Purpose

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.

Conditions

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Laboratory confirmed COVID-19

Exclusion Criteria

  • None

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
Patients with Acute Cardiac Injury Patients with acute cardiac injury
Patients without cardiac injury Patients without cardiac injury
Patients with Chronic Cardiac Injury Patients with chronic cardiac injury

Recruiting Locations

More Details

NCT ID
NCT04397939
Status
Completed
Sponsor
Icahn School of Medicine at Mount Sinai

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.