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Cardiovascular Risk Stratification in Covid-19 (CaVaR-Co19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04555187
Recruitment Status : Active, not recruiting
First Posted : September 18, 2020
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Larisa Tereshchenko, Oregon Health and Science University

Study Description
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Brief 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

Condition or disease
Covid19 Cardiovascular Risk Factor

Study Design
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Study Type : Observational
Estimated Enrollment : 60000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cardiovascular Risk Stratification in Covid-19
Actual Study Start Date : June 8, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Covid19-positive
Covid19 test positive. age >= 18 y.
Covid19-negative
Covid19 test negative. age >=18y


Outcome Measures
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Primary Outcome Measures :
  1. Number and rate of persons with cardiovascular composite outcome [ Time Frame: 6 months after Covid19 test ]
    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.


Secondary Outcome Measures :
  1. Rate of all-cause death outcome [ Time Frame: 6 months after covid19 test ]
    Rate of all-cause death outcome

  2. Rate of cardiac arrhythmia [ Time Frame: 6 months after covid19 test ]
    Rate of any documented cardiac arrhythmia (tachy - or brady- arrhythmia)


Eligibility Criteria
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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
Records of patients who had Covid19 test performed
Criteria

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
Contacts and Locations
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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): NCT04555187


Locations
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United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Larisa G Tereshchenko, MD, PhD Oregon Health and Science University
More Information
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Responsible Party: Larisa Tereshchenko, Associate Professor of Medicine, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT04555187    
Other Study ID Numbers: STUDY00021368
First Posted: September 18, 2020    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Larisa Tereshchenko, Oregon Health and Science University:
Covid19
cardiovascular risk factor
electrocardiogram
risk stratification
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases