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NCT04397939

Myocardial Injury and Major Adverse Outcomes in Patients With COVID-19

Completed Results posted Last updated 8 March 2024
What this trial tests

trial in COVID-19 in 4,695 participants. Completed in 1 March 2022.

Timeline
8 May 2020
Primary endpoint
1 March 2022
1 March 2022

Quick facts

Lead sponsorIcahn School of Medicine at Mount Sinai
StatusCompleted
Study typeOBSERVATIONAL
Enrollment4,695
Start date8 May 2020
Primary completion1 March 2022
Estimated completion1 March 2022
Sites1 location across United States

Conditions studied

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

Eligibility, any sex, with COVID-19 or Myocardial Reperfusion Injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Death Primary · 6 months

Number of deaths at 6 months follow up

GroupValue95% CI
Patients Without Cardiac Injury417
Patients With Chronic Myocardial Injury137
Patients With Acute Cardiac Injury552
Number of Participants With Pulmonary Embolism Secondary · up to 6 months

Pulmonary embolism rate as assessed by number of participants with pulmonary embolism

GroupValue95% CI
Patients Without Cardiac Injury32
Patients With Chronic Myocardial Injury4
Patients With Acute Cardiac Injury22
Number of Participants With Acute Kidney Injury Secondary · up to 6 months

Acute injury rate as assessed by number of Participants with acute kidney injury

GroupValue95% CI
Patients Without Cardiac Injury99
Patients With Chronic Myocardial Injury30
Patients With Acute Cardiac Injury107
Number of Admissions to the Intensive Care Secondary · up to 6 months

Admission to the intensive care

GroupValue95% CI
Patients Without Cardiac Injury393
Patients With Chronic Myocardial Injury64
Patients With Acute Cardiac Injury325

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Cardiac involvement in the long-term implications of COVID-19.
    Satterfield BA, Bhatt DL, Gersh BJ. · · 2022 · cited 101× · PMID 34686843 · DOI 10.1038/s41569-021-00631-3

Verify or expand the search:

Other recruiting trials for COVID-19

Currently open trials in the same condition.

Other Icahn School of Medicine at Mount Sinai trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04397939.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing