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

NCT02840903 | Completed DMC

• 1 other identifier: 17811
• Study Type: observational
• Target: 1,214
• Locations: 1 country
• Sites: 1

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.

Conditions

Angiography; Multidetector Computed Tomography

Keywords

CTA; Computed Tomographic Angiography

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 week

Secondary Outcomes (14)

• Value of CNR (contrast-noise ratio) of the vascular segments

  Up to 1 week

• Value of SNR (signal-noise ratio) of the vascular segments

  Up to 1 week

• Score of visual assessment of the CTA image quality

  Up to 1 week

• Score of diagnostic confidence of the CTA images

  Up to 1 week

• Injected dosage (ml) of the contrast media (CM)

  Up to 24 hours

Study Arms (8)

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)

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)

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)

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)

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)

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)

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)

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)

Interventions

Iopromide (Ultravist, BAY86-4877) DRUG

8 settings for CT Angiography as described in group description.

Setting 1 of Iopromide; Setting 2 of Iopromide; Setting 3 of Iopromide; Setting 4 of Iopromide; Setting 5 of Iopromide; Setting 6 of Iopromide; Setting 7 of Iopromide; Setting 8 of Iopromide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Multiple Locations, China

Location

Related Publications (1)

• 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.

  PMID: 35103828 DERIVED

Related Links

• Click here to find results for studies related to Bayer products.

MeSH Terms

Interventions

iopromide

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 21, 2016
• Study Start: July 26, 2016
• Primary Completion: July 28, 2017
• Study Completion: October 11, 2017
• Last Updated: October 2, 2018

Record last verified: 2018-09

Locations

CN (1)