Vascular Changes in Patients With Aotic Isthmus Stenosis After Interventional Therapy Using Ballon Angioplasty or Stent Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- change in central systolic blood pressure (BP) (mmHg) measured using pulse wave analysis
研究概览
简要总结
This controlled clinical study investigates arterial blood pressure and vascular remodling before and 4 weeks after catheter interventional treatment of re-stenosis of the aortic isthmus (Recoarctatio Aortae).
详细描述
Patients with treated aortic isthmus stenosis during their first year of life often develop a Recoarctatio Aortae (re-stenosis of the aortic isthmus) in the long term followed by arterial hypertension. The Recoarctatio Aortae can be treated during a cather intervention by balloon dilatation or stent implantation. Patients with arterial hypertension often develop vascular remodeling with increased central systolic blood pressure and increased pulse pressure. Vascular remodling predics cardiovascular events and increases mortality. Vascular remodeling can be assessed non-invasively by using scanning laser doppler flowmetry (SLDF)), pulse wave analysis and measurement of flow-dependent vasodilation. In this controlled clinical study we investigate arterial blood pressure and vascular remodling before and 4 weeks after catheter interventional treatment of Recoarctatio Aortae.
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
- 12 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female persons with Recoarctatio Aortae and planned interventional therapy (balloon dilatation or stent implantation)
- •adequate contraceptive methods in females with childbearing potential
排除标准
- •other secondary causes for hypertension
- •treatment resistent arterial hypertension or uncontrolled hypertension (office BP ≥ 180/110 mmHg)
- •history of hypertensive enzephalopathy or intracerebral bleeding
- •diabetes mellitus
- •known renal, respiratory, hepatic, gastrointestinal, endocrine, metabolic, immunolic, hematologic, oncologic, neurologic or psychiatric diseases besides the diagnosis of artoic isthmus stenosis
- •one of the following diseases or conditions during the last 6 months: myocardial infaction, instable angina pectoris, cardiac insufficiency
- •pregnant or lactating woman or inadequate contraception (pearl-index ≥ 1%)
- •participation in another clinical study
- •drug or medication abuse
- •inadequate adherence or other condition preventing the patient from study participation (in the eyes of the treating physician)
结局指标
主要结局
change in central systolic blood pressure (BP) (mmHg) measured using pulse wave analysis
时间窗: 4 weeks
change in central systolic blood pressure (BP) (mmHg) between baseline and 4 weeks post intervention
次要结局
- change in retinal capillary flow (AU) measured using Scanning Laser Doppler Flowmetry(4 weeks)
- change in augmentation index (-) measured using pulse wave analysis(4 weeks)
- change in central diastolic blood pressure (BP) (mmHg) measured using pulse wave analysis(4 weeks)
- change in systolic and diastolic 24 hour ambulatory BP (mmHg)(4 weeks)
- change in systolic and diastolic office BP (mmHg)(4 weeks)
- change in central pulse pressure measured (mmHg) using pulse wave analysis(4 weeks)
- change in pulse wave velocity (m/s)(4 weeks)
- change in retinal arteriolar wall to lumen ratio (-) measured using Scanning Laser Doppler Flowmetry(4 weeks)
- change in retinal capillary density measured using Scanning Laser Doppler Flowmetry(4 weeks)
- change in flow dependent vasodilation measured using the Unex Device(4 weeks)
研究者
Agnes Bosch
Dr. med. Agnes Bosch, Principal Investigator
University of Erlangen-Nürnberg Medical School