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Clinical Trials/NCT04756193
NCT04756193
Completed
Not Applicable

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

University of Louisville1 site in 1 country98 target enrollmentApril 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
University of Louisville
Enrollment
98
Locations
1
Primary Endpoint
Echocardiographic strain measurements of the left, right heart
Status
Completed
Last Updated
last year

Overview

Brief 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 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.

Registry
clinicaltrials.gov
Start Date
April 15, 2021
End Date
September 24, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jiapeng Huang

Professor, MD, PhD

University of Louisville

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Lung ultrasound measurements(Up to 12 months)

Study Sites (1)

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