Myocardial Injury and Major Adverse Outcomes in Patients With COVID-19

March 7, 2024 updated by: Annapoorna Kini, Icahn School of Medicine at Mount Sinai

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

4695

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Laboratory confirmed COVID-19

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Patients without cardiac injury
Patients with Acute Cardiac Injury
Patients with acute cardiac injury
Patients with Chronic Cardiac Injury
Patients with chronic cardiac injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Death
Time Frame: 6 months
Number of deaths at 6 months follow up
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Pulmonary Embolism
Time Frame: up to 6 months
Pulmonary embolism rate as assessed by number of participants with pulmonary embolism
up to 6 months
Number of Participants With Acute Kidney Injury
Time Frame: up to 6 months
Acute injury rate as assessed by number of Participants with acute kidney injury
up to 6 months
Number of Admissions to the Intensive Care
Time Frame: up to 6 months
Admission to the intensive care
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Annapoorna Kini, MD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2020

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 20-0965

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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