Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angiography
Multidetector Computed Tomography
Keywords: CTA
Computed Tomographic Angiography
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-07-21
Enrollment: 1214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Contrast opacification of the target vascular segments, measured in Hounsfield Units (HU)
timeFrame: Up to 1 week
Secondary outcomes:
measure: Value of CNR (contrast-noise ratio) of the vascular segments
timeFrame: Up to 1 week
measure: Value of SNR (signal-noise ratio) of the vascular segments
timeFrame: Up to 1 week
measure: Score of visual assessment of the CTA image quality
timeFrame: Up to 1 week
measure: Score of diagnostic confidence of the CTA images
timeFrame: Up to 1 week
measure: Injected dosage (ml) of the contrast media (CM)
timeFrame: Up to 24 hours
measure: Injection rate (ml/s) of the contrast media
timeFrame: Up to 24 hours
measure: Value of the Idoine delivery rate (IDR) (unit: mg I/s)
timeFrame: Up to 1 week
measure: Value of the volume CT dose index (CTDIvol) (unit: mGy)
timeFrame: Up to 1 week
measure: Value of the dose length product (DLP) (unit: mGy*cm)
timeFrame: Up to 1 week
measure: Value of the effective dose (organ dose) (unit: mSv)
timeFrame: Up to 1 week
measure: Heart rate of the patients who underwent CCTA before and after the CM injection
timeFrame: Up to 24 hours
measure: Presence of injection pain or discomfort of the patients (Yes/No)
timeFrame: Up to 24 hours
measure: Number of patients with adverse events / adverse drug reactions
timeFrame: Up to 1 hour
measure: Severity of injection pain or discomfort of the patients
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Multiple Locations
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Wang Y, Chen Y, Liu P, Lv W, Wu J, Wei M, Shi D, Wu X, Liu W, Tao X, Hu H, Ma X, Yang X, Xue H, Jin Z. Clinical effectiveness of contrast medium injection protocols for 80-kV coronary and craniocervical CT angiography-a prospective multicenter observational study. Eur Radiol. 2022 Jun;32(6):3808-3818. doi: 10.1007/s00330-021-08505-5. Epub 2022 Feb 1.