Myocardial Injury and Major Adverse Outcomes in Patients With COVID-19
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| ClinicalTrials.gov Identifier: NCT04397939 |
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Recruitment Status :
Completed
First Posted : May 21, 2020
Last Update Posted : April 19, 2022
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| Condition or disease |
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| COVID-19 Myocardial Reperfusion Injury Cardiovascular Diseases |
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.
| Study Type : | Observational |
| Actual Enrollment : | 4695 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Association of Early Myocardial Injury With Major Adverse Outcomes in Patients With COVID-19 |
| Actual Study Start Date : | May 8, 2020 |
| Actual Primary Completion Date : | March 1, 2022 |
| Actual Study Completion Date : | March 1, 2022 |
| Group/Cohort |
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Patients with Cardiac Injury
Patients with cardiac injury
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Patients without cardiac injury
Patients without cardiac injury
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- Number of Death [ Time Frame: up to 6 months ]Number of death
- Number of participants with pulmonary embolism [ Time Frame: up to 6 months ]Pulmonary embolism rate as assessed by number of participants with pulmonary embolism
- Number of Participants with acute kidney injury [ Time Frame: up to 6 months ]Acute injury rate as assessed by number of Participants with acute kidney injury
- Number of admissions to the intensive care [ Time Frame: up to 6 months ]Admission to the intensive care
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Laboratory confirmed COVID-19
Exclusion Criteria:
- None
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397939
| United States, New York | |
| Mount Sinai Hospital | |
| New York, New York, United States, 10029 | |
| Principal Investigator: | Annapoorna Kini, MD | Icahn School of Medicine at Mount Sinai |
| Responsible Party: | Annapoorna Kini, Director, Catheterization Laboratory, Icahn School of Medicine at Mount Sinai |
| ClinicalTrials.gov Identifier: | NCT04397939 |
| Other Study ID Numbers: |
GCO 20-0965 |
| First Posted: | May 21, 2020 Key Record Dates |
| Last Update Posted: | April 19, 2022 |
| Last Verified: | April 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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COVID-19 Myocardial Injury Cardiovascular Disease Cardiac Troponin |
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COVID-19 Cardiovascular Diseases Reperfusion Injury Myocardial Reperfusion Injury Wounds and Injuries Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections |
Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Vascular Diseases Postoperative Complications Pathologic Processes Cardiomyopathies Heart Diseases Myocardial Ischemia |