Coronary CT Angiography Using a Novel 3rd Generation Dual-Source CT System
1 other identifier
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Jan 2014
Typical duration for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 14, 2014
CompletedFirst Posted
Study publicly available on registry
August 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedMay 2, 2018
April 1, 2018
3.8 years
August 14, 2014
April 30, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Diagnostic accuracy
one year
Study Arms (2)
Force
EXPERIMENTALPatients receiving coronary CT angiography on the SOMATOM Force before clinically indicated cardiac catheterization or after clinically indicated nuclear stress test
Control
OTHERPatients who have already received comparable CT examinations on current routine 2nd generation dual-source CT systems
Interventions
Coronary CT angiography using iodinated contrast; metoprolol and/or nitroglycerin may also be administered on a per-patient basis
Clinically indicated coronary CT angiography previously performed on a 2nd generation CT scanner
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MUSC Ashley River Tower
Charleston, South Carolina, 29401, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
U. Joseph Schoepf, MD
Medical University of South Carolina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 14, 2014
First Posted
August 15, 2014
Study Start
January 1, 2014
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
May 2, 2018
Record last verified: 2018-04