Study of Biomarker Profiling to Unravel the Intertwined Pathophysiology of Coronary Artery Disease and Abdominal Aortic Aneurysm
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 440
- 试验地点
- 2
- 主要终点
- Volume of the aneurysm sac
研究概览
简要总结
The BIOMArCS-AAA study aims to investigate the associations of (temporal patterns of) blood biomarkers with aneurysm growth in patients with abdominal aortic aneurysm (AAA), with particular attention to biomarkers that have demonstrated prognostic value for adverse disease outcomes in coronary artery disease and biomarkers for the main genetic pathways associated with AAA.
详细描述
BIOMArCS-AAA is an observational, multicenter study. Patients with an abdominal aortic aneurysm (AAA) will be recruited through the vascular surgery outpatient clinic of Erasmus MC and Maasstad Ziekenhuis, the Netherlands. The prospective, longitudinal part of the study will include an arm with 120 AAA watchful waiting patients and an arm with 120 AAA patients undergoing endovascular aneurysm repair (EVAR), both with a 24-month follow-up period. Clinical data collection, and blood sampling will be conducted at baseline, at 1 month after EVAR and at 6, 12, 18 and 24 months for all patients. CT will be conducted at baseline and 12 and 24 months, plus at 1 month in the EVAR patients. Quality of life and depression questionnaires will be performed at baseline, at 12 and 24 months of follow-up in all patients, and at 1 month only in EVAR patients. Additionally, a cross-sectional study will be performed in 200 patients treated for AAA with EVAR in the past years. In these patients, clinical data collection, blood sampling, ultrasound and CT will be performed at their next regular outpatient clinic visit.
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
- •Age of 18 years or older
- •Capable of understanding and signing informed consent AND one of the following
- •Diagnosis of AAA, with a diameter ≥40mm, based on any imaging technique and treated by watchful waiting strategy (Prospective longitudinal study, Arm 1 watchful waiting group)
- •Planned to undergo EVAR for AAA (Prospective longitudinal study, Arm 2 EVAR group)
- •Underwent EVAR for AAA in past years (Cross-sectional study)
排除标准
- •Patients with isolated iliac artery aneurysm, traumatic aneurysm, anastomotic aneurysm and infectious aneurysm
- •Patients with a clinical diagnosed thoracic aneurysm (i.e. located in the chest, above the diaphragm)
- •Coexistent condition with life expectancy ≤ 1 year
- •Dialysis dependent, (end stage) renal disease patients
- •Women of childbearing age
- •Linguistic barrier
- •Unlikely to appear at all scheduled follow-up visits
结局指标
主要结局
Volume of the aneurysm sac
时间窗: Measured cross-sectionally, as well as repeatedly in the longitudinal part of the study by CT scan imaging during 24 months of follow-up.
The primary study endpoint is volume of the aneurysm sac. This will be measured cross-sectionally, as well as repeatedly in the longitudinal part of the study by CT scan imaging during 24 months of follow-up.
次要结局
- Maximal diameter of the aneurysm(Measured cross-sectionally, as well as repeatedly in the longitudinal part of the study during 24 months of follow-up.)
- Number of AAA-related adverse events in watchful waiting group(During 24 months of follow-up in the watchful-waiting patients of the longitudinal part of the study.)
- Quality of life measured according to the EuroQol questionnaire(Measured repeatedly during 24 months of follow-up in the longitudinal part of the study.)
- Depression measured according to the Hospital Anxiety and Depression Scale questionnaire(Measured repeatedly during 24 months of follow-up in the longitudinal part of the study.)
- Number of deceased patients due to all-cause mortality(During 24 months of follow-up in the longitudinal part of the study.)
- Number of AAA-related adverse events in EVAR patients(During 24 months of follow-up in the EVAR patients of the longitudinal part of the study.)
- Number of patients with cardiovascular events(Cross-sectionally and during 24 months of follow-up in the longitudinal part of the study.)
研究者
Isabella Kardys
Principal investigator, associate professor
Erasmus Medical Center