VOLtage-based Contrast Media AdaptatioN in Coronary Computed Tomography Angiography

NCT03179592 | Completed FDA Drug

• 1 other identifier: Pro00060805
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Disease; Cardiovascular Diseases

Keywords

Computed Tomography

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Radiation dose of coronary CTA

  2 years

Study Arms (1)

Low-volume contrast media injection protocol

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.

Drug: Ultravist 370Mg I/Ml Solution for Injection

Interventions

Ultravist 370Mg I/Ml Solution for Injection DRUG

Reduced contrast-volume injection protocols based on patient specific tube voltage.

Also known as: Iopromide

Low-volume contrast media injection protocol

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes 120 patients who present to radiology department for clinically indicated CCTA scan. In order to be included patients must meet all inclusion criteria and none of the exclusion criteria.

You may qualify if:

• Referred for a clinically indicated CCTA scan.
• Subject must be 18 - 85 years of age.
• 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 (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.
• 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.
• 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).
• Subject has an acute psychiatric disorder.
• Subject is unwilling to comply with the requirements of the protocol.
• Subject has previously entered this study.
• Subject has an allergy against iodinated contrast agents or pharmaceutical stressors used in this study.
• Subject has impaired renal function (creatinine \> 1.5 mg/dl).
• Subject is in unstable condition.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Bayer: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Cardiovascular Diseases

Interventions

iopromide; Injections

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 7, 2017
• Study Start: March 22, 2017
• Primary Completion: February 11, 2019
• Study Completion: February 11, 2019
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)