Cardiovascular Risk Stratification in Covid-19

Covid19 Clinical Trial

— CaVaR-Co19  

Official title:

Cardiovascular Risk Stratification in Covid-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04555187
• Other study ID #: STUDY00021368
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• COVID-19
• Covid19

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