Left Atrial Function of COVID-19-recovered Patients During the Surge of Omicron Variants

Assessment of Left Atrial Function of COVID-19-recovered Patients During the Surge of Omicron Variants by Two-dimensional Speckle Tracking Echocardiography

The goal of this observational study is to retrospectively analyze left atrial function in mild to moderate COVID-19-recovered patients. The main questions it aims to answer are:

• Whether left atrial function is involved in patients with mild to moderate COVID-19 after recovery.
• What are the factors that may be associated with persistent heart-related symptoms (including chest pain, chest tightness, palpitations, shortness of breath, or postural tachycardia) in patients with mild to moderate COVID-19 ?

Participants will undergo transthoracic echocardiography to obtain conventional ultrasound parameters, two-dimensional strain parameters will been obtained through software post-processing, and general clinical data and laboratory test results will been obtained.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19 Pandemic
• Intervention / Treatment: Diagnostic test: two-dimensional speckle tracking echocardiography

Detailed Description

The included patients who recovered from COVID-19 infection and healthy people underwent transthoracic echocardiography at the First Affiliated Hospital of Shandong First Medical University from December 20, 2022 to January 20, 2023. Routine data and two-dimensional strain parameters of transthoracic echocardiography of the study subjects were obtained:

1. The echocardiographic examination was performed using a Epiq 7C ultrasound machine, and images were acquired with the patient in left lateral decubitus using a 3.5-5 MHz transducer at a depth of 16 cm. ECG was recorded, and 3 consecutive cardiac cycles of each view were recorded during quiet breathing at 50-80 frames/sec. All patients were subjected to conventional transthoracic echocardiography & Speckle tracking echocardiography (STE). All measurements were taken following the American Society of Echocardiography (ASE) recommendations.
2. Left atrial strain analysis was obtained using automated speckle tracking software. The regions of interest were generated automatically and Left atrial endocardial border was manually adjusted when required. Left atrial phases definition and Left atrial strain values were measured from the Left atrial longitudinal strain curve according to the European Association of Cardiovascular Imaging (EACVI)/American society of echocardiography (ASE) guidelines. Global LV systolic strain was evaluated, and the software automatically traced the contour of the endocardium at apical three, four and two-chamber views.
3. At the same time, the general clinical data, demographic characteristics, electrocardiogram, chest CT results, troponin I (hsTnI) and brain natriol peptide levels on the day of echocardiographic examination were obtained through the hospital electronic medical record His system.
4. Clinical follow-up was performed 12-18 months after the echocardiographic examination by phone and by electronic health record review. We recorded: 1) persistent cardiac symptoms, 2) interval presentation to the emergency department or hospitalization with cardiac symptoms, and 3) any major adverse cardiac event (myocardial infarction, stroke, revascularization, or death).

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • The First Affiliated Hospital Of Shandong First Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

People who have recovered from mild to moderate COVID-19.

Description

Inclusion Criteria:

• 1. Patients having been diagnosed with SARS-CoV-2 Omicron variant infection based on real-time reverse-transcription polymerase chain reaction (RT-PCR) results; 2. Asymptomatic or mild to moderate COVID-19 patients. 3.COVID-19 patients who came to our hospital for echocardiography within 3 months after recovery.

Exclusion Criteria:

• Patients with decreased left ventricular ejection fraction (less than 50%), left ventricular segmental wall motion abnormalities, cardiomyopathy, severe valvular heart disease, arrhythmia, thyroid dysfunction, pulmonary hypertension, past or current pulmonary embolism, severe chronic obstructive pulmonary disease, malignancy/renal failure (less than 30) ml/min) or poor cardiogram image quality were excluded from the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 group; Patients diagnosed with SARS-CoV-2 Omicron variant infection by SARS-CoV-2 RT-PCR test within 3 months who came to our hospital for echocardiography were included in the case group .	Diagnostic test: two-dimensional speckle tracking echocardiography; The structural and functional parameters of the left atrial were obtained by conventional echocardiography, and the left atrial strain parameters were obtained by two-dimensional speckle tracking echocardiography.
Control group; Healthy participants were confirmed free of COVID-19 disease by reverse transcriptase-polymerase chain reaction (RT-PCR) testing and computed tomography (CT) imaging.	Diagnostic test: two-dimensional speckle tracking echocardiography; The structural and functional parameters of the left atrial were obtained by conventional echocardiography, and the left atrial strain parameters were obtained by two-dimensional speckle tracking echocardiography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left atrial strain	Myocardial strain derived from speckle-tracking echocardiography has been shown to be more sensitive and accurate in detecting subclinical impairment of cardiac function than conventional echocardiography. LV diastolic dysfunction could be explained by Left atrial strain.	After recruiting, left atrial strain collected through software post-processing analysis will be assessed and reported up to 8 weeks.

Collaborators and Investigators

• Sponsor: Haiyan Wang
• Investigators: Principal Investigator: Haiyan Wang, The First Affiliated Hospital Of Shandong First Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Estimated): July 20, 2024
• Study Completion (Estimated): July 20, 2024

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Estimated): December 14, 2023

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; echocardiography; Left atrial strain; Long COVID-19 syndrome; 2-dimensional speckle tracking imaging
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: YXLL-KY-2023(136)

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