VOLtage-based Contrast Media AdaptatioN in Coronary Computed Tomography Angiography

Completed

• Conditions: Coronary Artery Disease; Cardiovascular Diseases
• Interventions: Drug: Ultravist 370Mg I/Ml Solution for Injection

• Registration Number: NCT03179592
• Lead Sponsor: Medical University of South Carolina

Brief 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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-03-22
• Study First Submitted: 2017-06-01
• Study First Submitted QC: 2017-06-05
• Study First Posted: 2017-06-07
• Primary Completion: 2019-02-11
• Study Completion: 2019-02-11
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low-volume contrast media injection protocol	Ultravist 370Mg I/Ml Solution for Injection	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.

Primary Outcome Measures

Name	Time	Method
Qualitative assessment of image quality	2 years	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.
Quantitative assessment of image quality	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Radiation dose of coronary CTA	2 years	Determine the radiation dose (mSv) associated with low-volume contrast injection CCTA protocols.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States