COVIDCOVASNCT04468412
Influence of COVID-19 on Vascular Endothelial Function
An observational study of COVID and Vascular; Damage, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Infection with severe acute respiratory syndrome coronavirus (SARS-CoV) 2 could result in endothelial dysfunction with increased risk of arterial thrombotic events by downregulating the expression of angiotensin converting enzyme 2 (ACE2). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- COVID, Vascular; Damage
- What is being tested?
- Carotid Artery Reactivity Testing
- How many people
- 203 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Jul 2020to 30 Mar 2022
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with past COVID-19 infection will be recruited at Bernhoven hospital, the Netherlands.
Who may be able to join
- Confirmed SARS-CoV2 infection by polymerase chain reaction on nasopharyngeal swab, sputum or bronchoalveolar lavage.
- At least 6 and no more than 20 weeks after resolution of COVID-19 related symptoms
- ≥ 16 years old
Who cannot join
- Recent (<3 months) angina pectoris, myocardial infarction, stroke, or heart failure
- Raynaud syndrome, scleroderma, complex regional pain syndrome of the upper extremity or presence of arteriovenous fistula or open wounds on both the upper extremities.
Trial locations and contacts
1 site in 1 country.
About this study
Rationale: Infection with severe acute respiratory syndrome coronavirus (SARS-CoV) 2 could result in endothelial dysfunction with increased risk of arterial thrombotic events by downregulating the expression of angiotensin converting enzyme 2 (ACE2). Endothelial function can be easily and non-invasively determined by carotid artery reactivity (CAR) testing.
Objective: To investigate the predictive value of endothelial dysfunction, measured by carotid artery reactivity testing, for 1-year cardiovascular events in patients with past COVID-19 infection.
Read more
Study design: A prospective observational longitudinal cohort study.
Study population: Patients recovered from confirmed infection with SARS-CoV2.
Main study parameters/endpoints: macrovascular endothelial function measured by carotid artery reactivity testing.
- Conditions
- COVID, Vascular; Damage
- Being tested
- Carotid Artery Reactivity Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Artery Reactivity TestingDiagnostic test
Also called Cold pressor test
The carotid artery reactivity (CAR) test assesses macrovascular endothelial function by measuring the carotid artery diameter in response to sympathetic stimulation. Participants are in the supine position with the neck extended for assessment of the carotid artery. Left carotid artery diameter is recorded continuously during baseline (30 seconds) and during immersion of the right hand up to the wrist in icy water (4°C) for 3 minutes. CAR can either represent a dilatory response (normal endothelial function) or a constrictive response (endothelial dysfunction) of the carotid artery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial dysfunction
Change in endothelial dysfunction as determined by CAR test.
Measured: CAR will be measures between 6 and 20 weeks and 1 year after recovery from COVID-19.
Secondary outcomes (1)
Major adverse cardiovascular events (MACE)
MACE include non-fatal myocardial infarction, non-fatal ischemic stroke, acute limb ischemia, need for revascularization, amputation and cardiovascular death.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start14 Jul 2020
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- Prospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bernhoven Hospital
- Responsible party
- Sponsor
- Investigators
- Michiel C Warle, PhD, Principal investigator, Radboud University Medical CenterAndre S van Petersen, PhD, Principal investigator, Benhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468412
- Sponsor's protocol ID
- NL2020-6555
- Acronym
- COVAS
- Status last verified
- Sep 2021
- First submitted
- 9 Jul 2020
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of COVID-19 on Vascular Endothelial Function
- ClinicalTrials.gov ID
- NCT04468412
- Acronym / sponsor ID
- COVAS / NL2020-6555
- Conditions
- COVID, Vascular; Damage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Bernhoven Hospital
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 13 Jul 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.
Rationale: Infection with severe acute respiratory syndrome coronavirus (SARS-CoV) 2 could result in endothelial dysfunction with increased risk of arterial thrombotic events by downregulating the expression of angiotensin converting enzyme 2 (ACE2). Endothelial function can be easily and non-invasively determined by carotid artery reactivity (CAR) testing.
Objective: To investigate the predictive value of endothelial dysfunction, measured by carotid artery reactivity testing, for 1-year cardiovascular events in patients with past COVID-19 infection.
Study design: A prospective observational longitudinal cohort study.
Study population: Patients recovered from confirmed infection with SARS-CoV2.
Main study parameters/endpoints: macrovascular endothelial function measured by carotid artery reactivity testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with past COVID-19 infection will be recruited at Bernhoven hospital, the Netherlands.
Key inclusion criteria (3 listed)
- Confirmed SARS-CoV2 infection by polymerase chain reaction on nasopharyngeal swab, sputum or bronchoalveolar lavage.
- At least 6 and no more than 20 weeks after resolution of COVID-19 related symptoms
- ≥ 16 years old
Key exclusion criteria (2 listed)
- Recent (<3 months) angina pectoris, myocardial infarction, stroke, or heart failure
- Raynaud syndrome, scleroderma, complex regional pain syndrome of the upper extremity or presence of arteriovenous fistula or open wounds on both the upper extremities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid Artery Reactivity TestingAlso: Cold pressor testThe carotid artery reactivity (CAR) test assesses macrovascular endothelial function by measuring the carotid artery diameter in response to sympathetic stimulation. Participants are in the supine position with the neck extended for assessment of the carotid artery. Left carotid artery diameter is recorded continuously during baseline (30 seconds) and during immersion of the right hand up to the wrist in icy water (4°C) for 3 minutes. CAR can either represent a dilatory response (normal endothelial function) or a constrictive response (endothelial dysfunction) of the carotid artery. | Diagnostic test | – |
Primary outcome
Endothelial dysfunction
Time frame: CAR will be measures between 6 and 20 weeks and 1 year after recovery from COVID-19.
Change in endothelial dysfunction as determined by CAR test.
1 secondary outcome
Major adverse cardiovascular events (MACE)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Michiel C Warle, PhD principal investigator
Radboud University Medical Center
Andre S van Petersen, PhD principal investigator
Benhoven
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 COVID and Vascular; Damage, run by Radboud University Medical Center at 1 site in Netherlands.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Jan 2022. 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 Netherlands. 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?
Results are not available in the source record.
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?
Endothelial dysfunction (time frame: CAR will be measures between 6 and 20 weeks and 1 year after recovery from COVID-19.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2022.