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临床试验/NCT03788980
NCT03788980终止不适用

Risk Factors for Complications After Carotid Endarterectomy: A Multicenter International Observational Study

Ohio State University2 个研究点 分布在 2 个国家目标入组 10 人开始时间: 2018年4月13日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
10
试验地点
2
主要终点
Complication rate

研究概览

简要总结

This study may determine the incidence of complications that occur after patients undergo a surgery called Carotid Endarterectomy (CEA), which is a surgery that aims to decrease the risk of strokes in patients with a condition called carotid stenosis. Medical records will be accessed to find any information pertaining to postoperative complications. Additionally, it may determine the cognitive dysfunction of patients undergoing CEA, assessed by Mini Mental Status Examination (MMSE).

详细描述

This is a multicenter prospective observational study; data will be collected from two sites: the lead site in Columbus, Ohio, USA and an international site in Girona, Spain for a total of 354 patients. The objective of this study is to determine the incidence of complications that occur after patients undergo a surgery called Carotid Endarterectomy (CEA), which is a surgery that aims to decrease the risk of strokes in patients with a condition called carotid stenosis. Patients who undergo CEA are at increased risk of cardiovascular complications because of the high incidence of coexisting heart disease, high blood pressure, and diabetes. Common complications that occur after CEA are wound hematoma (collection of blood at the wound) and intracerebral hemorrhage (bleeding in the brain). Medical records will be accessed to find any information pertaining to postoperative complications. Another objective of this study is to determine the cognitive dysfunction of patients undergoing CEA. This will be measured by a Mini Mental Status Examination (MMSE) which will occur in person before the surgery and 30 days after the surgery over the phone. This study may provide data that will help identify how to optimize recovery for future CEA patients.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Patients males or females, 18 years of age and older
  • Scheduled to undergo Carotid Endarterectomy

排除标准

  • Pregnant women
  • Incarcerated individuals
  • Patients not able to consent for themselves
  • Any disease or condition deemed by the investigator to disqualify the patient
  • Participating in any interventional clinical trial

结局指标

主要结局

Complication rate

时间窗: 30 days

Incidence of postoperative complications and identify the associated risk factors.

次要结局

  • Cognitive Dysfunction(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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