Cardiac Normal Values Assessed by Magnetic Resonance Imaging

Recruiting

• Conditions: Healthy Participants; Reference Values

• Registration Number: NCT05346094
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary

This study carried out a study enrolled healthy volunteers to comprehensively provide age and sex specific reference values of the normal cardiac structure and function of Chinese adults, using the steady-state free precession technique (SSFP) as well as reference values for novel cardiovascular magnetic resonance techniques including myocardial strian and tissue characterization.

Detailed Description

Cardiovascular magnetic resonance (CMR), as a non-invasive and radiation-free examination, can identify the structural and functional abnormalities of various cardiovascular diseases. It is the gold standard for cardiovascular structural and functional measurements, and recommended as a priority examination for cardiovascular diseases by guidelines of the American College of Cardiology (ACC/AHA) and the European College of Cardiology (ESC). The reference standard for cardiovascular structure and function of normal people is the basis for cardiovascular disease study, and plays a vital role in diagnosis, differential diagnosis, and prognosis evaluation. CMR parameters have been shown to provide significant information for the general population and have always been important biomarkers for morbidity and mortality in patients with cardiac pathologies. Although there are relevant reference standards for normal values in the world, there is no standard for normal values of large samples of Chinese people. In addition, most of the normal values are limited to traditional parameters of cardiac structure and function, and there is no normal value standard for novel parameters including myocardial strain and tissue characteristics. Therefore, on the basis of previous works, our group planned to create a cardiovascular MRI reference value database of normal Chinese people through retrospective and prospective recruitment, which will lay a foundation for the early identification and prognosis assessment of cardiovascular diseases, and promote the progress of systematic cardiovascular magnetic resonance studies.

Study Timeline

• Study First Submitted: 2021-08-02
• Study Start: 2022-01-01
• Study First Submitted QC: 2022-04-20
• Study First Posted: 2022-04-26
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-04
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 938

Inclusion Criteria

Subjects without cardiovascular disease, cardiovascular related symptoms and risk factors judged by combining clinical manifestations, non-invasive imaging and laboratory examination

Exclusion Criteria

• Subjects clinically screened or previously diagnosed with cardiovascular disease and risk factors
• Subjects with serious non-cardiovascular diseases
• Subjects with poor quality of magnetic resonance imaging
• Subjects refused to participate in the study
• Subjects with contraindications to MRI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Normal values of novel cardiovascular magnetic resonance parameters	5 years	Create a database for normal values of novel cardiovascular magnetic resonance parameters
Normal values of left and right structures and cardiac function	5 years	Create a database for normal values of left and right structures and cardiac function

Trial Locations

Locations (1)

Fuwai Hospital; 🇨🇳 Beijing, Beijing, China