NCT06234241

Brief Summary

Establish echocardiographic normal reference values of Chinese Han adults based on artificial intelligence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 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

June 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

January 23, 2024

Last Update Submit

January 23, 2024

Conditions

Heart Chambers

Outcome Measures

Primary Outcomes (3)

  • Cardiac volumes

    Including the left and right atria and left and right ventricles

    2024-10-31

  • Cardiac Function

    Including the left and right atria and left and right ventricles

    2024-10-31

  • Cardiac strain

    Including the left and right atria and left and right ventricles

    2024-10-31

Interventions

EchocardiographyOTHER

Echocardiography was performed in all enrolled populations.

Eligibility Criteria

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

Chinese Han healthy adults

You may qualify if:

  • Age ≥ 18 years; No history or clinical evidence of cardiac, cardiovascular, lung, or kidney disease; No abnormal findings on physical examination, biochemical examination, electrocardiography, or echocardiography.

You may not qualify if:

  • Hypertension (blood pressure \[BP\] \> 140/80 mmHg) or receiving medication for hypertension; body mass index \> 30 kg/m2; total cholesterol ≥ 6.2 mmol/L, triglyceride ≥ 2.3 mmol/L, or high-density lipoprotein cholesterol \< 1.0 mmol/L; endocrine diseases, such as diabetes mellitus (fasting blood glucose ≥ 7.0 mmol/L), thyroid disease, pheochromocytoma, adrenal insufficiency, and hyperaldosteronism; anemia; abnormal liver function; connective tissue diseases, such as rheumatoid arthritis, vasculitis, systemic lupus erythematosus, dermatomyositis, and scleroderma; malignancy; current pregnancy or lactation; professional sport activity; and a history of alcoholism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 23, 2024

First Posted

January 31, 2024

Study Start

June 1, 2023

Primary Completion

October 31, 2023

Study Completion

December 31, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations

CN(1)