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临床试验/NCT03233087
NCT03233087招募中不适用

Diagnosis and Prognosis for Aortic Aneurysm aNd Dissection in Anzhen

Beijing Institute of Heart, Lung and Blood Vessel Diseases1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2014年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,500
试验地点
1
主要终点
Prognosis of each participant

研究概览

简要总结

The registry study aims to determine serial biomarkers to diagnosis and prognosis of aortic aneurysm/aortic dissection.

详细描述

The study aims to investigate the role of candidate biomarkers in the diagnosis and prognosis of AA and AD. In the diagnosis part, we begin with a discovery phase where individually matched case-control study. Patients within each disease outcomes (i.e. AD, AMI, PE, AA without AD and healthy controls) are age and sex matched and retrospectively included.In the prognosis part of the study, patients with confirmed AA and AD are enrolled. The primary outcome is the all-cause mortality based on the death certificates. The secondary outcome is the in-hospital mortality according to the patients'medical records.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Retrospective
  • All patients who were referred to the surgical service for evaluation and management of aortic dissection were included.
  • Perspective
  • Patients with initial suspicion of having AAD were perspectively enrolled.

排除标准

  • Retrospective
  • Patients who received packed red blood cells, whole blood, or platelets less than 10 days before the blood sample was taken;
  • Patients with aortic trauma, pseudo aneurysm, history of heart failure, renal dysfunction, severe pulmonary diseases, or active cancer;
  • Patients who entered the hospital for checkups after surgery.
  • Perspective
  • Patients in whom there is little or no suspicion of a life-threatening disease;
  • Patients with confirmed acute myocardial infarction,angina or pulmonary embolism
  • The symptoms were clearly not related to AD (e.g. pleurisy, pneumonia, acute abdominal diseases).

结局指标

主要结局

Prognosis of each participant

时间窗: These data is collected from the cases' medical record or during follow-up visit at 2-4 years after discharge.

Prognosis information including all-cause mortality and in-hospital mortality.

Dignosis of each participant

时间窗: These data is collected from the cases' medical record in an average of 6 month after the sample recruiting

1. Patients with Aneurysm/Dissection had image information from ultrasound cardiograms and computed tomography to confirm the final diagnosis. 2. AMI if they had chest pain lasting \>20 min, diagnostic serial ECG changes comprising new pathological Q waves or ST-segment and T-wave changes, and a plasma creatine kinase-MB elevation greater than twice the normal level or cardiac troponin I (cTnI) level greater than 0.1 ng/mL. 3. Diagnosis of PE was confirmed by positive spiral computed tomography or pulmonary angiography, a high probability on ventilation perfusion scintigraphy, or a proximal deep vein thrombosis documented on compression ultrasonography or angiography.

次要结局

未报告次要终点

研究者

发起方
Beijing Institute of Heart, Lung and Blood Vessel Diseases
申办方类型
Other
责任方
Sponsor

研究点 (1)

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