Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02735720 · ClinicalTrials.gov registry record
The CardiOvascular Remodeling Following Endovascular Aortic Repair (CORE) Study
A clinical trial, sponsored by University of Michigan.
- Terminated
- Registry status
- 19
- Enrollment target
NCT02735720 is a clinical trial that was terminated before completion, run by University of Michigan. The registered enrollment target is 19 participants.
The verdict
NCT02735720 was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- 19 participants
- Enrollment target
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
Interventions
- OTHER TEVAR
- OTHER Non-TEVAR medical treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2017-03-14 |
| Est. Completion | 2020-02-21 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02735720
The ClinicalTrials.gov registry entry for NCT02735720 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TEVAR is the first listed.
NCT02735720 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02735720 about?
NCT02735720 is a clinical study titled "The CardiOvascular Remodeling Following Endovascular Aortic Repair (CORE) Study". 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 press...
What is the current status of trial NCT02735720?
This trial is currently terminated. The enrollment target is 19 participants. The study started on 2017-03-14. Estimated completion is 2020-02-21.
What interventions are being tested in trial NCT02735720?
The interventions under investigation include: TEVAR (OTHER), Non-TEVAR medical treatment (OTHER).
Who is sponsoring clinical trial NCT02735720?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.