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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Death | Number of deaths at 6 months follow up | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Pulmonary Embolism | Pulmonary embolism rate as assessed by number of participants with pulmonary embolism | up to 6 months |
| Number of Participants With Acute Kidney Injury |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Annapoorna Kini, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31986264 | Background | 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. | |
| 32031570 |
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Patients with laboratory-confirmed COVID-19 who had a hospital encounter within the Mount Sinai Health System (New York City) between 27 February 2020 and 15 October 2020 were evaluated for inclusion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Without Cardiac Injury | If cardiac troponin was normal on first assessment and subsequently elevated with ≤50% variation, patients were considered as not having a myocardial injury |
| FG001 | Patients With Chronic Myocardial Injury | Chronic myocardial injury was considered if cardiac troponin was elevated on both first and subsequent assessments with ≤20% variation |
| FG002 | Patients With Acute Cardiac Injury | Acute myocardial injury was considered if (i) cardiac troponin was normal on first assessment and subsequently elevated with >50% variation, or (ii) cardiac troponin was elevated on both first and subsequent assessments with >20% variation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Without Cardiac Injury | If cardiac troponin was normal on first assessment and subsequently elevated with ≤50% variation, patients were considered as not having a myocardial injury |
| BG001 | Patients With Chronic Myocardial Injury |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Death | Number of deaths at 6 months follow up | Posted | Count of Participants | Participants | 6 months |
|
6 months
Retrospective chart review - Only death information obtained.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Without Cardiac Injury | If cardiac troponin was normal on first assessment and subsequently elevated with ≤50% variation, patients were considered as not having a myocardial injury |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annapoorna S Kini, M.D. | Mount Sinai Hospital | (212) 241-4181 | annapoorna.kini@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2021 | Mar 14, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D015428 | Myocardial Reperfusion Injury |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Acute injury rate as assessed by number of Participants with acute kidney injury
| up to 6 months |
| Number of Admissions to the Intensive Care | Admission to the intensive care | up to 6 months |
| 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. |
| 32219356 | 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. |
| 32211816 | 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. |
| 34458912 | Result | 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. |
Chronic myocardial injury was considered if cardiac troponin was elevated on both first and subsequent assessments with ≤20% variation |
| BG002 | Patients With Acute Cardiac Injury | Acute myocardial injury was considered if (i) cardiac troponin was normal on first assessment and subsequently elevated with >50% variation, or (ii) cardiac troponin was elevated on both first and subsequent assessments with >20% variation |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Smoking, active/former | Count of Participants | Participants |
|
| Asthma | Count of Participants | Participants |
|
| Chronic Obstructive Pulmonary Disease (COPD) | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Chronic kidney disease | Count of Participants | Participants |
|
| Coronary artery disease | Count of Participants | Participants |
|
| Atrial fibrillation | Count of Participants | Participants |
|
| Heart failure | Count of Participants | Participants |
|
| Fever (T > 38.0°C) | Count of Participants | Participants |
|
| Tachycardia (>100 beats/min) | Count of Participants | Participants |
|
| Tachypnoea (≥22 breaths/min) | Count of Participants | Participants |
|
| Hypotension (Systolic Blood Pressure < 100 mmHg) | Count of Participants | Participants |
|
| O2 saturation | Median | Inter-Quartile Range | percent |
|
| White blood cell count | Median | Inter-Quartile Range | 10^3 cells/μL |
|
| Neutrophil | Median | Inter-Quartile Range | percent of cells |
|
| Lymphocyte | Median | Inter-Quartile Range | percent of cells |
|
| Haemoglobin | Median | Inter-Quartile Range | g/dL |
|
| Platelet | Median | Inter-Quartile Range | 10^3 cells/μL |
|
| C-reactive protein | Median | Inter-Quartile Range | mg/L |
|
| D-dimer | Median | Inter-Quartile Range | μg/mL |
|
| Ferritin | Median | Inter-Quartile Range | ng/mL |
|
| Blood urea nitrogen | Median | Inter-Quartile Range | mg/dL |
|
| Creatinine | Median | Inter-Quartile Range | mg/dL |
|
| OG002 | Patients With Acute Cardiac Injury | Acute myocardial injury was considered if (i) cardiac troponin was normal on first assessment and subsequently elevated with >50% variation, or (ii) cardiac troponin was elevated on both first and subsequent assessments with >20% variation |
|
|
| Secondary | Number of Participants With Pulmonary Embolism | Pulmonary embolism rate as assessed by number of participants with pulmonary embolism | Posted | Count of Participants | Participants | up to 6 months |
|
|
|
| Secondary | Number of Participants With Acute Kidney Injury | Acute injury rate as assessed by number of Participants with acute kidney injury | Posted | Count of Participants | Participants | up to 6 months |
|
|
|
| Secondary | Number of Admissions to the Intensive Care | Admission to the intensive care | Posted | Number | admissions to ICU | up to 6 months |
|
|
|
| 417 |
| 3,208 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Patients With Chronic Myocardial Injury | Chronic myocardial injury was considered if cardiac troponin was elevated on both first and subsequent assessments with ≤20% variation | 137 | 319 | 0 | 0 | 0 | 0 |
| EG002 | Patients With Acute Cardiac Injury | Acute myocardial injury was considered if (i) cardiac troponin was normal on first assessment and subsequently elevated with >50% variation, or (ii) cardiac troponin was elevated on both first and subsequent assessments with >20% variation | 552 | 1,168 | 0 | 0 | 0 | 0 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
| D015427 | Reperfusion Injury |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |