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Myocardial Damage in COVID-19

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ClinicalTrials.gov Identifier: NCT04312464
Recruitment Status : Enrolling by invitation
First Posted : March 18, 2020
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Xiang Cheng, Wuhan Union Hospital, China

Brief 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.

Condition or disease Intervention/treatment
COVID-19 Cardiovascular Diseases Other: non

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Retrospective Study of Myocardial Damage in COVID-19
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : March 18, 2020

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




Primary Outcome Measures :
  1. The myocardial injury incidence [ Time Frame: 75 days ]
    The myocardial injury incidence of COVID-19 patients

  2. The risk factors analysis for the death [ Time Frame: 75 days ]
    The risk factors analysis for the death of COVID-19 patients


Secondary Outcome Measures :
  1. Clinical characteristics [ Time Frame: 75 days ]
    The clinical characteristics description of COVID-19 patients

  2. Clinical course [ Time Frame: 75 days ]
    The clinical course description of COVID-19 patients

  3. Cardiovascular comorbidity [ Time Frame: 75 days ]
    The clinical characteristics and prognosis analysis in different cardiovascular comorbidity of COVID-19 patients

  4. Analysis of causes of death [ Time Frame: 75 days ]
    Analysis of causes of death in COVID-19 patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

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): NCT04312464


Locations
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China, Hubei
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Sponsors and Collaborators
Wuhan Union Hospital, China
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Responsible Party: Xiang Cheng, Professor, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT04312464    
Other Study ID Numbers: MD-COVID-19
First Posted: March 18, 2020    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiang Cheng, Wuhan Union Hospital, China:
COVID-19
myocardial injury
Additional relevant MeSH terms:
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Cardiovascular Diseases