Trial Condition(s):
Angiography, Multidetector Computed Tomography
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)
Bayer Identifier:
17811
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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.
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.
Trial Summary
Enrollment Goal
1214
Trial Dates
Phase
4
Could I receive a placebo?
No
Products
Ultravist (Iopromide, BAY86-4877)
Accepts Healthy Volunteers
No
Where to Participate
Loading...
Locations
Status
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
8
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.Timeframe: Up to 1 week
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 noiseTimeframe: Up to 1 week
- Value of SNR (signal-noise ratio) of the vascular segmentsCalculated by the formula: SNR = Averaged vascular segmental CT value / image noiseTimeframe: Up to 1 week
- Score of visual assessment of the CTA image qualitySubjective visual assessment using a 4-point scale: 1: Non-diagnostic 2: Adequate 3: Good 4: ExcellentTimeframe: Up to 1 week
- 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: ExcellentTimeframe: Up to 1 week
- Injected dosage (ml) of the contrast media (CM)Can be read from the screen of the CT injector.Timeframe: Up to 24 hours
- Injection rate (ml/s) of the contrast mediaCan be read from the screen of the CT injector.Timeframe: Up to 24 hours
- 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)Timeframe: Up to 1 week
- 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.Timeframe: Up to 1 week
- 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.Timeframe: Up to 1 week
- 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.Timeframe: Up to 1 week
- 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 machineTimeframe: Up to 24 hours
- Presence of injection pain or discomfort of the patients (Yes/No)Assessed by investigators by asking patients if they have injection pain or discomfort.Timeframe: Up to 24 hours
- Number of patients with adverse events / adverse drug reactionsTimeframe: Up to 1 hour
- Severity of injection pain or discomfort of the patientsAssessed by investigators by asking the patients of the severity (mild, moderate, severe) if present.Timeframe: Up to 24 hours
Additional Information
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