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临床试验/NCT03469388
NCT03469388已完成不适用

Arterial Stiffness, Blood Pressure and Cardiac Output Study; ABC-study A Prospective, Multidisciplinary Study of Arterial Stiffness Measures in Patients Treated for Aortic Aneurysms in Relation to Blood Pressure and Cardiac Output

Rijnstate Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年4月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
central blood pressure

研究概览

简要总结

Comparison of non-invasively obtained central blood pressure using SphygmoCor and invasively recorded central blood pressure in patients with an AAA that will be treated with EVAR.

详细描述

Primary objective of the first study: validation of non-invasive central pressure parameters in patients treated with EVAR against invasive measurements.

Objectives of subsequent studies: Do non-invasive central parameters change over time after EVAR? What is the influence of intraluminal thrombus (presence, amount, configuration) on non-invasive central pressure parameters (and other obtained parameters of arterial stiffness)? Prospective study with consecutive, eligible subject enrollment. All subjects will undergo the Endovascular Aneurysm repair procedure with an endovascular device. Subjects will be followed procedurally, at 6-8 weeks and 1 year post implantation.

This study is a collaboration of the following departments of the Vascular Center in the Rijnstate Hospital Arnhem: Vascular Surgery, Interventional radiology, Internal Vascular Medicine, Cardiology.

Patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair and who meet the study eligibility criteria may be screened for enrollment in the study. Up to 20 subjects will be enrolled .

Pre-procedural high resolution, contrast-enhanced CT scan evaluation to determine anatomical eligibility for enrollment will be performed within three months of the study procedure, according to standard care. Following EC/IRB approval of the study and the written informed consent form, patients will be screened for eligibility. Following informed consent, clinical characteristics will be reported (from hospital records). Per-procedural PWA measurements will be performed simultaneously with intravascular pressure measurements pre-implantation and after completion of the endocasular implantation. Subjects will be followed at 30 days and 1 year post-implantation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • •Male or female at least 18 years old;
  • •Informed consent form understood and signed and patient agrees to follow-up visits;
  • •Have a infrarenal abdominal aortic aneurysm (AAA) with maximum sac diameter ≥ 5.5cm, or an AAA ≥ 4.5 cm which has increased by > 1.0 cm in the past year with a scheduled endovascular intervention

排除标准

  • •Life expectancy < 2 years;
  • •Psychiatric or other condition that may interfere with the study;
  • •Participating in another clinical study, interfering on outcomes;
  • •Irregular pulse;
  • •Presence of extensive peripheral arterial disease (ABI < 0.9 or obstruction validated on imaging); dated less than 3 months prior to treatment
  • •Ruptured, leaking or mycotic aneurysm;

研究组 & 干预措施

elective EVAR patients

Experimental

Elective EVAR patients will be included in one arm only

干预措施: Pulse wave analyses; central blood presaure parameters (Diagnostic Test)

结局指标

主要结局

central blood pressure

时间窗: one week

comparison of invasively recorded and non-invsively estimated central blood pressure

次要结局

  • changes in arterial stiffness pre- and post EVAR(1 year)
  • influence of thrombus on arterial stiffness(1 year)
  • changes in arterial stiffness over time(1 year)

研究者

发起方
Rijnstate Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michel Reijnen

MD, PhD

Rijnstate Hospital

研究点 (1)

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