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:

NCT02840903

EudraCT 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
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Ultravist (Iopromide, BAY86-4877)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, China

Status
Completed
 

Trial Design