Clincosm LogoSign in Get a demo

CaVaR-Co19: Cardiovascular Risk Stratification in Covid-19

Sponsor
Oregon Health and Science University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04555187
Collaborator
(none)
60,000
Enrollment
1
Location
29.8
Anticipated Duration (Months)
2015.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Cardiovascular Risk Stratification in Covid-19
    Actual Study Start Date :
    Jun 8, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Covid19-positive

    Covid19 test positive. age >= 18 y.
    Covid19-negative

    Covid19 test negative. age >=18y

    Outcome Measures

    Primary Outcome Measures

    1. Number and rate of persons with cardiovascular composite outcome [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 [6 months after covid19 test]

      Rate of all-cause death outcome

    2. Rate of cardiac arrhythmia [6 months after covid19 test]

      Rate of any documented cardiac arrhythmia (tachy - or brady- arrhythmia)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Oregon Health and Science University Portland Oregon United States 97239

    Sponsors and Collaborators

    • Oregon Health and Science University

    Investigators

    • Principal Investigator: Larisa G Tereshchenko, MD, PhD, Oregon Health and Science University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Larisa Tereshchenko, Associate Professor of Medicine, Oregon Health and Science University
    ClinicalTrials.gov Identifier:
    NCT04555187
    Other Study ID Numbers:
    • STUDY00021368
    First Posted:
    Sep 18, 2020
    Last Update Posted:
    May 25, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Larisa Tereshchenko, Associate Professor of Medicine, Oregon Health and Science University
    Covid19
    cardiovascular risk factor
    electrocardiogram
    risk stratification
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of May 25, 2021