Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04756193
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2021-02-07
Brief Title:
Evaluate Long Term Cardiovascular and Pulmonary Complications After COVID-19 With Point of Care Ultrasound
Sponsor:
University of Louisville
Organization:
University of Louisville
Study Overview
Official Title:
Evaluate Long Term Cardiovascular and Pulmonary Complications After COVID-19 With Point of Care Ultrasound
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 heartlung injury evaluate long term effects of applied treatment and assess late medicationvaccine 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 EA ratio EE 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 upperlower extremity venous and arterial systems and carotid arteries for thrombosis atheroma and stenosis
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 upperlower extremity venous and arterial systems and carotid arteries for thrombosis atheroma and stenosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None