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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04555187
Other study ID # STUDY00021368
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 8, 2020
Est. completion date December 1, 2021

Study information

Verified date November 2023
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This retrospective double-cohort study seeks to: 1. Describe the cardiovascular manifestations and electrophysiological (EP) substrate in COVID-19 infection and their association with clinical outcomes; and 2. Develop a method of cardiovascular risk stratification in COVID-19


Recruitment information / eligibility

Status Completed
Enrollment 1355
Est. completion date December 1, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria: - age >=18y - available data on Covid19 test in the electronic medical record (either positive or negative) Exclusion Criteria: - no data of Covid19 test

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Oregon Health and Science University Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tereshchenko LG, Bishop A, Fisher-Campbell N, Levene J, Morris CC, Patel H, Beeson E, Blank JA, Bradner JN, Coblens M, Corpron JW, Davison JM, Denny K, Earp MS, Florea S, Freeman H, Fuson O, Guillot FH, Haq KT, Kim M, Kolseth C, Krol O, Lin L, Litwin L, M — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number and rate of persons with cardiovascular composite outcome Number and rate of persons with composite of all-cause death, critical care utilization (ICU bed), development of a life-threatening arrhythmia (ventricular tachycardia/ventricular fibrillation or sudden cardiac arrest), acute heart failure, myocardial infarction (STEMI, NSTEMI, or silent MI), or incident stroke, whichever comes first. 6 months after Covid19 test
Secondary Rate of all-cause death outcome Rate of all-cause death outcome 6 months after covid19 test
Secondary Rate of cardiac arrhythmia Rate of any documented cardiac arrhythmia (tachy - or brady- arrhythmia) 6 months after covid19 test
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