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NCT04312464 Clinical Trial

Myocardial Damage in COVID-19

COVID-19 Clinical Trial

Official title:
Retrospective Study of Myocardial Damage in COVID-19

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04312464
Other study ID # MD-COVID-19
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date March 18, 2020

Study information
Verified date March 2020
Source Wuhan Union Hospital, China
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to investigate the clinical characteristics, the incidence of myocardial injury, and the influence of myocardial injury on the prognosis in COVID-19 patients. There is no additional examination and treatment for this project.

Description:

The epidemic of the COVID-19 has expanded from Wuhan through out China, and is being exported to a growing number of countries. Recently, investigators have revealed that acute myocardial injury is existed in 7.2% patients with COVID-19, and this proportion in patients admitted to the ICU (22.2%) is higher than patients not treated in the ICU (2.0%). Thus, cardiac troponin I (cTNI), the biomarker of cardiac injury, might be a clinical predictor of COVID-19 patient outcomes. This study aims to investigate the clinical characteristics, the incidence of myocardial injury, and the influence of myocardial injury on the prognosis in COVID-19 patients.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 500
Est. completion date March 18, 2020
Est. primary completion date March 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- (1) Age =18 years. (2) Laboratory (RT-PCR) confirmed infection with SARS-CoV-2. (3) Lung involvement confirmed with chest imaging.

Exclusion Criteria:

- No cTnI test on admission

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• non
no intervention

Locations
Country Name City State
China Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei

Sponsors (1)
Lead Sponsor Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The myocardial injury incidence The myocardial injury incidence of COVID-19 patients 75 days
Primary The risk factors analysis for the death The risk factors analysis for the death of COVID-19 patients 75 days
Secondary Clinical characteristics The clinical characteristics description of COVID-19 patients 75 days
Secondary Clinical course The clinical course description of COVID-19 patients 75 days
Secondary Cardiovascular comorbidity The clinical characteristics and prognosis analysis in different cardiovascular comorbidity of COVID-19 patients 75 days
Secondary Analysis of causes of death Analysis of causes of death in COVID-19 patients 75 days
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