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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coronary CT angiography on SOMATOM Force
Previous coronary CT angiography on 2nd generation CT scanner
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • MUSC Ashley River Tower

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Force

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 14, 2014
Last Updated
April 30, 2018
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT02218060
Brief Title
Coronary CT Angiography Using a Novel 3rd Generation Dual-Source CT System
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Force
Arm Type
Experimental
Arm Description
Patients receiving coronary CT angiography on the SOMATOM Force before clinically indicated cardiac catheterization or after clinically indicated nuclear stress test
Arm Title
Control
Arm Type
Other
Arm Description
Patients who have already received comparable CT examinations on current routine 2nd generation dual-source CT systems
Intervention Type
Procedure
Intervention Name(s)
Coronary CT angiography on SOMATOM Force
Intervention Description
Coronary CT angiography using iodinated contrast; metoprolol and/or nitroglycerin may also be administered on a per-patient basis
Intervention Type
Procedure
Intervention Name(s)
Previous coronary CT angiography on 2nd generation CT scanner
Intervention Description
Clinically indicated coronary CT angiography previously performed on a 2nd generation CT scanner
Primary Outcome Measure Information:
Title
Radiation dose and contrast material
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Diagnostic accuracy
Description
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.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
U. Joseph Schoepf, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
MUSC Ashley River Tower
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States

12. IPD Sharing Statement

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

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