Cardiovascular Risk Stratification in Covid-19

NCT04555187 | Completed

• 1 other identifier: STUDY00021368
• Study Type: observational
• Target: 1,355
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective double-cohort study seeks to:

1. 1.Describe the cardiovascular manifestations and electrophysiological (EP) substrate in COVID-19 infection and their association with clinical outcomes; and
2. 2.Develop a method of cardiovascular risk stratification in COVID-19

Conditions

Covid19; Cardiovascular Risk Factor

Keywords

Covid19; cardiovascular risk factor; electrocardiogram; risk stratification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rate of all-cause death outcome

  6 months after covid19 test

• Rate of cardiac arrhythmia

  6 months after covid19 test

Study Arms (2)

Covid19-positive

Covid19 test positive. age \>= 18 y.

Covid19-negative

Covid19 test negative. age \>=18y

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Records of patients who had Covid19 test performed

You may qualify if:

• age \>=18y
• available data on Covid19 test in the electronic medical record (either positive or negative)

You may not qualify if:

• no data of Covid19 test

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (2)

• 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, Malik A, Mitchell E, Mohapatra A, Mullen C, Nix CD, Oyeyemi A, Rutlen C, Tam AE, Van Buren I, Wallace J, Khan A. Risk of Cardiovascular Events After COVID-19. Am J Cardiol. 2022 Sep 15;179:102-109. doi: 10.1016/j.amjcard.2022.06.023. Epub 2022 Jul 15.

  PMID: 35843735 RESULT

• Tereshchenko LG, Pourbemany J, Haq KT, Patel H, Hyde J, Quadri S, Ibrahim H, Tongpoon A, Pourbemany R, Khan A. An electrophysiological substrate of COVID-19. J Electrocardiol. 2023 Jul-Aug;79:61-65. doi: 10.1016/j.jelectrocard.2023.03.010. Epub 2023 Mar 20.

  PMID: 36963283 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Larisa G Tereshchenko, MD, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 18, 2020
• Study Start: June 8, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

US (1)