The Occurrence of Abdominal Aortic Aneurysms in Patients With Ruptured Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 233
- 试验地点
- 1
- 主要终点
- Occurrence of AAA
研究概览
简要总结
Rationale: Aneurysms of different types are known to be associated. In literature, concurrence of intracranial- and aortic aneurysms is described. Screening for aortic aneurysms (AA) in patients with intracranial aneurysms (IA) or aneurysmal subarachnoid haemorrhage (aSAH) could be cost-effective and of significant importance to decrease morbidity and mortality. The available literature on the association between the two types of aneurysms is sparse and in general of poor methodological quality. This protocol presents a study to more adequately evaluate the association between IA and AA.
Objective: To investigate the occurrence of abdominal aortic aneurysms (AAA) in patients who experienced aSAH.
Study design: This single cohort prospective study will include patients who experienced aSAH. The study participants will receive an abdominal ultrasound of the aorta to detect an AAA.
Study population: aSAH patients from a prospective cohort trial in the Netherlands.
Main study parameters/endpoints: The primary outcome, which will be investigated in the here above described study population, is the number of AAA detected on abdominal ultrasound.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will not receive an intervention, but only a diagnostic imaging without radiation. The burden associated with this study are considered minimal and the risks negligible. An abdominal ultrasound is a non-invasive diagnostic method with no risks for the participant. The only possible existing burden to the participant is travel and appointment time with a risk of detecting an abdominal aortic aneurysm or other (occult) intra-abdominal pathologies. When an aneurysm, sub-aneurysm or other intra-abdominal pathology is detected, surveillance or treatment according to standard of care and guidelines will follow.
详细描述
This study will be a prospective single cohort study.
During the period of the study, all aSAH patients (from another prospective cohort trial) will be screened for inclusion eligibility. Eligible patients will be included as subjects in this study. Study subjects will receive an abdominal ultrasound (US) focused on the aorta. Detecting an AAA on abdominal US will result in the daily standard of care for AAA, including surveillance and possible treatment by medication, intervention or surgery.
Study sites This study will be conducted by the Department of Surgery in the main study location University Medical Center Leiden (LUMC) in collaboration with University Neurosurgical Center Holland (UNCH). Eligibility screening and inclusion will be performed by the LUMC.
To answer the research questions of this study, the US laboratory of the LUMC will perform US on the included patients.
The clinical (neurovascular) centers who included patients in the SPARTA trial are:
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
- •In order to be eligible to participate in this study, a participant must meet all of the following criteria:
- •Patient is a study subject of the trial: Study on Prognosis of Acutely RupTured Aneurysms (SPARTA)(12)
- •Inclusion at least one year after aSAH
- •Written informed consent
- •By being a study subject of the SPARTA trial, the following criteria are applicable:
- •Confirmed diagnosis of SAH on CT-scan or lumbar puncture (in the presence of a negative CT-scan)
- •IA related SAH as confirmed with radiological imaging
- •Age 18 years or older at presentation
- •Written informed consent for the SPARTA-trial
排除标准
- •A potential participant who meets any of the following criteria will be excluded from participation in this study:
- •Patient is not a study subject of the SPARTA trial
- •Patient has Loeys-Dietz-, Marfan- or Ehlers-Danlos syndrome
研究组 & 干预措施
Patients with aSAH from the SPARTA trial
All aSAH patients from a large prospective cohort trial in the Netherlands will be screened for eligibility(12). The Study on Prognosis of Acutely RupTured Aneurysms (SPARTA) is an observational prospective cohort trial conducted in the Netherlands in several clinical centres. The aim of this study is to evaluate the long-term clinical outcome of aSAH patients who underwent neurosurgical- or endovascular treatment for their ruptured IA. The study has a population of around 900 patients. Because of the lethality of aSAH, a large proportion of this study population will be diseased or heavily incapacitated.
结局指标
主要结局
Occurrence of AAA
时间窗: 1 year
Main study parameter/endpoint The primary endpoint of this study will be the occurrence rate of AAA in the study population. This occurrence rate will be calculated as the proportion of all performed ultrasounds in the study group (N; %).
次要结局
- Risk factors for AAA in aSAH patients(1 year)
研究者
Jeroen J.W.M. Brouwers MD PhD
Principal Investigator
Leiden University Medical Center