check_circleStudy Completed
Angiography, Multidetector Computed Tomography
Bayer Identifier:
17811
ClinicalTrials.gov Identifier:
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
BothAge
18 - N/ATrial summary
Enrollment Goal
1214Trial Dates
July 2016 - October 2017Phase
Phase 4Could I Receive a placebo
NoProducts
Ultravist (Iopromide, BAY86-4877)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 weekenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Value of CNR (contrast-noise ratio) of the vascular segmentsCalculated by the formula: CNR = [Averaged vascular segmental CT value - brain parenchyma (for carniocervical CTA) / perivascular tissues (for Coronary CTA (CCTA)) CT value] / image noisedate_rangeTime Frame:Up to 1 weekenhanced_encryptionNoSafety Issue:
- Value of SNR (signal-noise ratio) of the vascular segmentsCalculated by the formula: SNR = Averaged vascular segmental CT value / image noisedate_rangeTime Frame:Up to 1 weekenhanced_encryptionNoSafety Issue:
- Score of visual assessment of the CTA image qualitySubjective visual assessment using a 4-point scale: 1: Non-diagnostic 2: Adequate 3: Good 4: Excellentdate_rangeTime Frame:Up to 1 weekenhanced_encryptionNoSafety Issue:
- Score of diagnostic confidence of the CTA imagesSubjective assessment of diagnostic confidence in the delineation of pathologic findings using a 4-point scale: 1: Insufficient 2: Adequate 3: Good 4: Excellentdate_rangeTime Frame:Up to 1 weekenhanced_encryptionNoSafety Issue:
- Injected dosage (ml) of the contrast media (CM)Can be read from the screen of the CT injector.date_rangeTime Frame:Up to 24 hoursenhanced_encryptionNoSafety Issue:
- Injection rate (ml/s) of the contrast mediaCan be read from the screen of the CT injector.date_rangeTime Frame:Up to 24 hoursenhanced_encryptionNoSafety Issue:
- 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 weekenhanced_encryptionNoSafety Issue:
- 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 weekenhanced_encryptionNoSafety Issue:
- 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 weekenhanced_encryptionNoSafety Issue:
- 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 weekenhanced_encryptionNoSafety Issue:
- Heart rate of the patients who underwent CCTA before and after the CM injectionIt can be read from the screen of the ECG monitor of the CT machinedate_rangeTime Frame:Up to 24 hoursenhanced_encryptionNoSafety Issue:
- 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 hoursenhanced_encryptionYesSafety Issue:
- Number of patients with adverse events / adverse drug reactionsdate_rangeTime Frame:Up to 1 hourenhanced_encryptionYesSafety Issue:
- Severity of injection pain or discomfort of the patientsAssessed by investigators by asking the patients of the severity (mild, moderate, severe) if present.date_rangeTime Frame:Up to 24 hoursenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A