Normal Values of Cardiac Measurements by Echocardiography in Chinese Based on Artificial Intelligence

Normal Reference Values of Cardiac Measurements by Echocardiography in Chinese Han Adults Based on Artificial Intelligence: A Multi-center Study in China

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

Study Overview

• Status: Completed
• Conditions: Heart Chambers
• Intervention / Treatment: Other: Echocardiography

Detailed Description

We will establish normal reference values for the volume, function and strain of various heart chambers of Chinese people based on the recruitment of healthy Chinese subjects.

• Study Type: Observational
• Enrollment (Actual): 2000

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Chinese Han healthy adults

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tianxin Dong

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-445

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No