Trial Outcomes & Findings for Myocardial Injury and Major Adverse Outcomes in Patients With COVID-19 (NCT NCT04397939)
NCT ID: NCT04397939
Last Updated: 2024-03-08
Results Overview
Number of deaths at 6 months follow up
Recruitment status
COMPLETED
Target enrollment
4695 participants
Primary outcome timeframe
6 months
Results posted on
2024-03-08
Participant Flow
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.
Participant milestones
| Measure |
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
|
Patients With Chronic Myocardial Injury
Chronic myocardial injury was considered if cardiac troponin was elevated on both first and subsequent assessments with ≤20% variation
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
3208
|
319
|
1168
|
|
Overall Study
COMPLETED
|
3208
|
319
|
1168
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Myocardial Injury and Major Adverse Outcomes in Patients With COVID-19
Baseline characteristics by cohort
| Measure |
Patients Without Cardiac Injury
n=3208 Participants
If cardiac troponin was normal on first assessment and subsequently elevated with ≤50% variation, patients were considered as not having a myocardial injury
|
Patients With Chronic Myocardial Injury
n=319 Participants
Chronic myocardial injury was considered if cardiac troponin was elevated on both first and subsequent assessments with ≤20% variation
|
Patients With Acute Cardiac Injury
n=1168 Participants
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
|
Total
n=4695 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Hypertension
|
932 Participants
n=99 Participants
|
155 Participants
n=107 Participants
|
526 Participants
n=206 Participants
|
1613 Participants
n=7 Participants
|
|
Diabetes
|
590 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
339 Participants
n=206 Participants
|
1033 Participants
n=7 Participants
|
|
Chronic kidney disease
|
145 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
212 Participants
n=206 Participants
|
445 Participants
n=7 Participants
|
|
Coronary artery disease
|
251 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
266 Participants
n=206 Participants
|
600 Participants
n=7 Participants
|
|
Atrial fibrillation
|
135 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
155 Participants
n=206 Participants
|
330 Participants
n=7 Participants
|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 16.2 • n=99 Participants
|
74.1 years
STANDARD_DEVIATION 13.5 • n=107 Participants
|
72.6 years
STANDARD_DEVIATION 14.2 • n=206 Participants
|
64.7 years
STANDARD_DEVIATION 16.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
1441 Participants
n=99 Participants
|
130 Participants
n=107 Participants
|
481 Participants
n=206 Participants
|
2052 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1767 Participants
n=99 Participants
|
189 Participants
n=107 Participants
|
687 Participants
n=206 Participants
|
2643 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
675 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
307 Participants
n=206 Participants
|
1051 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
African American
|
748 Participants
n=99 Participants
|
114 Participants
n=107 Participants
|
327 Participants
n=206 Participants
|
1189 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1013 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
268 Participants
n=206 Participants
|
1361 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
160 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
224 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
470 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
172 Participants
n=206 Participants
|
687 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
142 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
183 Participants
n=7 Participants
|
|
Body Mass Index (BMI)
|
29.3 kg/m^2
STANDARD_DEVIATION 7.2 • n=99 Participants
|
27.3 kg/m^2
STANDARD_DEVIATION 6.4 • n=107 Participants
|
28.3 kg/m^2
STANDARD_DEVIATION 7.9 • n=206 Participants
|
28.9 kg/m^2
STANDARD_DEVIATION 7.3 • n=7 Participants
|
|
Smoking, active/former
|
749 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
319 Participants
n=206 Participants
|
1166 Participants
n=7 Participants
|
|
Asthma
|
171 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
226 Participants
n=7 Participants
|
|
Chronic Obstructive Pulmonary Disease (COPD)
|
91 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
174 Participants
n=7 Participants
|
|
Heart failure
|
113 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
160 Participants
n=206 Participants
|
344 Participants
n=7 Participants
|
|
Fever (T > 38.0°C)
|
610 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
194 Participants
n=206 Participants
|
853 Participants
n=7 Participants
|
|
Tachycardia (>100 beats/min)
|
1207 Participants
n=99 Participants
|
94 Participants
n=107 Participants
|
474 Participants
n=206 Participants
|
1775 Participants
n=7 Participants
|
|
Tachypnoea (≥22 breaths/min)
|
679 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
461 Participants
n=206 Participants
|
1242 Participants
n=7 Participants
|
|
Hypotension (Systolic Blood Pressure < 100 mmHg)
|
139 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
294 Participants
n=7 Participants
|
|
O2 saturation
|
91.0 percent
n=99 Participants
|
88.0 percent
n=107 Participants
|
86.0 percent
n=206 Participants
|
90.0 percent
n=7 Participants
|
|
White blood cell count
|
7.0 10^3 cells/μL
n=99 Participants
|
7.6 10^3 cells/μL
n=107 Participants
|
8.5 10^3 cells/μL
n=206 Participants
|
7.4 10^3 cells/μL
n=7 Participants
|
|
Neutrophil
|
77.4 percent of cells
n=99 Participants
|
80.0 percent of cells
n=107 Participants
|
81.4 percent of cells
n=206 Participants
|
78.6 percent of cells
n=7 Participants
|
|
Lymphocyte
|
14.3 percent of cells
n=99 Participants
|
12.9 percent of cells
n=107 Participants
|
10.2 percent of cells
n=206 Participants
|
13.3 percent of cells
n=7 Participants
|
|
Haemoglobin
|
13.3 g/dL
n=99 Participants
|
12.4 g/dL
n=107 Participants
|
12.7 g/dL
n=206 Participants
|
13.1 g/dL
n=7 Participants
|
|
Platelet
|
210.0 10^3 cells/μL
n=99 Participants
|
174.0 10^3 cells/μL
n=107 Participants
|
204.0 10^3 cells/μL
n=206 Participants
|
206.0 10^3 cells/μL
n=7 Participants
|
|
C-reactive protein
|
95.4 mg/L
n=99 Participants
|
108.3 mg/L
n=107 Participants
|
136.9 mg/L
n=206 Participants
|
106.5 mg/L
n=7 Participants
|
|
D-dimer
|
1.2 μg/mL
n=99 Participants
|
2.6 μg/mL
n=107 Participants
|
2.5 μg/mL
n=206 Participants
|
1.5 μg/mL
n=7 Participants
|
|
Ferritin
|
608.5 ng/mL
n=99 Participants
|
834.0 ng/mL
n=107 Participants
|
853.0 ng/mL
n=206 Participants
|
685.5 ng/mL
n=7 Participants
|
|
Blood urea nitrogen
|
14.0 mg/dL
n=99 Participants
|
39.0 mg/dL
n=107 Participants
|
30.0 mg/dL
n=206 Participants
|
17.0 mg/dL
n=7 Participants
|
|
Creatinine
|
0.9 mg/dL
n=99 Participants
|
1.7 mg/dL
n=107 Participants
|
1.4 mg/dL
n=206 Participants
|
1.0 mg/dL
n=7 Participants
|
PRIMARY outcome
Timeframe: 6 monthsNumber of deaths at 6 months follow up
Outcome measures
| Measure |
Patients Without Cardiac Injury
n=3208 Participants
Myocardial injury was identified by high-sensitivity cardiac troponin I levels above the 99th percentile of the upper reference limit (0.03 ng/mL) with the Abbott Architect assay.
If cardiac troponin was normal on first assessment and subsequently elevated with ≤50% variation, patients were considered as not having a myocardial injury
|
Patients With Chronic Myocardial Injury
n=319 Participants
Chronic myocardial injury was considered if cardiac troponin was elevated on both first and subsequent assessments with ≤20% variation
|
Patients With Acute Cardiac Injury
n=1168 Participants
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
|
|---|---|---|---|
|
Number of Death
|
417 Participants
|
137 Participants
|
552 Participants
|
SECONDARY outcome
Timeframe: up to 6 monthsPulmonary embolism rate as assessed by number of participants with pulmonary embolism
Outcome measures
| Measure |
Patients Without Cardiac Injury
n=3208 Participants
Myocardial injury was identified by high-sensitivity cardiac troponin I levels above the 99th percentile of the upper reference limit (0.03 ng/mL) with the Abbott Architect assay.
If cardiac troponin was normal on first assessment and subsequently elevated with ≤50% variation, patients were considered as not having a myocardial injury
|
Patients With Chronic Myocardial Injury
n=319 Participants
Chronic myocardial injury was considered if cardiac troponin was elevated on both first and subsequent assessments with ≤20% variation
|
Patients With Acute Cardiac Injury
n=1168 Participants
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
|
|---|---|---|---|
|
Number of Participants With Pulmonary Embolism
|
32 Participants
|
4 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: up to 6 monthsAcute injury rate as assessed by number of Participants with acute kidney injury
Outcome measures
| Measure |
Patients Without Cardiac Injury
n=3208 Participants
Myocardial injury was identified by high-sensitivity cardiac troponin I levels above the 99th percentile of the upper reference limit (0.03 ng/mL) with the Abbott Architect assay.
If cardiac troponin was normal on first assessment and subsequently elevated with ≤50% variation, patients were considered as not having a myocardial injury
|
Patients With Chronic Myocardial Injury
n=319 Participants
Chronic myocardial injury was considered if cardiac troponin was elevated on both first and subsequent assessments with ≤20% variation
|
Patients With Acute Cardiac Injury
n=1168 Participants
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
|
|---|---|---|---|
|
Number of Participants With Acute Kidney Injury
|
99 Participants
|
30 Participants
|
107 Participants
|
SECONDARY outcome
Timeframe: up to 6 monthsAdmission to the intensive care
Outcome measures
| Measure |
Patients Without Cardiac Injury
n=3208 Participants
Myocardial injury was identified by high-sensitivity cardiac troponin I levels above the 99th percentile of the upper reference limit (0.03 ng/mL) with the Abbott Architect assay.
If cardiac troponin was normal on first assessment and subsequently elevated with ≤50% variation, patients were considered as not having a myocardial injury
|
Patients With Chronic Myocardial Injury
n=319 Participants
Chronic myocardial injury was considered if cardiac troponin was elevated on both first and subsequent assessments with ≤20% variation
|
Patients With Acute Cardiac Injury
n=1168 Participants
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
|
|---|---|---|---|
|
Number of Admissions to the Intensive Care
|
393 admissions to ICU
|
64 admissions to ICU
|
325 admissions to ICU
|
Adverse Events
Patients Without Cardiac Injury
Serious events: 0 serious events
Other events: 0 other events
Deaths: 417 deaths
Patients With Chronic Myocardial Injury
Serious events: 0 serious events
Other events: 0 other events
Deaths: 137 deaths
Patients With Acute Cardiac Injury
Serious events: 0 serious events
Other events: 0 other events
Deaths: 552 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place