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临床试验/NCT02716402
NCT02716402已完成不适用

Cyanotic Congenital Heart Disease: Prevalence of Pulmonary and Cerebral Thrombi-embolic Events

Annette Schophuus Jensen2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年11月最近更新:
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
50
试验地点
2
主要终点
Pulmonary and cerebral thrombosis

研究概览

简要总结

The purpose of the study is to examine previously examined patients with cyanotic congenital heart disease to assess how many of the patients have obtained additional blood clots since they were examined 8 years ago.

详细描述

Patients with cyanotic congenital heart disease have reduced oxygen content in their blood due to abnormal connection between the heart's right and left sides. The reduced oxygenation of the blood affects several organs of the body and a common complications to the disease is blood clots. Despite the patients are young and do not have typical risk factors, previous studies have shown, that they have a very high prevalence of thrombosis in the lungs and brain.

The reason for the increased prevalence of blood clots is not known. A previous study investigated the prevalence of blood clots systematically in patients with cyanotic congenital heart disease and found that approximately 30-40% of the patients had had a clot in the lung or brain. Thus, the study could not predict, when the patient had had a thrombotic event, and most of the patients did not previously had imaging performed. Therefore the aim of this study is to re-examine previously examined cyanotic patients regardless of previous medical history, to assess how many of the patients have obtained additional blood clots since they were examined 8 years ago.

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

入选标准

  • Patients with cyanotic congenital heart disease who have previously participated in the study 'cyanotic congenital heart disease: Hemostatic abnormalities and clinical manifestations' (H-KF-2006-4068).
  • Clinically stable

排除标准

  • Patients who are not guardians for themselves (not adult).
  • Age <18 years.

研究组 & 干预措施

Cyanotic congenital heart disease

Other

Patients who previously have been examined with cerebral MRI and V/Q SPECT/CT will be re-examined with cerebral MRI and V/Q SPECT/CT

干预措施: Cerebral MRI and V/Q SPECT/CT (Radiation)

结局指标

主要结局

Pulmonary and cerebral thrombosis

时间窗: Through study completion, an average of 1 year

Numbers and locations of cerebral and and pulmonary thrombosis, which will be compared with previous examinations

次要结局

  • The total numbers of white matter hyper intensity lessons (WMHL)(Through study completion, an average of 1 year)
  • The size of the white matter hyper intensity lessons (WMHL)(Through study completion, an average of 1 year)

研究者

发起方
Annette Schophuus Jensen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Annette Schophuus Jensen

PhD MD

Rigshospitalet, Denmark

研究点 (2)

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