Myocardial Injury and Major Adverse Outcomes in Patients With COVID-19
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04397939|
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : June 16, 2020
|Condition or disease|
|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 As of April 6, 2020, there have been 1,917 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 April 2020 with laboratory-confirmed COVID-19 will be included in the retrospective study.
|Study Type :||Observational|
|Estimated Enrollment :||5000 participants|
|Official Title:||Association of Early Myocardial Injury With Major Adverse Outcomes in Patients With COVID-19|
|Actual Study Start Date :||May 8, 2020|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2022|
Patients with Cardiac Injury
Patients with cardiac injury
Patients without cardiac injury
Patients without cardiac injury
- Number of In-Hospital Death [ Time Frame: During hospitalization, average 2-3 weeks ]Number of death during hospitalization
- Length of Stay [ Time Frame: During hospitalization, average 2-3 weeks ]Length of stay in the hospital
- Number of Successful Treatment [ Time Frame: During hospitalization, average 2-3 weeks ]Successful treatment will be defined by two consecutive negative tests for COVID-19
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
|Contact: Yuliya Vengrenyuk, PhDfirstname.lastname@example.org|
|United States, New York|
|Mount Sinai Hospital||Recruiting|
|New York, New York, United States, 10029|
|Contact: Yuliya Vengrenyuk, PhD 212-241-0460 email@example.com|
|Principal Investigator: Annapoorna Kini, MD|
|Principal Investigator:||Annapoorna Kini, MD||Icahn School of Medicine at Mount Sinai|