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

NCT ID: NCT02218060

Last Updated: 2018-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-11-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Force

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

Group Type: EXPERIMENTAL

Coronary CT angiography on SOMATOM Force

Intervention Type: PROCEDURE

Coronary CT angiography using iodinated contrast; metoprolol and/or nitroglycerin may also be administered on a per-patient basis

Control

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

Group Type: OTHER

Previous coronary CT angiography on 2nd generation CT scanner

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Previous coronary CT angiography on 2nd generation CT scanner

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

U. Joseph Schoepf, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

U. Joseph Schoepf, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

MUSC Ashley River Tower

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

Force Cardiac

Identifier Type: -

Identifier Source: org_study_id