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Completed

NCT Number: NCT03179592

VOLtage-based Contrast Media AdaptatioN in Coronary Computed Tomography Angiography

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).

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Ultravist 370Mg I/Ml Solution for Injection

Drug

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

Other names: Iopromide

Primary outcomes

  1. Qualitative assessment of image quality

    Time frame: 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.

  2. Quantitative assessment of image quality

    Time frame: 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 outcomes

  1. Radiation dose of coronary CTA

    Time frame: 2 years

    Determine the radiation dose (mSv) associated with low-volume contrast injection CCTA protocols.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Bayer

Registry information

Official study title

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

Acronym: VOLCANIC-CTA

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 7, 2017
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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