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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Coronary CT angiography on SOMATOM Force; Procedure: Previous coronary CT angiography on 2nd generation CT scanner

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • MUSC Ashley River Tower

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Force; Patients receiving coronary CT angiography on the SOMATOM Force before clinically indicated cardiac catheterization or after clinically indicated nuclear stress test	Procedure: Coronary CT angiography on SOMATOM Force; Coronary CT angiography using iodinated contrast; metoprolol and/or nitroglycerin may also be administered on a per-patient basis
Other: Control; Patients who have already received comparable CT examinations on current routine 2nd generation dual-source CT systems	Procedure: Previous coronary CT angiography on 2nd generation CT scanner; Clinically indicated coronary CT angiography previously performed on a 2nd generation CT scanner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation dose and contrast material	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.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy	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.	one year

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: U. Joseph Schoepf, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: August 14, 2014
• First Submitted That Met QC Criteria: August 14, 2014
• First Posted (Estimate): August 15, 2014

Study Record Updates

• Last Update Posted (Actual): May 2, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: Force Cardiac