Covid19NCT04756193
Evaluate Long Term Cardiovascular and Pulmonary Complications After COVID-19 With Point of Care Ultrasound
An observational study of Covid19 and Echocardiography, run by University of Louisville at 1 site in United States.
Trial summary
We hypothesize that recovered COVID-19 patients suffer long term cardiovascular and pulmonary complications, which can be detected by point of care ultrasound. The goal is to comprehensively delineate the long term cardiovascular and pulmonary ultrasound findings in recovered COVID-19 patients, identify risks factors… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Echocardiography, Ultrasound
- What is being tested?
- Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2021to 24 Sep 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Asymptomatic/Mild Group: 50 confirmed COVID-19 patients who showed no or only mild respiratory/GI symptoms; Moderate Group: 50 confirmed COVID-19 patients who were able to maintain oxygen saturation above 92% (or above 90% for patients with chronic lung disease) with up to 4 L/min oxygen via nasal prongs; Severe Group: 50 confirmed COVID-19 patients who had oxygen saturation less than 92% at rest and PaO2/FiO2 between 200 and 300; Critical Group: 50 confirmed COVID-19 patients who had PaO2/FiO2 less than 200 or required mechanical ventilation. Control Group: 50 age and sex-matched controls.
Who may be able to join
- >18 years of age
- Consent to participate in this research
- Confirmed SARS-CoV-2 infection by RT-PCR or serological tests.
Who cannot join
- Refusal to participate in this research
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville Health
Louisville, Kentucky, 40202
About this study
We hypothesize that recovered COVID-19 patients suffer long term cardiovascular and pulmonary complications, which can be detected by point of care ultrasound. The goal is to comprehensively delineate the long term cardiovascular and pulmonary ultrasound findings in recovered COVID-19 patients, identify risks factors for prolonged heart/lung injury, evaluate long term effects of applied treatment, and assess late medication/vaccine side effects in COVID-19 patients.
Read the detailed description
Aim 1: To examine the long term cardiac involvements of recovered COVID-19 patients at 3, 6, 12 months after being discharged from the hospital or symptom resolution with electrocardiogram (ECG) and echocardiography. 12 lead ECG will be obtained for all patients. Transthoracic echocardiography will be performed using GE Vivid E9 ultrasound system to measure left ventricular (LV) dimensions, LV volumes and LV ejection fraction (EF), wall thickness, LV mass, and LV remodeling index. LV diastolic function will be characterized by maximum velocities of mitral inflow E and A waves, E/A ratio, E/E' ratio (maximum myocardial velocities (E') of the lateral mitral annulus), isovolumetric relaxation time, tricuspid regurgitation velocity, and left atrial volumes. Right-ventricular function will be assessed by tricuspid annular plane systolic excursion (TAPSE), pulmonary acceleration time, and by estimation of systolic pulmonary artery pressure. We will evaluate mitral, aortic, tricuspid and pulmonic valvular stenosis and regurgitation. In addition, speckle tracking echocardiography will be used to detect subclinical impairment of myocardium in patients who have grossly normal LVEF. Lastly, inferior vena cava will be measured to assess patients' volume status.
Aim 2: To evaluate long term pulmonary involvements of recovered COVID-19 patients at 3, 6, 12 months after being discharged from the hospital or symptom resolution with pulse oximetry, bedside spirometry and lung ultrasound. Pulse oximetry, bedside spirometry, and lung ultrasonography (LUS) will be performed for all patients. The pathological LUS features for every zone will be reported as: (1) normal appearance (A lines, < 3 B lines), (2) pathologic B lines (≥3 B lines), (3) confluent B lines, (4) thickening of the pleura with pleural line irregularities (subpleural consolidation < 1 cm), (5) consolidation (≥ 1 cm), (6) pleural effusion. The LUS score, used as a correlate of loss of lung tissue aeration, as well as a normalized LUS score corrected for the number of examined zone, will be calculated in every patient.
Aim 3: To diagnose long term vascular involvements of recovered COVID-19 patients at 3, 6, 12 months after being discharged from the hospital or symptom resolution with vascular ultrasound. A trained physician or sonographer will use high resolution gray-scale imaging, color Doppler ultrasound and spectral analysis with pulse wave Doppler to examine bilateral upper/lower extremity venous and arterial systems and carotid arteries for thrombosis, atheroma, and stenosis.
- Conditions
- Covid19, Echocardiography, Ultrasound
- Being tested
- Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasoundDiagnostic test
Also called ECG, pulse oximetry, blood draw, spirometry
Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound, ECG, pulse oximetry, blood draw, spirometry
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic/Mild COVID-19 Group | 50 confirmed COVID-19 patients who showed no or only mild respiratory/GI symptoms (not admitted to the hospital at all) Receives: Diagnostic Test: Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound | |
| Moderate COVID-19 Group | 50 confirmed COVID-19 patients who were able to maintain oxygen saturation above 92% (or above 90% for patients with chronic lung disease) with up to 4 L/min oxygen via nasal prongs (admitted to the hospital, but never to the ICU and no obvious cardiac complications during the stay) Receives: Diagnostic Test: Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound | |
| Severe COVID-19 Group | 50 confirmed COVID-19 patients who had oxygen saturation lower than 92% at rest and PaO2/FiO2 between 200 and 300 (High-flow oxygen group, mostly in the ICU, and may have some cardiac complications) Receives: Diagnostic Test: Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound | |
| Critical COVID-19 Group | 50 confirmed COVID-19 patients who had PaO2/FiO2 less than 200 or required mechanical ventilation (in the ICU, need mechanical ventilation and more likely to have cardiac complications) Receives: Diagnostic Test: Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound | |
| Control Group | 50 age and sex-matched controls from our hospital admission database Receives: Diagnostic Test: Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic strain measurements of the left, right heart
strain is a measurement of systolic function of the heart, unit is %. The more negative means better outcome
Measured: Up to 12 months
Secondary outcomes (1)
Lung ultrasound measurements
lung ultrasound scores, B line numbers
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start15 Apr 2021
- Primary completion24 Sep 2024
- Study completion24 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Jiapeng Huang, University of Louisville
- Investigators
- Jiapeng Huang, MD, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756193
- Sponsor's protocol ID
- 20.0836
- Status last verified
- Oct 2024
- First submitted
- 7 Feb 2021
- Last updated
- 30 Oct 2024
- 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 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate Long Term Cardiovascular and Pulmonary Complications After COVID-19 With Point of Care Ultrasound
- ClinicalTrials.gov ID
- NCT04756193
- Acronym / sponsor ID
- 20.0836
- Conditions
- Covid19, Echocardiography, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 16 Feb 2021 (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.
We hypothesize that recovered COVID-19 patients suffer long term cardiovascular and pulmonary complications, which can be detected by point of care ultrasound. The goal is to comprehensively delineate the long term cardiovascular and pulmonary ultrasound findings in recovered COVID-19 patients, identify risks factors for prolonged heart/lung injury, evaluate long term effects of applied treatment, and assess late medication/vaccine side effects in COVID-19 patients.
Detailed description
Aim 1: To examine the long term cardiac involvements of recovered COVID-19 patients at 3, 6, 12 months after being discharged from the hospital or symptom resolution with electrocardiogram (ECG) and echocardiography. 12 lead ECG will be obtained for all patients. Transthoracic echocardiography will be performed using GE Vivid E9 ultrasound system to measure left ventricular (LV) dimensions, LV volumes and LV ejection fraction (EF), wall thickness, LV mass, and LV remodeling index. LV diastolic function will be characterized by maximum velocities of mitral inflow E and A waves, E/A ratio, E/E' ratio (maximum myocardial velocities (E') of the lateral mitral annulus), isovolumetric relaxation time, tricuspid regurgitation velocity, and left atrial volumes. Right-ventricular function will be assessed by tricuspid annular plane systolic excursion (TAPSE), pulmonary acceleration time, and by estimation of systolic pulmonary artery pressure. We will evaluate mitral, aortic, tricuspid and pulmonic valvular stenosis and regurgitation. In addition, speckle tracking echocardiography will be used to detect subclinical impairment of myocardium in patients who have grossly normal LVEF. Lastly, inferior vena cava will be measured to assess patients' volume status.
Aim 2: To evaluate long term pulmonary involvements of recovered COVID-19 patients at 3, 6, 12 months after being discharged from the hospital or symptom resolution with pulse oximetry, bedside spirometry and lung ultrasound. Pulse oximetry, bedside spirometry, and lung ultrasonography (LUS) will be performed for all patients. The pathological LUS features for every zone will be reported as: (1) normal appearance (A lines, < 3 B lines), (2) pathologic B lines (≥3 B lines), (3) confluent B lines, (4) thickening of the pleura with pleural line irregularities (subpleural consolidation < 1 cm), (5) consolidation (≥ 1 cm), (6) pleural effusion. The LUS score, used as a correlate of loss of lung tissue aeration, as well as a normalized LUS score corrected for the number of examined zone, will be calculated in every patient.
Aim 3: To diagnose long term vascular involvements of recovered COVID-19 patients at 3, 6, 12 months after being discharged from the hospital or symptom resolution with vascular ultrasound. A trained physician or sonographer will use high resolution gray-scale imaging, color Doppler ultrasound and spectral analysis with pulse wave Doppler to examine bilateral upper/lower extremity venous and arterial systems and carotid arteries for thrombosis, atheroma, and stenosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic/Mild COVID-19 Group | – | Diagnostic Test: Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound50 confirmed COVID-19 patients who showed no or only mild respiratory/GI symptoms (not admitted to the hospital at all) |
| Moderate COVID-19 Group | – | Diagnostic Test: Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound50 confirmed COVID-19 patients who were able to maintain oxygen saturation above 92% (or above 90% for patients with chronic lung disease) with up to 4 L/min oxygen via nasal prongs (admitted to the hospital, but never to the ICU and no obvious cardiac complications during the stay) |
| Severe COVID-19 Group | – | Diagnostic Test: Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound50 confirmed COVID-19 patients who had oxygen saturation lower than 92% at rest and PaO2/FiO2 between 200 and 300 (High-flow oxygen group, mostly in the ICU, and may have some cardiac complications) |
| Critical COVID-19 Group | – | Diagnostic Test: Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound50 confirmed COVID-19 patients who had PaO2/FiO2 less than 200 or required mechanical ventilation (in the ICU, need mechanical ventilation and more likely to have cardiac complications) |
| Control Group | – | Diagnostic Test: Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound50 age and sex-matched controls from our hospital admission database |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Asymptomatic/Mild Group: 50 confirmed COVID-19 patients who showed no or only mild respiratory/GI symptoms; Moderate Group: 50 confirmed COVID-19 patients who were able to maintain oxygen saturation above 92% (or above 90% for patients with chronic lung disease) with up to 4 L/min oxygen via nasal prongs; Severe Group: 50 confirmed COVID-19 patients who had oxygen saturation less than 92% at rest and PaO2/FiO2 between 200 and 300; Critical Group: 50 confirmed COVID-19 patients who had PaO2/FiO2 less than 200 or required mechanical ventilation. Control Group: 50 age and sex-matched controls.
Key inclusion criteria (3 listed)
- >18 years of age
- Consent to participate in this research
- Confirmed SARS-CoV-2 infection by RT-PCR or serological tests.
Key exclusion criteria (1 listed)
- Refusal to participate in this research
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 |
|---|---|---|
| Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasoundAlso: ECG, pulse oximetry, blood draw, spirometryPoint of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound, ECG, pulse oximetry, blood draw, spirometry | Diagnostic test | Asymptomatic/Mild COVID-19 Group, Control Group, Critical COVID-19 Group, Moderate COVID-19 Group, Severe COVID-19 Group |
Primary outcome
Echocardiographic strain measurements of the left, right heart
Time frame: Up to 12 months
strain is a measurement of systolic function of the heart, unit is %. The more negative means better outcome
1 secondary outcome
Lung ultrasound measurements
Time frame: Up to 12 months
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 30 Oct 2024.
- 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.
Jiapeng Huang, MD, PhD principal investigator
University of Louisville
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 Echocardiography, run by University of Louisville 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 3 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 30 Oct 2024. 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?
Echocardiographic strain measurements of the left, right heart (time frame: Up to 12 months). 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 30 Oct 2024.