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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 (RIGHT)

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ClinicalTrials.gov Identifier: NCT02840903
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment
Angiography Multidetector Computed Tomography Drug: Iopromide (Ultravist, BAY86-4877)

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 1214 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : July 26, 2016
Actual Primary Completion Date : July 28, 2017
Actual Study Completion Date : October 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans
Drug Information available for: Iopromide

Group/Cohort Intervention/treatment
Setting 1 of Iopromide
Craniocervical CTA under below setting: injection rate of iopromide: 4 ml/s, concentration of iopromide = 300 mgI/ml, injection dose of iopromide: 0.8 ml/kg BW, tube voltage = 80 kvp
Drug: Iopromide (Ultravist, BAY86-4877)
8 settings for CT Angiography as described in group description.

Setting 2 of Iopromide
Craniocervical CTA under below setting: injection rate of iopromide: 3.2 ml/s, concentration of iopromide = 370 mgI/ml, injection dose of iopromide: 0.65 ml/kg BW, tube voltage = 80 kvp
Drug: Iopromide (Ultravist, BAY86-4877)
8 settings for CT Angiography as described in group description.

Setting 3 of Iopromide
Craniocervical CTA under below setting: injection rate of iopromide: 3.2 ml/s, concentration of iopromide = 300 mgI/ml, injection dose of iopromide: 0.8 ml/kg BW, tube voltage = 80 kvp
Drug: Iopromide (Ultravist, BAY86-4877)
8 settings for CT Angiography as described in group description.

Setting 4 of Iopromide
Craniocervical CTA under below setting: injection rate of iopromide: 4 ml/s, concentration of iopromide = 370 mgI/ml, injection dose of iopromide: 0.8 ml/kg BW, tube voltage = 100 kvp
Drug: Iopromide (Ultravist, BAY86-4877)
8 settings for CT Angiography as described in group description.

Setting 5 of Iopromide
Coronary CTA under below setting: injection rate of iopromide: 4 ml/s, concentration of iopromide = 300 mgI/ml, injection dose of iopromide: 0.8 ml/kg BW, tube voltage = 80 kvp
Drug: Iopromide (Ultravist, BAY86-4877)
8 settings for CT Angiography as described in group description.

Setting 6 of Iopromide
Coronary CTA under below setting: injection rate of iopromide: 3.2 ml/s, concentration of iopromide = 370 mgI/ml, injection dose of iopromide: 0.65 ml/kg BW, tube voltage = 80 kvp
Drug: Iopromide (Ultravist, BAY86-4877)
8 settings for CT Angiography as described in group description.

Setting 7 of Iopromide
Coronary CTA under below setting: injection rate of iopromide: 3.2 ml/s, concentration of iopromide = 300 mgI/ml, injection dose of iopromide: 0.8 ml/kg BW, tube voltage = 80 kvp
Drug: Iopromide (Ultravist, BAY86-4877)
8 settings for CT Angiography as described in group description.

Setting 8 of Iopromide
Coronary CTA under below setting: injection rate of iopromide: 4 ml/s, concentration of iopromide = 370 mgI/ml, injection dose of iopromide: 0.8 ml/kg BW, tube voltage = 100 kvp
Drug: Iopromide (Ultravist, BAY86-4877)
8 settings for CT Angiography as described in group description.




Primary Outcome Measures :
  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 Outcome Measures :
  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:

    1. Non-diagnostic
    2. Adequate
    3. Good
    4. 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:

    1. Insufficient
    2. Adequate
    3. Good
    4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients referred for CT Angiography for examination of the cerebral arteries (suspicion of cerebral artery stenosis or embolism, or suspected carotid pathology) or for examination of the coronary arteries receiving Ultravist at 80 or 100 kV can be enrolled in this study.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840903


Locations
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China
Multiple Locations, China
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02840903    
Other Study ID Numbers: 17811
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Keywords provided by Bayer:
CTA
Computed Tomographic Angiography