Myocardial Damage in COVID-19

March 13, 2020 updated by: Xiang Cheng, Wuhan Union Hospital, China

Retrospective Study of Myocardial Damage in COVID-19

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The laboratory-confirmed patients with confirmed COVID-19 admitted to headquarters, west campus and cancer center of Union Hospital, Tongji Medical College, Huazhong University of science and technology, from January 1st to March 15th, 2020

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Discharged group
The individual which is defined as patient discharged from hospital
Other: non
no intervention
Dead group
The individual which is defined as patient with all-cause death
Other: non
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The myocardial injury incidence
Time Frame: 75 days
The myocardial injury incidence of COVID-19 patients
75 days
The risk factors analysis for the death
Time Frame: 75 days
The risk factors analysis for the death of COVID-19 patients
75 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical characteristics
Time Frame: 75 days
The clinical characteristics description of COVID-19 patients
75 days
Clinical course
Time Frame: 75 days
The clinical course description of COVID-19 patients
75 days
Cardiovascular comorbidity
Time Frame: 75 days
The clinical characteristics and prognosis analysis in different cardiovascular comorbidity of COVID-19 patients
75 days
Analysis of causes of death
Time Frame: 75 days
Analysis of causes of death in COVID-19 patients
75 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

March 15, 2020

Study Completion (Anticipated)

March 18, 2020

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 13, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 13, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-COVID-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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