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临床试验/NCT03786965
NCT03786965Unknown不适用

Evaluating of Role of Myeloperoxidase in Prediction of Outcomes of Cardiac Surgery Procedures.

St. Petersburg State Pavlov Medical University2 个研究点 分布在 2 个国家目标入组 2,000 人开始时间: 2018年12月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
2
主要终点
Stroke.

研究概览

简要总结

The main objection is to investigate molecular biology of myocardial damage during cardiac surgery procedures.

详细描述

To assess outcomes after cardiac surgery procedures. To investigate serum level of myeloperoxidase, morphology of left atrium appendage, to perform genetic analysis and cell biology.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • ischemic heart disease with indications for operation
  • valve disease with indications for operation
  • ischemic heart disease combined with valve disease with indications for operation

排除标准

  • patient refusal

结局指标

主要结局

Stroke.

时间窗: within 30 days after procedure.

Stroke (MRI changes or corresponding neurologist record).

Infection or febrile.

时间窗: within 30 days after procedure.

Infection or febrile (t\> 37 or CRP elevation or long regeneration of surgical wound).

Respiratory dysfunction.

时间窗: within 30 days after procedure.

Respiratory dysfunction (pulmonary ventilation longer than 2 days).

Death within 30 days after procedure.

时间窗: within 30 days after procedure.

Death within 30 days after surgical procedure.

Acute myocardial infarction.

时间窗: within 30 days after procedure.

Acute myocardial infarction (ST-changes with troponin I \> 10 ng/ml).

Renal dysfunction.

时间窗: within 30 days after procedure.

Renal dysfunction if serum creatinine greater than 25% of upper reference range.

Arrhythmia

时间窗: within 30 days after procedure.

Any type of arrhythmia including AV-block.

次要结局

未报告次要终点

研究者

发起方
St. Petersburg State Pavlov Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aleksandr Nemkov

PhD

St. Petersburg State Pavlov Medical University

研究点 (2)

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