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COVID-19NCT04397939

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

An observational study of COVID-19 and Myocardial Reperfusion Injury, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Any age
How many people
4,695 participants
Where
1 siteUnited States
Study dates
8 May 2020to 1 Mar 2022
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • Laboratory confirmed COVID-19

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mount Sinai Hospital

    New York, New York, 10029

Other trials in United States

About this study

Official title: 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.

Read the 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.

Keywords
COVID-19, Myocardial Injury, Cardiovascular Disease, Cardiac Troponin
Medical subject headings
COVID-19, Myocardial Reperfusion Injury, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04397939
Study groupRoleWhat they receive
Patients with Acute Cardiac InjuryPatients with acute cardiac injury
Patients without cardiac injuryPatients without cardiac injury
Patients with Chronic Cardiac InjuryPatients with chronic cardiac injury

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Death

    Number of deaths at 6 months follow up

    Measured: 6 months

Secondary outcomes (3)
  1. Number of Participants With Pulmonary Embolism

    Pulmonary embolism rate as assessed by number of participants with pulmonary embolism

    Measured: up to 6 months

  2. Number of Participants With Acute Kidney Injury

    Acute injury rate as assessed by number of Participants with acute kidney injury

    Measured: up to 6 months

  3. Number of Admissions to the Intensive Care

    Admission to the intensive care

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2020
  2. Study start8 May 2020
  3. Primary completion1 Mar 2022
  4. Study completion1 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
4,695 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04397939
Sponsor's protocol ID
GCO 20-0965
Status last verified
Mar 2024
First submitted
19 May 2020
Last updated
8 Mar 2024
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

    PubMed 31986264
  • Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

    PubMed 32031570
  • Guo T, Fan Y, Chen M, Wu X, Zhang L, He T, Wang H, Wan J, Wang X, Lu Z. Cardiovascular Implications of Fatal Outcomes of Patients With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):811-818. doi: 10.1001/jamacardio.2020.1017.

    PubMed 32219356
  • Shi S, Qin M, Shen B, Cai Y, Liu T, Yang F, Gong W, Liu X, Liang J, Zhao Q, Huang H, Yang B, Huang C. Association of Cardiac Injury With Mortality in Hospitalized Patients With COVID-19 in Wuhan, China. JAMA Cardiol. 2020 Jul 1;5(7):802-810. doi: 10.1001/jamacardio.2020.0950.

    PubMed 32211816
  • Kini A, Cao D, Nardin M, Sartori S, Zhang Z, Pivato CA, Chiarito M, Nicolas J, Vengrenyuk Y, Krishnamoorthy P, Sharma SK, Dangas G, Fuster V, Mehran R. Types of myocardial injury and mid-term outcomes in patients with COVID-19. Eur Heart J Qual Care Clin Outcomes. 2021 Sep 16;7(5):438-446. doi: 10.1093/ehjqcco/qcab053.

    PubMed 34458912

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