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The CardiOvascular Remodeling Following Endovascular Aortic Repair (CORE) Study

NCT02735720 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 19

Last updated 2022-06-06

No results posted yet for this study

Summary

The use of TEVAR is increasing rapidly and patients even in younger patients. However, current endografts are several orders of magnitude stiffer than the native aorta. Pre-clinical and clinical studies have reported acute aortic stiffening after TEVAR resulting in hypertension, elevated pulse pressure, cardiac remodeling, reduced coronary perfusion, and finally, heart failure. These effects are markedly profound in young patients, as their hearts and aortas are more compliant. Previous studies on adverse cardiovascular remodeling have important limitations, such as retrospective design, use of echocardiography (with low reproducibility and high operator-dependency), and mixed populations. A systematic assessment of the deleterious effects of TEVAR is still missing.

The objective of this study is to perform a prospective, non-randomized controlled, study in which blood pressure, heart rate, ECG, echocardiography, CT, MRI, intra-luminal hemodynamic assessment, computational modeling and biomarkers are used to assess cardiovascular remodeling following TEVAR. This study targets patients with thoracic aortic aneurysms (TAA) or penetrating aortic ulcers (PAU) treated with TEVAR. A control group will consist of TAA and PAU subjects who do not require endovascular treatment.

The specific aims of the study include: 1) Quantification of cardiovascular remodeling following TEVAR in TAA or PAU patients. 2) Validation of computational modeling of thoracic aortic hemodynamics following TEVAR using the above clinical measurements. Once validated, computational analyses will be performed to virtually assess the impact of more compliant endografts on cardiac and aortic hemodynamics. 3) Investigation of diagnostic accuracy of ECG, BNP, NT-pro-BNP and Troponin T, for cardiac remodeling compared to MRI, the reference method.

This study will assess the impact of thoracic aortic stent grafts on the cardiovascular system through non-invasive measurements. Although there are no direct benefits for the enrolled subjects, future aortic patients might benefit from better patient management with improved aortic endograft designs and long-term outcomes.

Conditions

  • Thoracic Aortic Aneurysm

Interventions

OTHER

TEVAR

Thoracic endovascular aortic repair, which includes the implantation of stent-graft in the thoracic aorta to repair the lesion. This may be done with a variety of stent-graft brands and types. The type and brand of stent-graft is left to the discretion of the care taking physician.

OTHER

Non-TEVAR medical treatment

Any clinical management by physicians caring for these patients. This includes whatever blood pressure and heart rate medication is prescribed by the treating physician, without any surgery. The type and dosage of medication is left to the discretion of the care taking physician.

Sponsors & Collaborators

Principal Investigators

  • Alberto C Figueroa, PhD · Departments of Biomedical Engineering and Surgery, University of Michigan, USA

Eligibility

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

Timeline & Regulatory

Start
2017-03-14
Primary Completion
2020-02-21
Completion
2020-02-21

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02735720 on ClinicalTrials.gov