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4D Motion of the Aorta in the Chest and Simulated Wall Stress Distribution in Relation to Aortic Events

NCT04958083 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-07-12

No results posted yet for this study

Summary

Aortic disease is a life-threatening condition requires swift surgery or intervention. With modern techniques and vascular prostheses, still quite a few patients suffer surgery/intervention related complications such as suture line pseudoaneurysm, stent- induced re-entry tear, and aneurysmal expansion. Previous studies suggest that these complications may be related to the abnormal aortic motion pattern and biomechanical stress induced by vascular prostheses. The relationship between aortic motion changes and aortic adverse events after treatment still remains unclear.

A dynamic protocol (multiphase contrast-enhanced ECG-gated) CT scan is able to measure the spatial motion of the ascending aorta, and finite element modelling is able to simulate both surgery or endovascular intervention and analyse the biomechanical interaction between vascular prostheses and tissue based on the patient-specific images. This project is aiming to explore and identify the interaction of 4D aortic motion and the biomechanical changes after surgery or endovascular treatment.

Conditions

  • Aortic Dissection

Interventions

DIAGNOSTIC_TEST

multiphase ECG-gated contrast-enhanced CT

Compared with current standard CT imaging, the dynamic CT protocol provides incremental functional information, which is potentially helpful to the individuals under study (such as early awareness for future complications and potential prediction of outcomes). Due to the nature of the acquisition, a wider R-R acquisition window will result in a higher radiation burden than a standard protocol. However, the study protocol will replace the standard routine CT image protocol as it contains both the routine anatomic information and incremental functional information. The time required for the image acquisition and associated radiation will be slightly higher; the additional information from multiple reconstructed phases will justify a slightly higher radiation burden in a usually elderly population. The estimated radiation dose for the standard imaging protocol is approximately 8 mSv. The estimated radiation dose for the modified dynamic CT image acquisition is approximately 18 mSv.

Sponsors & Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Christoph Nienaber, MD, PhD · Royal Brompton and Harefield Hospitals

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-31
Primary Completion
2022-12-31
Completion
2023-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04958083 on ClinicalTrials.gov