Cardiac Remodelling Following Endovascular Repair of the Aorta
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- To estimate cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular mass with those obtained after a 12-month period.
研究概览
简要总结
To assess the effects of endovascular aortic repair on cardiac morphology and function
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will undergo a pre-surgery evaluation: clinical evaluation, blood sampling, CT-scan, echocardiography and cardiac magnetic resonance.
The same evaluation will be performed at 6- and 12-months post-surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •- Patients over 18-year-old, with degenerative arch, descending thoracic or abdominal aortic aneurysms, penetrating aortic ulcers or intramural hematomas managed with total EVAR in elective setting.
排除标准
- •Heart failure with an ejection fraction <35 vs 50% or New York Heart Association (NYHA) class III and IV.
- •LV wall motion abnormality.
- •Moderate to severe valve disease.
- •History of (or expected within the study period) cardiac/aortic surgery.
- •Coronary artery disease.
- •Atrial fibrillation.
- •Congenital heart disease.
- •Connective tissue disorders.
- •Chronic kidney disease (eGFR <30 mL/min/173 m2).
- •Moderate to severe pulmonary disease as indicate either by post bronchodilator FEV1 (%predicted) <50% or Modified Medical Research Council Dyspnoea Scale (mMRC) 3-
- •CMR contraindications (non-compatible pacemakers and metal implants, and claustrophobia).
研究组 & 干预措施
Participants submitted to aortic repair
Participants submitted endovascular repair of the aorta
干预措施: cardiac magnetic ressonance (Diagnostic Test)
结局指标
主要结局
To estimate cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular mass with those obtained after a 12-month period.
时间窗: 12-month period
The cardiac remodelling will be estimated through the variables of left ventricular mass at baseline and 12 months, measured in grams through CMR.
次要结局
- To estimate the cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular mass/volume/strain measurements with those obtained after a 6-month period.(6-month period)
- To estimate cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular volume and strain measurements with those obtained after a 12-month period.(12-months period)
- To estimate the cardiac remodelling in patients who have undergone EVAR by comparing baseline ECHO and CMR cardiac measurements with those obtained after 6- and 12-months periods.(6- and 12-months periods)
- To correlate heart proximity and endograft extension with cardiac remodelling variables.(12-month period)
- To create a composite variable using cardiac biomarkers that correlate with cardiac remodelling variables at 6-months and 12-months(6-month and 12-month periods)
- To compare the agreement between measurements ECHO and CMR measurements.(12-month period)
- To evaluate trends in the patient's blood pressure profile as a possible first sign of the hemodynamic changes induced by EVAR.(1-month, 6-months and 12-month period.)
研究者
Augusto Ministro
Principal Investigator, Academic and Clinical Professor
Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa