Covid19CaVaR-Co19NCT04555187
Cardiovascular Risk Stratification in Covid-19
An observational study of Covid19 and Cardiovascular Risk Factor, run by Oregon Health and Science University at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Covid19, Cardiovascular Risk Factor
- How many people
- 1,355 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2020to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Records of patients who had Covid19 test performed
Who may be able to join
- age >=18y
- available data on Covid19 test in the electronic medical record (either positive or negative)
Who cannot join
- no data of Covid19 test
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
This retrospective double-cohort study seeks to:
- Describe the cardiovascular manifestations and electrophysiological (EP) substrate in COVID-19 infection and their association with clinical outcomes; and
- Develop a method of cardiovascular risk stratification in COVID-19
- Conditions
- Covid19, Cardiovascular Risk Factor
- Keywords
- Covid19, cardiovascular risk factor, electrocardiogram, risk stratification
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Covid19-positive | Covid19 test positive. age >= 18 y. | |
| Covid19-negative | Covid19 test negative. age >=18y |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after Covid19 test
Secondary outcomes (2)
Rate of all-cause death outcome
Rate of all-cause death outcome
Measured: 6 months after covid19 test
Rate of cardiac arrhythmia
Rate of any documented cardiac arrhythmia (tachy - or brady- arrhythmia)
Measured: 6 months after covid19 test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start8 Jun 2020
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larisa Tereshchenko, Oregon Health and Science University
- Investigators
- Larisa G Tereshchenko, MD, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555187
- Sponsor's protocol ID
- STUDY00021368
- Acronym
- CaVaR-Co19
- Status last verified
- Nov 2023
- First submitted
- 16 Sep 2020
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35843735Tereshchenko 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.
PubMed 36963283
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Stratification in Covid-19
- ClinicalTrials.gov ID
- NCT04555187
- Acronym / sponsor ID
- CaVaR-Co19 / STUDY00021368
- Conditions
- Covid19, Cardiovascular Risk Factor
- Keywords
- Covid19, cardiovascular risk factor, electrocardiogram, risk stratification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,355 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective double-cohort study seeks to:
- Describe the cardiovascular manifestations and electrophysiological (EP) substrate in COVID-19 infection and their association with clinical outcomes; and
- Develop a method of cardiovascular risk stratification in COVID-19
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid19-positive | – | –Covid19 test positive. age >= 18 y. |
| Covid19-negative | – | –Covid19 test negative. age >=18y |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Records of patients who had Covid19 test performed
Key inclusion criteria (2 listed)
- age >=18y
- available data on Covid19 test in the electronic medical record (either positive or negative)
Key exclusion criteria (1 listed)
- no data of Covid19 test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Rate of all-cause death outcome
Time frame: 6 months after covid19 test
Rate of cardiac arrhythmia
Time frame: 6 months after covid19 test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Results publication: PubMed 35843735Tereshchenko 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.
- Derived from this study: PubMed 36963283Tereshchenko 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larisa G Tereshchenko, MD, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Cardiovascular Risk Factor, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and rate of persons with cardiovascular composite outcome (time frame: 6 months after Covid19 test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04555187, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.