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

NCT04958083 | Unknown

• 1 other identifier: 4D Motion-2 IRAS284431
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

aortic disease; finite element analysis; virtual stenting; focal wall stress

Outcome Measures

Primary Outcomes (2)

• motion differential

  Quantitative assessment of differential of aortic motion before and after surgery/intervention

  6 months after the last participant has post-procedure dynamic CT scan

• motion predicting aortic events

  Motion differences before-after procedure with regards to later aortic events.

  6 months after the last participant finished 1 year clinical follow up

Secondary Outcomes (1)

• wall stress distribution

  6 months after the last participant has post-procedure dynamic CT scan

Study Arms (1)

aortopathy patient

EXPERIMENTAL

Patients who have proximal aortic conditions and are referred to the aortic team in Royal Brompton and Harefield Hospitals will be screened for eligibility. For this pilot study and in view of the volume of aortic surgery in the Trust (approx. 100 cases per year), 30 patients will be recruited in the first year of this project to be followed for at least one year for clinical outcomes.

Diagnostic Test: multiphase ECG-gated contrast-enhanced CT

Interventions

multiphase ECG-gated contrast-enhanced CT DIAGNOSTIC_TEST

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.

aortopathy patient

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients above 18 years with proximal aortic dissection/aneurysm.
• Patients subjected to aortic surgery or intervention at Royal Brompton and Harefield Hospital.
• Patients agreeing to participate in this study and willing to give written consent.

You may not qualify if:

• Patients not suitable for surgery or intervention.
• Patients with pre-existing cancer condition or cancer predisposition.
• Patients who are pregnant.
• Patient with critical renal function who cannot tolerate to standard amount contrast agent.
• Patients who cannot give written informed consent.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton Hospital

London, United Kingdom

Location

Related Publications (14)

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MeSH Terms

Conditions

Aortic Dissection; Aortic Diseases

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome

Study Officials

• Christoph Nienaber, MD, PhD

  Royal Brompton and Harefield Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Nienaber, MD, PhD

CONTACT

+4402073528121; c.nienaber@rbht.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 12, 2021
• Study Start: August 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: July 12, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)