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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02218060
• Other study ID #: Force Cardiac
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: November 2017

Study information

• Verified date: April 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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 ßHCG) 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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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
• Previous coronary CT angiography on 2nd generation CT scanner
Clinically indicated coronary CT angiography previously performed on a 2nd generation CT scanner

Locations

Country	Name	City	State
United States	MUSC Ashley River Tower	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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