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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Medical University of South Carolina
Sponsor:
Information provided by (Responsible Party):
U. Josepf Schoepf, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT02218060
First received: August 14, 2014
Last updated: NA
Last verified: August 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Procedure: Coronary CT angiography on SOMATOM Force
Procedure: Previous coronary CT angiography on 2nd generation CT scanner

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Radiation dose and contrast material [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: January 2014
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02218060

Contacts
Contact: Stephen R Fuller, BS 843-876-4922 fullerst@musc.edu

Locations
United States, South Carolina
MUSC Ashley River Tower Recruiting
Charleston, South Carolina, United States, 29401
Principal Investigator: U. Joseph Schoepf, MD         
Sponsors and Collaborators
U. Josepf Schoepf, MD
Investigators
Principal Investigator: U. Joseph Schoepf, MD MUSC
  More Information

No publications provided

Responsible Party: U. Josepf Schoepf, MD, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02218060     History of Changes
Other Study ID Numbers: Force Cardiac
Study First Received: August 14, 2014
Last Updated: August 14, 2014
Health Authority: United States: MUSC IRB
United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014