Impact of Endovascular Abdominal Aortic Aneurysm Repair on Aortic Stiffness and Left Ventricular Remodeling
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in arterial stiffness after endovascular aneurysm repair (EVAR)
研究概览
简要总结
Abdominal aortic aneurysm (AAA) is associated with a high burden of cardiovascular morbidity and mortality. Although endovascular aneurysm repair (EVAR) has become the preferred treatment for many patients with infrarenal AAA because of its lower perioperative risk, its impact on arterial stiffness and cardiac function remains insufficiently understood. Experimental and clinical evidence suggests that endograft implantation may increase aortic stiffness by reducing aortic compliance, potentially altering ventricular-arterial coupling and contributing to left ventricular remodeling and dysfunction.
This prospective observational study aims to evaluate the effects of elective EVAR on aortic stiffness, left ventricular structure and function, and circulating biomarkers of myocardial stress and extracellular matrix remodeling. Patients with infrarenal AAA scheduled for elective EVAR will be assessed before the procedure and at 48 hours, 6 months, and 12 months after intervention. Aortic stiffness will be assessed using estimated carotid-femoral pulse wave velocity (cfPWV), while left ventricular function and remodeling will be evaluated by transthoracic echocardiography, including global longitudinal strain (GLS). Circulating NT-proBNP and MMP-3 concentrations will also be measured.
The study will provide insight into the cardiovascular effects of EVAR and may improve understanding of procedure-related changes in arterial stiffness and cardiac remodeling, thereby supporting better long-term cardiovascular risk assessment and postoperative management in patients undergoing EVAR.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years of age) with diagnosed abdominal aortic aneurysm (AAA) who are scheduled for elective endovascular aneurysm repair (EVAR)
- •Patients eligible for EVAR according to current clinical guidelines and anatomical criteria
- •Signed informed consent for participation in the study
- •Ability to undergo scheduled follow-up examinations (baseline, early post-procedural assessment, and follow-up visits)
排除标准
- •Emergency EVAR for ruptured or symptomatic abdominal aortic aneurysm
- •Previous aortic repair or previous endovascular intervention involving the abdominal aorta
- •Concomitant major cardiovascular surgery or intervention during the study period
- •Severe hemodynamic instability or critical illness at the time of inclusion
- •Active infection or acute inflammatory disease that may influence vascular or inflammatory biomarkers
- •Malignancy with active treatment or life expectancy limiting follow-up
- •Inability to provide informed consent
- •Inability to complete planned follow-up assessments
- •Known severe valvular heart disease or advanced heart failure
- •Conditions affecting arterial stiffness measurements (e.g. atrial fibrillation, severe arrhythmias, inability to obtain reliable PWV measurements)
研究组 & 干预措施
EVAR patients
Patients undergoing endovascular aneurysm repair (EVAR) with assessment of arterial stiffness and cardiac function before the procedure and during follow-up (2 days, 6 months, and 12 months after EVAR).
结局指标
主要结局
Change in arterial stiffness after endovascular aneurysm repair (EVAR)
时间窗: Baseline (pre-EVAR) to 12 months after EVAR (2 days, 6 months, 12 months)
Change in arterial stiffness after endovascular aneurysm repair (EVAR)
次要结局
- Early and long-term changes in arterial stiffness after EVAR(Baseline, 2 days, 6 months, 12 months)
- Changes in cardiac function after EVAR(Baseline, 2 days, 6 months, 12 months)
- Changes in circulating biomarkers after EVAR(Baseline, 2 days, 6 months, 12 months)
- Change in left ventricular ejection fraction (LVEF)(Baseline, 2 days, 6 months, 12 months)
- Change in left ventricular filling pressure (E/e')(Baseline, 2 days, 6 months, 12 months)
- Change in left atrial volume index (LAVI)(Baseline, 2 days, 6 months, 12 months)
- Change in left ventricular end-diastolic volume (LVEDV)(Baseline, 2 days, 6 months, 12 months)
- Change in left ventricular global longitudinal strain (LV GLS)(Baseline, 2 days, 6 months, 12 months)
- Change in left atrial reservoir strain (LA reservoir strain)(Baseline, 2 days, 6 months, 12 months)
研究者
Ines Drenjancevic
Ana Stupin, Vice-Dean for Science Faculty of Medicine Osijek
Josip Juraj Strossmayer University of Osijek