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

Status: Completed

Conditions: Angiography; Multidetector Computed Tomography

Treatments: Drug: Iopromide (Ultravist, BAY86-4877)

Study type: Observational

Funder types: Industry

Identifiers

NCT02840903

17811

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,214 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

1,214 participants in 8 patient groups

Setting 1 of Iopromide

Description:

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

Treatment:

Drug: Iopromide (Ultravist, BAY86-4877)

Setting 2 of Iopromide

Description:

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

Treatment:

Drug: Iopromide (Ultravist, BAY86-4877)

Setting 3 of Iopromide

Description:

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

Treatment:

Drug: Iopromide (Ultravist, BAY86-4877)

Setting 4 of Iopromide

Description:

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

Treatment:

Drug: Iopromide (Ultravist, BAY86-4877)

Setting 5 of Iopromide

Description:

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

Treatment:

Drug: Iopromide (Ultravist, BAY86-4877)

Setting 6 of Iopromide

Description:

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

Treatment:

Drug: Iopromide (Ultravist, BAY86-4877)

Setting 7 of Iopromide

Description:

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

Treatment:

Drug: Iopromide (Ultravist, BAY86-4877)

Setting 8 of Iopromide

Description:

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

Treatment:

Drug: Iopromide (Ultravist, BAY86-4877)