VOLtage-based Contrast Media AdaptatioN in Coronary Computed Tomography Angiography



Status:Recruiting
Conditions:Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:10/20/2018
Start Date:March 22, 2017
End Date:December 31, 2019
Contact:Dante A Giovagnoli, MS
Email:Giovagnd@musc.edu
Phone:843-876-4922

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

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).


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.
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: U. Joseph Schoepf, MD
Phone: 843-876-4922
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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