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

NCT ID: NCT02840903

Last Updated: 2018-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1214 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-26

Study Completion Date

2017-10-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Angiography Multidetector Computed Tomography

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Iopromide (Ultravist, BAY86-4877)

Intervention Type DRUG

8 settings for CT Angiography as described in group description.

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

Iopromide (Ultravist, BAY86-4877)

Intervention Type DRUG

8 settings for CT Angiography as described in group description.

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

Iopromide (Ultravist, BAY86-4877)

Intervention Type DRUG

8 settings for CT Angiography as described in group description.

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

Iopromide (Ultravist, BAY86-4877)

Intervention Type DRUG

8 settings for CT Angiography as described in group description.

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

Iopromide (Ultravist, BAY86-4877)

Intervention Type DRUG

8 settings for CT Angiography as described in group description.

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

Iopromide (Ultravist, BAY86-4877)

Intervention Type DRUG

8 settings for CT Angiography as described in group description.

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

Iopromide (Ultravist, BAY86-4877)

Intervention Type DRUG

8 settings for CT Angiography as described in group description.

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

Iopromide (Ultravist, BAY86-4877)

Intervention Type DRUG

8 settings for CT Angiography as described in group description.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Iopromide (Ultravist, BAY86-4877)

8 settings for CT Angiography as described in group description.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Multiple Locations, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35103828 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://clinicaltrials.bayer.com/

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17811

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.