Comparación De La Eficacia Entre Biomarcadores Y Ecografía Con Contraste Frente a Angio-TC En El Seguimiento De Aneurismas De Aorta Abdominal (AAA) Tras Reparación Endovascular (EVAR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Biomarkers Levels for Endoleak Detection Post-EVAR Treatment
研究概览
简要总结
This prospective observational study evaluates the efficacy of contrast-enhanced ultrasound and biomarker determination in the follow-up of patients with abdominal aortic aneurysm (AAA) treated with Endovascular Aneurysm Repair (EVAR). Currently, computed tomography angiography (CTA) is the standard for follow-up, although it has disadvantages such as radiation exposure and the use of iodinated contrasts. Contrast-enhanced ultrasound (CEUS), free of radiation and nephrotoxicity, and biomarkers could reduce the need for CTA minimizing the associated risks. Biomarkers will be measured before and after EVAR and CEUS will be performed at various time points and compared with CTA results to validate concordance and effectiveness in detecting endoleaks and aneurysm remodeling. The objectives include determining the efficacy of these combined methods and establishing a follow-up protocol that reduces exposure to radiation and iodinated contrast agents.
详细描述
Background/Rationale:
Patients with AAA who have undergone EVAR of the abdominal aortic aneurysm require indefinite follow-up since a 4-year complication rate after EVAR of up to 40% has been described in some series.
In some patients a decrease in the diameters of the residual aneurysm sac after EVAR has been described, which is known as remodeling.
CTA is the gold standard imaging technique for the follow-up of these patients, although it has the disadvantage of using ionizing radiation and iodinated contrasts that are nephrotoxic and can produce hypersensitivity reactions. Furthermore, there is no consensus on which protocol is the most suitable (one phase, two phases or three phases). Currently, in our hospital, three-phase CTA is being performed, as well as CTA with the Split Bolus technique, which allows the acquisition of images in arterial and venous phases in a single acquisition, thus reducing radiation doses; a correlation between both techniques of 85.7-100% and a decrease in radiation doses of between 30-78% has been described.
An alternative to CTA is CEUS that presents a sensitivity of 90.5% (22-100%) and a specificity of 90.65% (71-100%) for the detection of endoleaks. It is a technique that does not use ionizing radiation; furthermore, ultrasound contrasts are not nephrotoxic and hypersensitivity reactions to them are exceptional. In addition, there are publications concerning the determination of biomarkers in the follow-up of patients with AAA both before and after treatment with 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
- •patients with AAA under follow-up who are going to be treated with EVAR.
- •signed informed consent to perform CTA, CEUS and for the determination of biomarkers.
排除标准
- •patients with inflammatory abdominal aortic aneurysms or ruptured aneurysm.
结局指标
主要结局
Biomarkers Levels for Endoleak Detection Post-EVAR Treatment
时间窗: Biomarkers will be evaluated before (within 30 days prior to the procedure) and after implantation of the endoprosthesis (24-48 hours, 1 month, 3 months, 6 months, and 1 year).
To determine if biomarker levels can detect endoleaks as a complication in patients treated for AAA, changes in biomarker levels will be compared to baseline values and subsequent assessments. Outcome Measure: Change in Endoleak Biomarkers from baseline to 1 year. Biomarkers and Units of Measure: * Extracellular Matrix Remodeling Markers: Matrix Metalloproteinase-9 (MMP-9) (ng/mL) * Renal Function Markers: Cystatin C (mg/L) * Coagulation Markers: von Willebrand Factor (%), Factor VIII (IU/dL) Analysis: Each biomarker will be grouped into clinically relevant categories and analyzed as an independent measure within its respective category to assess its correlation with endoleak occurrence.
Biomarkers Levels for Thrombosis Detection Post-EVAR Treatment
时间窗: Biomarkers will be evaluated before (within 30 days prior to the procedure) and after implantation of the endoprosthesis (24-48 hours, 1 month, 3 months, 6 months, and 1 year).
To determine if biomarker levels detect thrombosis in AAA patients, changes will be compared to baseline values and subsequent assessments. Outcome Measure: Change in Thrombosis Biomarkers from baseline to 1 year. Biomarkers and Units of Measure: * Coagulation Markers: Prothrombin Time (PT) (seconds), Activated Partial Thromboplastin Time (aPTT) (seconds), Derived Fibrinogen (mg/dL), Factor XIII (%) * Platelet Function Markers: PFA-100 COL/ADP (seconds), PFA-100 COL/EPI (seconds) * Anticoagulation Markers: Protein C (%), Protein S (%), Antithrombin (%) * Thrombophilia Markers: Lupus Anticoagulant (Presence/Absence), Activated Protein C Resistance ((+/-)), Prothrombin G20210A Mutation ((+/-)), Factor V Leiden Mutation (G1691A) ((+/-)) Analysis: Each biomarker will be grouped into clinically relevant categories and analyzed as an independent measure within its respective category to track changes and assess their correlation with thrombosis.
Biomarkers Levels for Infection Detection Post-EVAR Treatment
时间窗: Biomarkers will be evaluated before (within 30 days prior to the procedure) and after implantation of the endoprosthesis (24-48 hours, 1 month, 3 months, 6 months, and 1 year).
To determine if biomarker levels can detect infection as a complication in patients treated for AAA, changes in biomarker levels will be compared to baseline values and subsequent assessments. Outcome Measure: Change in Infection Biomarkers from baseline to 1 year. Biomarkers and Units of Measure: - Inflammatory Markers: C-Reactive Protein (CRP) (mg/L); Procalcitonin (ng/mL); IL-6 (pg/mL); IL-8 (pg/mL); TNF-α (pg/mL); Serum Calprotectin (µg/mL) Analysis: Each biomarker will be grouped as an inflammatory marker and analyzed as an independent measure to track changes and assess its correlation with infection.
Biomarker Levels for Prosthesis-Related Complication Detection Post-EVAR Treatment
时间窗: Biomarkers will be evaluated before (within 30 days prior to the procedure) and after implantation of the endoprosthesis (24-48 hours, 1 month, 3 months, 6 months, and 1 year).
To determine whether biomarker levels can detect complications such as displacement, dislocation, and plication of the prosthesis in patients treated for AAA, changes in biomarker levels will be compared to baseline values and subsequent assessments. Outcome Measure: Change in Biomarkers Related to Prosthesis Issues from baseline to 1 year. Biomarkers and Units of Measure: * Lipid Metabolism Markers: Apolipoprotein A1 (ApoA1) (mg/dL), Apolipoprotein B (ApoB) (mg/dL) * Hematological Markers: Reticulocytes (10³/mL) * Coagulation Markers: Quick Index (%) * Autoimmune Markers: Anticardiolipin Antibodies (IgG/IgM) (GPL/MPL units) Analysis: Each biomarker will be grouped into clinically relevant categories and treated as an independent measure within its respective category.
CEUS (Contrast-Enhanced Ultrasound) for Endoleak Detection Post-EVAR treatment
时间窗: CEUS will be performed at baseline (within 30 days before the procedure) and after implantation of the endoprosthesis: 24-48 hours, 1 month, 3 months, 6 months, and 1 year.
Objective: To determine if CEUS can detect endoleaks, thrombosis, infection, and complications related to protesis placement (displacement/dislocation of the prosthesis, plication of the prosthesis) in patients treated for AAA. • Units of Measure: Presence/absence of endoleaks, thrombosis, infection, displacement/dislocation of the prosthesis, plication of the prosthesis Comments: The presence or absence of endoleaks and other complications will be assessed, along with severity when applicable
Validation of Biomarkers for Endoleaks Detection Post EVAR
时间窗: Biomarkers will be assessed at baseline (within 30 days prior to the procedure) and after implantation of the endoprosthesis: 24-48 hours, 1 month, 3 months, 6 months, and 1 year.
To validate biomarkers for detecting endoleaks as a post-EVAR complication, changes in biomarker levels will be compared to baseline values and subsequent assessments. Outcome Measure: Change in Endoleak Biomarkers from baseline to 1 year. Biomarkers and Units of Measure: * Extracellular Matrix Remodeling Markers: Matrix Metalloproteinase-9 (MMP-9) (ng/mL) * Renal Function Markers: Cystatin C (mg/L) * Coagulation Markers: von Willebrand Factor (%), Factor VIII (IU/dL) Analysis: Each biomarker will be grouped into clinically relevant categories and analyzed as an independent measure within its respective category to assess its correlation with endoleak occurrence
Validation of CEUS for Endoleak and Complication Detection Post-EVAR treatment
时间窗: CEUS will be performed at baseline (within 30 days before the procedure) and after implantation of the endoprosthesis: 24-48 hours, 1 month, 3 months, 6 months, and 1 year.
Objective: To validate the use of Contrast-Enhanced Ultrasound (CEUS) for detecting endoleaks, thrombosis, infection, and complications related to protesis placement (displacement/dislocation of the prosthesis, plication of the prosthesis) in patients treated for AAA, compared to angio-CT (gold standard). * Units of Measure: Presence/absence of endoleaks, thrombosis, infection, displacement/dislocation of the prosthesis, plication of the prosthesis * Comparison Standard: Angio-CT (gold standard) Comments: The presence or absence of endoleaks and other complications will be assessed, along with severity when applicable. CEUS results will be compared to the angio-CT results for validation.
Validation of Biomarkers for Thrombosis Detection Post-EVAR treatment
时间窗: Biomarkers will be assessed at baseline (within 30 days prior to the procedure) and after implantation of the endoprosthesis: 24-48 hours, 1 month, 3 months, 6 months, and 1 year.
To validate biomarkers for detecting thrombosis as a post-EVAR complication, changes in biomarker levels will be compared to baseline values and subsequent assessments. Outcome Measure: Change in Thrombosis Biomarkers from baseline to 1 year. Biomarkers and Units of Measure: * Coagulation Markers: Prothrombin Time (PT) (seconds), Activated Partial Thromboplastin Time (aPTT) (seconds), Derived Fibrinogen (mg/dL), Factor XIII (%) * Platelet Function Markers: PFA-100 COL/ADP (seconds), PFA-100 COL/EPI (seconds) * Anticoagulation Markers: Protein C (%), Protein S (%), Antithrombin (%) * Thrombophilia Markers: Lupus Anticoagulant (Presence/Absence), Activated Protein C Resistance ((+/-)), Prothrombin G20210A Mutation ((+/-)), Factor V Leiden Mutation (G1691A) ((+/-)) Analysis: Each biomarker will be grouped into clinically relevant categories and analyzed as an independent measure within its respective category to track changes and assess their correlation with thrombosis.
Validation of Biomarkers for Infection Detection Post-EVAR treatment
时间窗: Biomarkers will be assessed at baseline (within 30 days prior to the procedure) and after implantation of the endoprosthesis: 24-48 hours, 1 month, 3 months, 6 months, and 1 year.
To validate biomarkers for detecting infection as a post-EVAR complication, changes in biomarker levels will be compared to baseline values and subsequent assessments. Outcome Measure: Change in Infection Biomarkers from baseline to 1 year. Biomarkers and Units of Measure: - Inflammatory Markers: C-Reactive Protein (CRP) (mg/L); Procalcitonin (ng/mL); IL-6 (pg/mL); IL-8 (pg/mL); TNF-α (pg/mL); Serum Calprotectin (µg/mL) Analysis: Each biomarker will be grouped as an inflammatory marker and analyzed as an independent measure to track changes and assess its correlation with infection.
Validation of Biomarkers for Prosthesis-Related Complication Detection Post-EVAR Treatment
时间窗: Biomarkers will be assessed at baseline (within 30 days prior to the procedure) and after implantation of the endoprosthesis: 24-48 hours, 1 month, 3 months, 6 months, and 1 year.
To validate biomarkers for detecting complications such as displacement, dislocation, and plication of the prosthesis, changes in biomarker levels will be compared to baseline values and subsequent assessments. Outcome Measure: Change in Biomarkers Related to Prosthesis Issues from baseline to 1 year. Biomarkers and Units of Measure: * Lipid Metabolism Markers: Apolipoprotein A1 (ApoA1) (mg/dL), Apolipoprotein B (ApoB) (mg/dL) * Hematological Markers: Reticulocytes (10³/mL) * Coagulation Markers: Quick Index (%) * Autoimmune Markers: Anticardiolipin Antibodies (IgG/IgM) (GPL/MPL units) Analysis: Each biomarker will be grouped into clinically relevant categories and analyzed as an independent measure within its respective category.
次要结局
- Cost-Effectiveness of Biomarker Measurements in AAA Follow-Up Post-EVAR treatment(Biomarkers will be evaluated before (within 30 days prior to the procedure) and after implantation of the endoprosthesis (24-48 hours, 1 month, 3 months, 6 months, and 1 year).)
- Cost-Effectiveness of Imaging (CEUS and CTA) in AAA Follow-Up Post-EVAR treatment(Imaging techniques (CEUS and CTA) will be performed at the same time points as biomarker assessments (within 30 days before the procedure, and after implantation: 24-48 hours, 1 month, 3 months, 6 months, and 1 year))