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Completed

NCT Number: NCT02840903

A Non-interventional Study to Observe the Computed Tomographic Angiography Image Quality With Different Contrast Media Injection Protocols Under Different Computed Tomography Machines Parameters Setting

The objective of this study is to evaluate the image quality for different iodine delivery rates at different low voltage scanning protocols (80 or 100 kV ) under the modern advanced Multi-Detector Computed Tomography (MDCT) considering the body weight of patients.

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Key information

Conditions

Angiography Multidetector Computed Tomography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, China

About this study

The purpose of this study is to evaluate the image quality of different acquisition protocols in patients weighing less than 90 kg using low voltage 80 or 100 kV with a lower Iodine Delivery Rate based on the body weight of the patient, who will undertake coronary or craniocervical CTA (Computed Tomography Angiography) in routine procedures.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients for whom the decision to initiate CTA will be made as per investigator's routine practice.
  • Adult patients (age ≥18 years) with a weight ≤ 90 kg.
  • Written Informed Consent.

Exclusion criteria

  • A history of hypersensitivity to iodinated contrast agents.
  • Known or suspected hyperthyroidism or pheochromocytoma.
  • Atrial fibrillation or any other cardiac arrhythmia that would preclude reliable ECG gating; have severe congestive heart failure (New York Heart Classification IV).
  • Pregnant or lactating women.
  • Patients participating in another clinical study.
  • Patients who underwent PCI (percutaneous coronary intervention) or CABG (coronary artery bypass grafting) before the index CTA.

Treatment and study plan

Iopromide (Ultravist, BAY86-4877)

Drug

8 settings for CT Angiography as described in group description.

Primary outcomes

  1. Contrast opacification of the target vascular segments, measured in Hounsfield Units (HU)

    Time frame: Up to 1 week

    Defined as the CT value which can be measured on the CTA images.

Secondary outcomes

  1. Value of CNR (contrast-noise ratio) of the vascular segments

    Time frame: Up to 1 week

    Calculated by the formula: CNR = [Averaged vascular segmental CT value - brain parenchyma (for carniocervical CTA) / perivascular tissues (for Coronary CTA (CCTA)) CT value] / image noise

  2. Value of SNR (signal-noise ratio) of the vascular segments

    Time frame: Up to 1 week

    Calculated by the formula: SNR = Averaged vascular segmental CT value / image noise

  3. Score of visual assessment of the CTA image quality

    Time frame: Up to 1 week

    Subjective visual assessment using a 4-point scale:

    • Non-diagnostic
    • Adequate
    • Good
    • Excellent

  4. Score of diagnostic confidence of the CTA images

    Time frame: Up to 1 week

    Subjective assessment of diagnostic confidence in the delineation of pathologic findings using a 4-point scale:

    • Insufficient
    • Adequate
    • Good
    • Excellent

  5. Injected dosage (ml) of the contrast media (CM)

    Time frame: Up to 24 hours

    Can be read from the screen of the CT injector.

  6. Injection rate (ml/s) of the contrast media

    Time frame: Up to 24 hours

    Can be read from the screen of the CT injector.

  7. Value of the Idoine delivery rate (IDR) (unit: mg I/s)

    Time frame: Up to 1 week

    Calculated by the formula:

    IDR (mg I/s) = CM concentration (mg I/ml) * CM injection rate (ml/s)

  8. Value of the volume CT dose index (CTDIvol) (unit: mGy)

    Time frame: Up to 1 week

    A parameter of the radiation dose which can be automatically generated and recorded by the CT machine.

  9. Value of the dose length product (DLP) (unit: mGy*cm)

    Time frame: Up to 1 week

    A parameter of the radiation dose which can be automatically generated and recorded by the CT machine.

  10. Value of the effective dose (organ dose) (unit: mSv)

    Time frame: Up to 1 week

    The effective radiation dose which can be estimated by DLP multiplied by a specific conversion coefficient.

  11. Heart rate of the patients who underwent CCTA before and after the CM injection

    Time frame: Up to 24 hours

    It can be read from the screen of the ECG monitor of the CT machine

  12. Presence of injection pain or discomfort of the patients (Yes/No)

    Time frame: Up to 24 hours

    Assessed by investigators by asking patients if they have injection pain or discomfort.

  13. Number of patients with adverse events / adverse drug reactions

    Time frame: Up to 1 hour

  14. Severity of injection pain or discomfort of the patients

    Time frame: Up to 24 hours

    Assessed by investigators by asking the patients of the severity (mild, moderate, severe) if present.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Study of the Image Quality in Coronary or Craniocervical CT Angiography With Different Iodine Delivery Rates Using Low Tube Voltage (80 or 100 kV) Imaging in MDCT

Acronym: RIGHT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 21, 2016
Registry last updated
Oct 2, 2018

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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