VOLtage-based Contrast Media AdaptatioN in Coronary Computed Tomography Angiography

Coronary Artery Disease Clinical Trial

— VOLCANIC-CTA  

Official title:

VOLtage-based Contrast Media AdaptatioN in Coronary Computed Tomography Angiography (VOLCANIC-CTA): A Prospective Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03179592
• Other study ID #: Pro00060805
• Status: Completed
• Start date: March 22, 2017
• Est. completion date: February 11, 2019

Study information

• Verified date: February 2020
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to prospectively evaluate the effectiveness of low-volume contrast media (CM) injection protocols adapted to tube voltage in patients undergoing Coronary Computed Tomography Angiography (CCTA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 11, 2019
• Est. primary completion date: February 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Referred for a clinically indicated CCTA scan.

2. Subject must be 18 - 85 years of age.

3. Subject must provide written informed consent prior to any study-related procedures being performed.

4. Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria:

1. Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:

• By testing (serum or urine beta HCG) within 24 hours before study agent administration, or

• By surgical sterilization, or

• Post-menopausal, with minimum one (1) year history without menses.

2. Subject is chosen by the automated tube voltage selection algorithm (or adjusted by the technologist) to be scanned using a tube voltage that is not 70, 80, 90, 100, 110, 120, or 130 kV.

3. Subject is chosen by the automated tube voltage selection algorithm (or adjusted by the technologist) to be scanned using a tube voltage that has previously reached the maximum subject number (20 subjects per tube voltage).

4. Subject has an acute psychiatric disorder.

5. Subject is unwilling to comply with the requirements of the protocol.

6. Subject has previously entered this study.

7. Subject has an allergy against iodinated contrast agents or pharmaceutical stressors used in this study.

8. Subject has impaired renal function (creatinine > 1.5 mg/dl).

9. Subject is in unstable condition.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease

Intervention

Drug:
• Ultravist 370Mg I/Ml Solution for Injection
Reduced contrast-volume injection protocols based on patient specific tube voltage.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative assessment of image quality	This will be performed by two independent observers using a semi-quantitative rating scale of 1 - 5. Image quality will be graded on a five-point scoring system: 1 non-diagnostic; 2 limited diagnostic value; 3 adequate (presence of artifacts not limiting detection of luminal stenosis); 4 good; 5 excellent. Image quality assessments will be performed on both the investigative and control groups.	2 years
Primary	Quantitative assessment of image quality	Measurements and calculations will be performed by two independent observers who will be blinded to image acquisition parameters. Signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) will be measured for all images.	2 years
Secondary	Radiation dose of coronary CTA	Determine the radiation dose (mSv) associated with low-volume contrast injection CCTA protocols.	2 years