Cardiac Normal Values Assessed by Magnetic Resonance Imaging

January 3, 2023 updated by: Minjie Lu, Chinese Academy of Medical Sciences, Fuwai Hospital

A Multicenter Investigation of Cardiac Normal Values of Morphology, Function and Tissue Characteristics by Magnetic Resonance Imaging

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

938

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Fuwai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normal values of left and right structures and cardiac function
Time Frame: 5 years
Create a database for normal values of left and right structures and cardiac function
5 years
Normal values of novel cardiovascular magnetic resonance parameters
Time Frame: 5 years
Create a database for normal values of novel cardiovascular magnetic resonance parameters
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

  • Study Chair: Minjie Lu, Fuwai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

December 31, 2026

Study Completion (Anticipated)

June 30, 2027

Study Registration Dates

First Submitted

August 2, 2021

First Submitted That Met QC Criteria

April 20, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CMR_Normal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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