跳至主要内容
临床试验/NCT05392088
NCT05392088招募中不适用

Characterization and Prognostic Role of Myocardial Injury in Patients With COVID-19. The CardioCOVID Gemelli Study.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2022年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,500
试验地点
1
主要终点
To identify the clinical predictors of myocardial injury

研究概览

简要总结

The present retrospective and prospective observational study aims at evaluate the clinical predictors of myocardial injury in patients hospitalized for COVID-19 infection since the introduction of vaccines that could allow the development of predictive models as well as help clinicians in the early assessment of the risk of myocardial injury and the prevention of the associated unfavourable outcomes.

Furthermore, this study will characterize the cardiovascular outcomes in the post-acute COVID-19 phase, and it will evaluate for the first time the long-term clinical outcomes of patients who experienced myocardial injury, possibly paving the way for the implementation of specific therapies aiming to reduce the cardiovascular risk and the long- term sequelae of COVID-19.

详细描述

Background:

Coronavirus disease-2019 (COVID-19) is a global pandemic caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that is resulting in substantial morbidity and mortality (1). Of interest, a significant proportion of patients presenting with COVID-19 infection and requiring hospitalization demonstrate biomarker evidence of myocardial injury (defined as elevation in circulating cardiac troponin levels), which has been shown to be associated with increased risk of in-hospital morbidity (i.e.: rate of non- invasive and invasive ventilation, access to intensive care unit, length of hospitalization, use of glucocorticoids or antibiotics) and mortality (2-6). The pathogenesis of myocardial injury in COVID-19 is still unclear, with proposed mechanisms that include cytokine-mediated damage, oxygen supply-demand imbalance, ischemic injury from microvascular thrombi formation and direct viral invasion of the myocardium (7-9). Notably, the clinical predictors of myocardial injury in COVID-19 infection are still unknown, and, therefore, there is lack of therapeutic opportunities to prevent or reduce myocardial injury and the related-unfavourable outcomes.

Moreover, the post-acute sequelae of COVID-19 could potentially involve the pulmonary and several extrapulmonary organs, including the cardiovascular system (10). A few studies <<to date have investigated cardiovascular outcomes in the post-acute phase of the COVID-19, and most with a short duration of follow-up and a narrow selection of cardiovascular outcomes (11-13). Therefore, a comprehensive assessment of post-acute COVID-19 sequelae on the cardiovascular system is still missing and, of interest, studies addressing the post-acute COVID-19 sequelae in patients who developed myocardial injury during COVID-19 infection are lacking (14).

Given these shortcomings in this evolving area of clinical research, a comprehensive characterization of myocardial injury in patients with COVID-19 infection and the identification of clinical predictors for its occurrence could allow the development of predictive models, thus helping clinicians in the disease phenotyping and the early assessment of the risk of unfavourable outcome and improving a fast determination of most appropriate treatments and clinical paths, efficient planning and use of clinical resources in terms of treatment type and units (such as intensive care or coronary intensive care). In addition, the identification of clinical predictors and/or protective factors for myocardial injury in COVID-19 infection may pave the way for the development of specific therapeutic strategies aiming to reduce the impact of myocardial injury on COVID-19-related morbidity and mortality. Finally, assessing the long-term cardiovascular impact of myocardial injury in COVID-19 infection could help clinicians in the prognostic stratification and the choice of therapeutic strategies in the post-acute COVID-19 phases, possibly identifying those patients that may need a more aggressive therapy and a closer follow-up.

OBJECTIVES

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years;
  • Overt COVID-19 infection (molecular nasopharyngeal swab positive for SARS-CoV-2 ≥1);
  • Patient with at least a high sensitivity Troponin I measured during hospitalization course.
  • Available data on vaccination.
  • Verbal informed consent

排除标准

  • Age <18 years;
  • Patient in whom at least one high sensitivity Troponin I value measured during the course of hospitalization is not available.
  • No data available on vaccination status.

结局指标

主要结局

To identify the clinical predictors of myocardial injury

时间窗: Up to 30 days

Th occurence of clinical predictors of myocardial injury during the index hospitalization (defined as at least one value of hs-cTnI \>99th percentile upper reference limit) will be evaluated using univariable and multivariable logistic regression models. Results will be expressed as odds ratio (OR) with 95% confidence interval (CI).

次要结局

  • To assess the correlation between myocardial injury and in-hospital complications(Up to 30 days)
  • To assess if myocardial injury can predict MACE at 1-year follow-up(1 year)

研究者

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

MONTONE ROCCO ANTONIO

IRCCS Researcher

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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