers

NCT02218060

Force Cardiac

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Force

Experimental group

Description:

Patients receiving coronary CT angiography on the SOMATOM Force before clinically indicated cardiac catheterization or after clinically indicated nuclear stress test

Treatment:

Procedure: Coronary CT angiography on SOMATOM Force

Control

Other group

Description:

Patients who have already received comparable CT examinations on current routine 2nd generation dual-source CT systems

Treatment:

Procedure: Previous coronary CT angiography on 2nd generation CT scanner