VOLtage-based Contrast Media AdaptatioN in Coronary Computed Tomography Angiography (VOLCANIC-CTA)

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Coronary Artery Disease; Cardiovascular Diseases

Treatments: Drug: Ultravist 370Mg I/Ml Solution for Injection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03179592

Pro00060805

Details and patient eligibility

About

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).

Enrollment: 120 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

120 participants in 1 patient group

Low-volume contrast media injection protocol

Description:

Patients will receive a low-volume contrast media (Ultravist 370Mg I/Ml Solution for Injection) injection protocol that is tailored to a specific tube voltage. Tube voltages will be automatically selected by the scanner to be used for the CCTA acquisition.

Treatment:

Drug: Ultravist 370Mg I/Ml Solution for Injection