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

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ClinicalTrials.gov Identifier: NCT04397939
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Annapoorna Kini, Icahn School of Medicine at Mount Sinai

Brief Summary:
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.

Condition or disease
COVID-19 Myocardial Reperfusion Injury Cardiovascular Diseases

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 As of April 6, 2020, there have been 1,917 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 April 2020 with laboratory-confirmed COVID-19 will be included in the retrospective study.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Association of Early Myocardial Injury With Major Adverse Outcomes in Patients With COVID-19
Actual Study Start Date : May 8, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Group/Cohort
Patients with Cardiac Injury
Patients with cardiac injury
Patients without cardiac injury
Patients without cardiac injury



Primary Outcome Measures :
  1. Number of In-Hospital Death [ Time Frame: During hospitalization, average 2-3 weeks ]
    Number of death during hospitalization


Secondary Outcome Measures :
  1. Length of Stay [ Time Frame: During hospitalization, average 2-3 weeks ]
    Length of stay in the hospital

  2. Number of Successful Treatment [ Time Frame: During hospitalization, average 2-3 weeks ]
    Successful treatment will be defined by two consecutive negative tests for COVID-19



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive patients admitted to the MSH system from February 2020 to April 2020 with laboratory-confirmed COVID-19 will be included in the retrospective study
Criteria

Inclusion Criteria:

  • Laboratory confirmed COVID-19

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397939


Contacts
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Contact: Yuliya Vengrenyuk, PhD 212-241-0460 yuliya.vengrenyuk@mountsinai.org

Locations
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United States, New York
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Yuliya Vengrenyuk, PhD    212-241-0460    yuliya.vengrenyuk@mountsinai.org   
Principal Investigator: Annapoorna Kini, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Annapoorna Kini, MD Icahn School of Medicine at Mount Sinai
Publications:
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Responsible Party: Annapoorna Kini, Director, Catheterization Laboratory, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04397939    
Other Study ID Numbers: GCO 20-0965
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Annapoorna Kini, Icahn School of Medicine at Mount Sinai:
COVID-19
Myocardial Injury
Cardiovascular Disease
In-Hospital Death
Length of Stay
Additional relevant MeSH terms:
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Cardiovascular Diseases
Reperfusion Injury
Myocardial Reperfusion Injury
Wounds and Injuries
Vascular Diseases
Postoperative Complications
Pathologic Processes
Cardiomyopathies
Heart Diseases
Myocardial Ischemia