Personalization of contrast media Injection Protocols in Coronary Computed Tomographic Angiography [People CT trial]

Personalization of contrast media Injection Protocols in Coronary Computed Tomographic Angiography [People CT trial] - People CT trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45562

Enrollment

330

Registered

2016-12-28

Start date

2017-04-20

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary atherosclerosis

Interventions

NVT

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients referred for coronary CTA - Patient aged older than 18 and competent to give informed consent

Exclusion criteria

Exclusion criteria: - Inability to perform breath hold for at least the expected scan time - Hemodynamic instability - Pregnancy - Renal insufficiency (defined as GFR

Design outcomes

Primary

Measure	Time frame
To evaluate the performance of the individualised injection protocols in CCTA with regard to objective image quality (attenuation, image noise, CNR, and SNR), compared to the standard injection protocol. Additionally, to evaluate the performance of the individualised injection protocols in CCTA with regard to subjective image quality (4-point Likert scale), compared to the standard injection protocol.	—

Measure

Time frame

To evaluate the performance of the individualised injection protocols in CCTA with regard to objective image quality (attenuation, image noise, CNR, and SNR), compared to the standard injection protocol. Additionally, to evaluate the performance of the individualised injection protocols in CCTA with regard to subjective image quality (4-point Likert scale), compared to the standard injection protocol.

—

Secondary

Measure	Time frame
To detect and assess the presence and severity of CAD in patients undergoing CCTA with help of the CAD-RADS classification. The personalised injection protocols will make detection and assessment of coronary plaques possible, because the intravascular attenuation and image quality will be sufficient.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)