Evaluate Long Term Cardiovascular and Pulmonary Complications After COVID-19 With Point of Care Ultrasound

February 13, 2024 updated by: Jiapeng Huang, University of Louisville
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.

Study Overview

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 Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville Health
        • Contact:
        • Principal Investigator:
          • Jiapeng Huang, Md, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • >18 years of age
  • Consent to participate in this research
  • Confirmed SARS-CoV-2 infection by RT-PCR or serological tests.

Exclusion Criteria:

  • Refusal to participate in this research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound, ECG, pulse oximetry, blood draw, spirometry
Other Names:
  • ECG, pulse oximetry, blood draw, spirometry
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)
Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound, ECG, pulse oximetry, blood draw, spirometry
Other Names:
  • ECG, pulse oximetry, blood draw, spirometry
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)
Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound, ECG, pulse oximetry, blood draw, spirometry
Other Names:
  • ECG, pulse oximetry, blood draw, spirometry
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)
Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound, ECG, pulse oximetry, blood draw, spirometry
Other Names:
  • ECG, pulse oximetry, blood draw, spirometry
Control Group
50 age and sex-matched controls from our hospital admission database
Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound, ECG, pulse oximetry, blood draw, spirometry
Other Names:
  • ECG, pulse oximetry, blood draw, spirometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung ultrasound measurements
Time Frame: Up to 12 months
lung ultrasound scores, B line numbers
Up to 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vascular ultrasound findings
Time Frame: Up to 12 months
High resolution gray-scale imaging, color Doppler ultrasound and spectral analysis (cm/s) with pulse wave Doppler to examine bilateral upper/lower extremity venous and arterial systems and carotid arteries for thrombosis, atheroma, and stenosis.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Jiapeng Huang, MD, PhD, University of Louisville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

February 7, 2021

First Submitted That Met QC Criteria

February 13, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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