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临床试验/NCT02204774
NCT02204774已完成不适用

Is Obstructive Sleep Apnoea a Risk Factor for Thoracic Aortic Aneurysm Expansion? A Prospective Cohort Study.

University of Zurich1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2014年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
230
试验地点
1
主要终点
Aneurysm expansion rate

研究概览

简要总结

The objective of this prospective cohort study in patients with a known thoracic aortic aneurysm is to test the hypothesis that yearly aneurysm progression rate is higher in patients with obstructive sleep apnoea (OSA) compared to patients without OSA, and that the need for aortic operation or proven or presumed death from aortic rupture or dissection happens more often in patients with thoracic aortic aneurysm and OSA compared to patients without OSA.

详细描述

Thoracic aortic aneurysm An aortic aneurysm is defined as a localised dilatation of the aorta, which includes all three layers of the vessel, intima, media and adventitia. The incidence of thoracic aortic aneurysm is estimated to be six to ten cases per 100,000 patient years, most commonly occurring in the sixth and seventh decade of life. Thoracic aortic aneurysms are two to four times more commonly found in males than in females. Sixty percent of thoracic aortic aneurysms involve the ascending aorta, 40% the descending aorta, and 10% involve the thoraco-abdominal aorta. The pathogenesis and natural history as well as the therapy of thoracic aortic aneurysms differ for each of these segments.

Thoracic aneurysms of the ascending aorta are considered to result from cystic degeneration of the media layer, a process associated with weakening of the aortic wall. Cystic medial degeneration occurs with aging, but seems to be increased in some families and with arterial hypertension. Other risk factors which have been suggested to be associated primarily with thoracic aneurysm formation of the descending aorta are the same as those for atherosclerosis (e.g. hypertension, smoking and hypercholesterolemia). Whether atherosclerosis itself is a prerequisite for aortic aneurysm development is a matter of debate. A multifactorial, non-atherosclerotic cause such as a defect in vascular structural proteins and breakdown of extracellular matrix proteins in combination with increased mechanical stress has been postulated as the most likely mechanism for thoracic aneurysm formation.

Transthoracic echocardiography, computed tomography or MR angiography are recommended for serial re-evaluation of a thoracic aortic aneurysm.

Natural history data on thoracic aortic aneurysms is scarce; however, aneurysm diameter has been shown to increase by 1 to 10 mm per year. The rate of expansion is related to the diameter of the aneurysm with larger aneurysms expanding faster; the findings of an early cohort study on the natural course of thoracic aortic aneurysms found a yearly expansion of 7.9mm in aneurysms >50mm, compared to 1.7mm in aneurysms ≤50mm.

In several series of patients, aneurysm rupture occurred in 32% to 68% of medically treated patients. The most important identified risk factor for rupture seems to be the size of the aneurysm; the yearly rate of dissection or rupture ranges from 2%, to 3%, to 7%, for thoracic aortic aneurysms less than 50 mm, 50-59 mm, and ≥60 mm in diameter, respectively. Expansion rate per year, male gender, hypertension, systemic steroid therapy and inflammation are other factors associated with increased risk of aneurysm rupture.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Patients on continuous positive airway pressure (CPAP) therapy for OSA at baseline.
  • Patients with known central sleep apnoea.
  • Patients on morphine or other opioid medication, heroin addiction, alcohol addiction.
  • Patients with moderate or severe aortic regurgitation.
  • Patients with moderate or severe aortic stenosis.
  • Pregnant patients.

结局指标

主要结局

Aneurysm expansion rate

时间窗: three years

mm per year

次要结局

  • Death from proven or presumed aortic dissection/rupture(three years)
  • combined endpoint of operation (or fulfilling the criteria for operation)(three years)
  • endovascular repair because of rapid progression of thoracic aortic aneurysm(three years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Malcolm Kohler

Head, Division of Pneumology

University of Zurich

研究点 (1)

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