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临床试验/NCT04397939
NCT04397939已完成不适用

Association of Early Myocardial Injury With Major Adverse Outcomes in Patients With COVID-19

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 4,695 人开始时间: 2020年5月8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
4,695
试验地点
1
主要终点
Number of Death

研究概览

简要总结

The study will analyze the incidence, clinical outcomes and predictors of myocardial injury in a large patient population with COVID-19 treated in Mount Sinai Hospital (MSH) system. In addition, the study team will explore the association between high-sensitivity troponin I (TnI) levels and clinical characteristics, biomarkers, cardiac tests data and treatment approaches to uncover the potential mechanisms responsible for COVID-19 induced myocardial injury.

详细描述

The study team's understanding of diagnosis, treatment and outcomes of coronavirus disease 2019 (COVID-19) is rapidly evolving. First reports from China clearly indicate that older patients with underlying cardiovascular disease and/or cardiac risk factors demonstrate higher mortality rates. Most recent reports provided novel insights into the incidence of myocardial injury in COVID-19 patients and its association with adverse outcomes. In both studies, patients with myocardial injury manifested by elevated high-sensitivity troponin I (TnI) levels had significantly higher in-hospital mortality rates compared with those without myocardial injury, (59.6 and 8.9% (3) and 51 vs 4.5 %). Among patients with myocardial injury, higher levels of TnI were associated with higher mortality rates. While the highest mortality rates were observed in patients with elevated TnI and underlying cardiovascular disease (CVD), mortality rates were also considerable in patients with elevated TnI and without prior CVD. In contrast, patients with known cardiovascular disease without TnI elevation had more favorable outcomes. Cardiac injury was independently associated with an increased risk of mortality in patients with COVID-19. The arming reports clearly indicate that the data from larger populations from multiple centers are needed to further characterize and better understand the association between myocardial injury and adverse outcomes in COVID-19 patients.

II. STUDY AIM The aim of the proposed study is to analyze the incidence, clinical outcomes and predictors of myocardial injury in a large patient population with COVID-19 treated in Mount Sinai Hospital (MSH) system. In addition, the study team will explore the association between TnI levels and clinical characteristics, biomarkers, cardiac tests data and treatment approaches to uncover the potential mechanisms responsible for COVID-19 induced myocardial injury.

III. STUDY POPULATION By October 2020, there have been 4,695 COVID-19 positive patients treated in the Mount Sinai Hospital (MSH) and more than 1,1000 patients with COVID-19 had been healed and discharged. All consecutive patients admitted to the MSH system from February 2020 to October 2020 with laboratory-confirmed COVID-19 will be included in the retrospective study.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Laboratory confirmed COVID-19

排除标准

  • 未提供

结局指标

主要结局

Number of Death

时间窗: 6 months

Number of deaths at 6 months follow up

次要结局

  • Number of Participants With Acute Kidney Injury(up to 6 months)
  • Number of Participants With Pulmonary Embolism(up to 6 months)
  • Number of Admissions to the Intensive Care(up to 6 months)

研究者

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

Annapoorna Kini

Director, Catheterization Laboratory

Icahn School of Medicine at Mount Sinai

研究点 (1)

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