The CardiOvascular Remodeling Following Endovascular Aortic Repair (CORE) Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Changes in left ventricular mass (g), quantified with cardiac MRI
研究概览
简要总结
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.
详细描述
Patient Population and Clinical Measurements:
The Frankel Cardiovascular Center at the University of Michigan Health System (UMHS) is a regional center with expertise in managing a large variety of aortic diseases. Only adult patients (age between 18-99 years) will be included. Patients will be included regardless of race or ethnicity. The patient population consists of:
- Patients with a descending thoracic aortic aneurysm (TAA). TAA is defined by a balloon-like dilatation of the thoracic aorta. Such a dilatation may grow and eventually rupture, associated with high mortality. In the United States, more than 10,000 patients die every year due to a ruptured aneurysm. Current United States guidelines state that when the diameter of a TAA in patients with no connective tissue disorder is larger than 55-60 mm, aortic repair is recommended. To date, TEVAR is the first choice of therapy unless the anatomy is unsuitable or the patient has a connective tissue disorder.
- Patients with a penetrating aortic ulcer (PAU). PAU is a chronic aortic condition, defined by an ulcer-like disruption of the inner aortic wall. Up to 28% of patients with a PAU may have or may develop an aortic aneurysm. Treatment with TEVAR is recommended for these patients, especially when patients are complicated by aortic growth or rupture.
Study Design:
TEVAR Group. In this study, the investigators target both TAA and PAU treated with TEVAR. Patients are to be identified in the clinic setting. Patients who are planned for treatment TEVAR for TAA and PAU (based on their treating physician's decision) will be given information about this observational study. Results for the standard work-up examinations for TEVAR, which consist of computed tomography (CT), echocardiography, blood (BP) and heart (HR) measurements, and electrocardiogram (ECG) will be collected. Once patient consent is confirmed, and prior to the TEVAR procedure, this study will include a non-invasive MRI scan and a blood collection for the biomarker data, in addition to the standard of care. In this study, during the TEVAR procedure, intraluminal pressure measurements will be conducted using the catheters and guidewires that will be already in place for the deployment of the endograft. This study will neither delay or modify their endovascular procedure. One year (between a window of 275 - 455 days) following the TEVAR procedure, the subject will undergo and a second non-invasive MRI study in addition to the standard clinical imaging follow-up. During this follow-up imaging, the patients will also undergo BP and HR measurements, ECG and blood tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with descending thoracic aortic aneurysms or with penetrating aortic ulcers.
- •Subject willing to return for one year follow up and comply with protocol requirements.
排除标准
- •Ejection fraction < 35%; LV wall motion abnormality
- •Poor renal function (estimated glomerular filtration rate (eGFR) < 60 mL/min/173 m2)
- •Pregnancy
- •Connective tissue disorder
- •Significant valve, lung or congenital heart disease
- •History of cardiac or aortic surgery
- •Expected cardiac or aortic surgery within the study period
- •Standard MRI contraindications (pacemakers, non-compatible metal implants, and claustrophobia)
结局指标
主要结局
Changes in left ventricular mass (g), quantified with cardiac MRI
时间窗: 1 year
This will be quantified in grams.
次要结局
- Myocardial perfusion using MRI perfusion sequences.(1 year)
- Diagnostic accuracy of ECG for cardiac remodelling compared to MRI(1 year)
- Diagnostic accuracy of ECG alone, and in combination with BNP, NT-pro-BNP, and Troponin T for cardiac remodelling compared to MRI(1 year)
- Myocardial strain (%) using MRI sequences.(1 year)
- Central aortic pulse wave velocity using phase-contrast MRI.(1 year)
- Aortic strain (%) using MRI sequences.(1 year)
- Validation of computational modelling of thoracic aortic hemodynamics (i.e. velocity, flow, and pressure) following TEVAR against intra-luminal pressures and MRI.(1 year)
- Early-to-late atrial filling ratios measured through cardiac MRI(1 year)
- Aortic flow (ml/min) measured through cardiac MRI(1 year)
研究者
Alberto Figueroa
Principal Investigator
University of Michigan