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

NCT04397939 | Completed Results

• 1 other identifier: GCO 20-0965
• Study Type: observational
• Target: 4,695
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Myocardial Reperfusion Injury; Cardiovascular Diseases

Keywords

COVID-19; Myocardial Injury; Cardiovascular Disease; Cardiac Troponin

Outcome Measures

Primary Outcomes (1)

• Number of Death

  Number of deaths at 6 months follow up

  6 months

Secondary Outcomes (3)

• Number of Participants With Pulmonary Embolism

  up to 6 months

• Number of Participants With Acute Kidney Injury

  up to 6 months

• Number of Admissions to the Intensive Care

  up to 6 months

Study Arms (3)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Laboratory confirmed COVID-19

You may not qualify if:

• None

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Related Publications (5)

• 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.

  PMID: 31986264 BACKGROUND

• 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.

  PMID: 32031570 BACKGROUND

• 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.

  PMID: 32219356 BACKGROUND

• 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.

  PMID: 32211816 BACKGROUND

• 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.

  PMID: 34458912 RESULT

MeSH Terms

Conditions

COVID-19; Myocardial Reperfusion Injury; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Cardiomyopathies; Heart Diseases; Myocardial Ischemia; Vascular Diseases; Reperfusion Injury; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The time of being diagnosed as COVID-19 might not reflect the time of being infected. Troponin was not systematically assessed in all patients with COVID-19 referred to our health system, with the consequent risk of selection bias and possible overestimation of the burden of myocardial injury.

Results Point of Contact

• Title: Annapoorna S Kini, M.D.
• Organization: Mount Sinai Hospital

annapoorna.kini@mountsinai.org

(212) 241-4181

Study Officials

• Annapoorna Kini, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Catheterization Laboratory

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 21, 2020
• Study Start: May 8, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 8, 2024
• Results First Posted: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)