NCT06170307

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2024

Completed
Last Updated

December 17, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

December 11, 2023

Last Update Submit

December 12, 2024

Conditions

Keywords

COVID-19Long COVID-19 syndrome2-dimensional speckle tracking imagingechocardiographyLeft atrial strain

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

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 .

Other: 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.

Other: two-dimensional speckle tracking echocardiography

Interventions

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.

COVID-19 groupControl group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \. 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250000, China

Location

Related Publications (1)

  • Zhou B, Zhang Y, Han S, Zhang J, Song L, Wang H. Myocardial Dysfunction and Risk of Long COVID in Patients Recovered From Mild and Moderate COVID-19. Echocardiography. 2025 Mar;42(3):e70120. doi: 10.1111/echo.70120.

MeSH Terms

Conditions

COVID-19Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Haiyan Wang

    Shandong First Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 11, 2023

First Posted

December 14, 2023

Study Start

November 20, 2023

Primary Completion

July 20, 2024

Study Completion

August 20, 2024

Last Updated

December 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations