CT Angiography of the Aorta: Prospective Evaluation of an Individualized Low-Radiation Dose and Low-Volume Contrast Media Protocol with Dual-Energy CT for Detection of Endoleaks after Endovascular Aneurysm Repair

Not Applicable

• Conditions: CT angiography of the aorta; I71; Aortic aneurysm and dissection

• Registration Number: DRKS00013082
• Lead Sponsor: niversitätsklinikum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-03
• Study Completion: 2021-10-24
• Results First Posted: 2022-03-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 472

Inclusion Criteria

1) Clinically indicated CTA (CT Angiography) of the aorta without ECG-triggering, before or after aortic repair. 2) Informed written consent to participate in the study as well as consent to the scientific evaluation of the data.

Exclusion Criteria

1) Severe allergic reactions to iodine-based contrast agents if other imaging methods are possible. 2) Highly restricted renal function (eGFR < 20 mL/min) in patients who are currently not dependent upon dialysis if other imaging procedures are possible. 3) Planned radioiodine therapy or suspicion of thyroid tumors. 4) Pregnancy. 5) Emergency patients. 6) Patients with acute psychosis or other conditions that limit their understanding. 7) Patients who cannot lie still. 8) Patients with history of high grade cardiac insufficiency (NYHA Class III or IV).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Contrast (measured in Hounsfield units) of the CTA (computer tomographic angiography) using the individualized low-dose protocol.<br>

Secondary Outcome Measures

Name	Time	Method
Detection rate of endoleaks using a biphasic dual-energy CT protocol (arterial phase single-energy, delayed phase dual-energy) including the virtual native phase reconstructed from the delayed phase compared to the triphasic CT protocol (native, arterial and delayed phase).