Cardiovascular Diseases, COVID-19, Myocardial Reperfusion Injury
Conditions
Keywords
COVID-19, Myocardial Injury, Cardiovascular Disease, Cardiac Troponin
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.
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.
Interventions
None listed
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Laboratory confirmed COVID-19
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Death | 6 months | Number of deaths at 6 months follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Pulmonary Embolism | up to 6 months | Pulmonary embolism rate as assessed by number of participants with pulmonary embolism |
| Number of Participants With Acute Kidney Injury | up to 6 months | Acute injury rate as assessed by number of Participants with acute kidney injury |
| Number of Admissions to the Intensive Care | up to 6 months | Admission to the intensive care |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 3,208 |
| Patients With Chronic Myocardial Injury Chronic myocardial injury was considered if cardiac troponin was elevated on both first and subsequent assessments with ≤20% variation | 319 |
| 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 | 1,168 |
| Total | 4,695 |
Baseline characteristics
| Characteristic | Total | Patients Without Cardiac Injury | Patients With Chronic Myocardial Injury | Patients With Acute Cardiac Injury |
|---|---|---|---|---|
| Age, Continuous | 64.7 years STANDARD_DEVIATION 16.5 | 60.9 years STANDARD_DEVIATION 16.2 | 74.1 years STANDARD_DEVIATION 13.5 | 72.6 years STANDARD_DEVIATION 14.2 |
| Asthma | 226 Participants | 171 Participants | 14 Participants | 41 Participants |
| Atrial fibrillation | 330 Participants | 135 Participants | 40 Participants | 155 Participants |
| Blood urea nitrogen | 17.0 mg/dL | 14.0 mg/dL | 39.0 mg/dL | 30.0 mg/dL |
| Body Mass Index (BMI) | 28.9 kg/m^2 STANDARD_DEVIATION 7.3 | 29.3 kg/m^2 STANDARD_DEVIATION 7.2 | 27.3 kg/m^2 STANDARD_DEVIATION 6.4 | 28.3 kg/m^2 STANDARD_DEVIATION 7.9 |
| Chronic kidney disease | 445 Participants | 145 Participants | 88 Participants | 212 Participants |
| Chronic Obstructive Pulmonary Disease (COPD) | 174 Participants | 91 Participants | 22 Participants | 61 Participants |
| Coronary artery disease | 600 Participants | 251 Participants | 83 Participants | 266 Participants |
| C-reactive protein | 106.5 mg/L | 95.4 mg/L | 108.3 mg/L | 136.9 mg/L |
| Creatinine | 1.0 mg/dL | 0.9 mg/dL | 1.7 mg/dL | 1.4 mg/dL |
| D-dimer | 1.5 μg/mL | 1.2 μg/mL | 2.6 μg/mL | 2.5 μg/mL |
| Diabetes | 1033 Participants | 590 Participants | 104 Participants | 339 Participants |
| Ferritin | 685.5 ng/mL | 608.5 ng/mL | 834.0 ng/mL | 853.0 ng/mL |
| Fever (T > 38.0°C) | 853 Participants | 610 Participants | 49 Participants | 194 Participants |
| Haemoglobin | 13.1 g/dL | 13.3 g/dL | 12.4 g/dL | 12.7 g/dL |
| Heart failure | 344 Participants | 113 Participants | 71 Participants | 160 Participants |
| Hypertension | 1613 Participants | 932 Participants | 155 Participants | 526 Participants |
| Hypotension (Systolic Blood Pressure < 100 mmHg) | 294 Participants | 139 Participants | 38 Participants | 117 Participants |
| Lymphocyte | 13.3 percent of cells | 14.3 percent of cells | 12.9 percent of cells | 10.2 percent of cells |
| Neutrophil | 78.6 percent of cells | 77.4 percent of cells | 80.0 percent of cells | 81.4 percent of cells |
| O2 saturation | 90.0 percent | 91.0 percent | 88.0 percent | 86.0 percent |
| Platelet | 206.0 10^3 cells/μL | 210.0 10^3 cells/μL | 174.0 10^3 cells/μL | 204.0 10^3 cells/μL |
| Race/Ethnicity, Customized African American | 1189 Participants | 748 Participants | 114 Participants | 327 Participants |
| Race/Ethnicity, Customized Asian | 224 Participants | 160 Participants | 10 Participants | 54 Participants |
| Race/Ethnicity, Customized Hispanic | 1361 Participants | 1013 Participants | 80 Participants | 268 Participants |
| Race/Ethnicity, Customized Other | 687 Participants | 470 Participants | 45 Participants | 172 Participants |
| Race/Ethnicity, Customized Unknown | 183 Participants | 142 Participants | 1 Participants | 40 Participants |
| Race/Ethnicity, Customized White | 1051 Participants | 675 Participants | 69 Participants | 307 Participants |
| Sex: Female, Male Female | 2052 Participants | 1441 Participants | 130 Participants | 481 Participants |
| Sex: Female, Male Male | 2643 Participants | 1767 Participants | 189 Participants | 687 Participants |
| Smoking, active/former | 1166 Participants | 749 Participants | 98 Participants | 319 Participants |
| Tachycardia (>100 beats/min) | 1775 Participants | 1207 Participants | 94 Participants | 474 Participants |
| Tachypnoea (≥22 breaths/min) | 1242 Participants | 679 Participants | 102 Participants | 461 Participants |
| White blood cell count | 7.4 10^3 cells/μL | 7.0 10^3 cells/μL | 7.6 10^3 cells/μL | 8.5 10^3 cells/μL |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 417 / 3,208 | 137 / 319 | 552 / 1,168 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Death
Number of deaths at 6 months follow up
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Without Cardiac Injury | Number of Death | 417 Participants |
| Patients With Chronic Myocardial Injury | Number of Death | 137 Participants |
| Patients With Acute Cardiac Injury | Number of Death | 552 Participants |
Secondary
Number of Admissions to the Intensive Care
Admission to the intensive care
Time frame: up to 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Without Cardiac Injury | Number of Admissions to the Intensive Care | 393 admissions to ICU |
| Patients With Chronic Myocardial Injury | Number of Admissions to the Intensive Care | 64 admissions to ICU |
| Patients With Acute Cardiac Injury | Number of Admissions to the Intensive Care | 325 admissions to ICU |
Secondary
Number of Participants With Acute Kidney Injury
Acute injury rate as assessed by number of Participants with acute kidney injury
Time frame: up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Without Cardiac Injury | Number of Participants With Acute Kidney Injury | 99 Participants |
| Patients With Chronic Myocardial Injury | Number of Participants With Acute Kidney Injury | 30 Participants |
| Patients With Acute Cardiac Injury | Number of Participants With Acute Kidney Injury | 107 Participants |
Secondary
Number of Participants With Pulmonary Embolism
Pulmonary embolism rate as assessed by number of participants with pulmonary embolism
Time frame: up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Without Cardiac Injury | Number of Participants With Pulmonary Embolism | 32 Participants |
| Patients With Chronic Myocardial Injury | Number of Participants With Pulmonary Embolism | 4 Participants |
| Patients With Acute Cardiac Injury | Number of Participants With Pulmonary Embolism | 22 Participants |