check_circleStudy Completed

Angiography, Multidetector Computed Tomography

Bayer Identifier:

17811

ClinicalTrials.gov Identifier:

NCT02840903

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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.
  • - 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.

Trial summary

Enrollment Goal
1214
Trial Dates
July 2016 - October 2017
Phase
Phase 4
Could I Receive a placebo
No
Products
Ultravist (Iopromide, BAY86-4877)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, China

Primary Outcome

  • Contrast opacification of the target vascular segments, measured in Hounsfield Units (HU)
    Defined as the CT value which can be measured on the CTA images.
    date_rangeTime Frame:
    Up to 1 week
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Value of CNR (contrast-noise ratio) of the vascular segments
    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
    date_rangeTime Frame:
    Up to 1 week
    enhanced_encryption
    Safety Issue:
    No
  • Value of SNR (signal-noise ratio) of the vascular segments
    Calculated by the formula: SNR = Averaged vascular segmental CT value / image noise
    date_rangeTime Frame:
    Up to 1 week
    enhanced_encryption
    Safety Issue:
    No
  • Score of visual assessment of the CTA image quality
    Subjective visual assessment using a 4-point scale: 1: Non-diagnostic 2: Adequate 3: Good 4: Excellent
    date_rangeTime Frame:
    Up to 1 week
    enhanced_encryption
    Safety Issue:
    No
  • Score of diagnostic confidence of the CTA images
    Subjective assessment of diagnostic confidence in the delineation of pathologic findings using a 4-point scale: 1: Insufficient 2: Adequate 3: Good 4: Excellent
    date_rangeTime Frame:
    Up to 1 week
    enhanced_encryption
    Safety Issue:
    No
  • Injected dosage (ml) of the contrast media (CM)
    Can be read from the screen of the CT injector.
    date_rangeTime Frame:
    Up to 24 hours
    enhanced_encryption
    Safety Issue:
    No
  • Injection rate (ml/s) of the contrast media
    Can be read from the screen of the CT injector.
    date_rangeTime Frame:
    Up to 24 hours
    enhanced_encryption
    Safety Issue:
    No
  • Value of the Idoine delivery rate (IDR) (unit: mg I/s)
    Calculated by the formula: IDR (mg I/s) = CM concentration (mg I/ml) * CM injection rate (ml/s)
    date_rangeTime Frame:
    Up to 1 week
    enhanced_encryption
    Safety Issue:
    No
  • Value of the volume CT dose index (CTDIvol) (unit: mGy)
    A parameter of the radiation dose which can be automatically generated and recorded by the CT machine.
    date_rangeTime Frame:
    Up to 1 week
    enhanced_encryption
    Safety Issue:
    No
  • Value of the dose length product (DLP) (unit: mGy*cm)
    A parameter of the radiation dose which can be automatically generated and recorded by the CT machine.
    date_rangeTime Frame:
    Up to 1 week
    enhanced_encryption
    Safety Issue:
    No
  • Value of the effective dose (organ dose) (unit: mSv)
    The effective radiation dose which can be estimated by DLP multiplied by a specific conversion coefficient.
    date_rangeTime Frame:
    Up to 1 week
    enhanced_encryption
    Safety Issue:
    No
  • Heart rate of the patients who underwent CCTA before and after the CM injection
    It can be read from the screen of the ECG monitor of the CT machine
    date_rangeTime Frame:
    Up to 24 hours
    enhanced_encryption
    Safety Issue:
    No
  • Presence of injection pain or discomfort of the patients (Yes/No)
    Assessed by investigators by asking patients if they have injection pain or discomfort.
    date_rangeTime Frame:
    Up to 24 hours
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of patients with adverse events / adverse drug reactions
    date_rangeTime Frame:
    Up to 1 hour
    enhanced_encryption
    Safety Issue:
    Yes
  • Severity of injection pain or discomfort of the patients
    Assessed by investigators by asking the patients of the severity (mild, moderate, severe) if present.
    date_rangeTime Frame:
    Up to 24 hours
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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