Cardiac Normal Values Assessed by Magnetic Resonance Imaging

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05346094
• Other study ID #: CMR_Normal
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: June 30, 2027

Study information

• Verified date: January 2023
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Minjie Lu
• Phone: 13681042022
• Email: coolkan[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 938
• Est. completion date: June 30, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants
• Reference Values

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

Bruder O, Schneider S, Nothnagel D, Pilz G, Lombardi M, Sinha A, Wagner A, Dill T, Frank H, van Rossum A, Schwitter J, Nagel E, Senges J, Sabin G, Sechtem U, Mahrholdt H. Acute adverse reactions to gadolinium-based contrast agents in CMR: multicenter expe — View Citation

Bruder O, Wagner A, Lombardi M, Schwitter J, van Rossum A, Pilz G, Nothnagel D, Steen H, Petersen S, Nagel E, Prasad S, Schumm J, Greulich S, Cagnolo A, Monney P, Deluigi CC, Dill T, Frank H, Sabin G, Schneider S, Mahrholdt H. European Cardiovascular Magn — View Citation

Esposito A, Gallone G, Palmisano A, Marchitelli L, Catapano F, Francone M. The current landscape of imaging recommendations in cardiovascular clinical guidelines: toward an imaging-guided precision medicine. Radiol Med. 2020 Nov;125(11):1013-1023. doi: 10 — View Citation

Global Cardiovascular Magnetic Resonance Registry (GCMR) Investigators, Kwong RY, Petersen SE, Schulz-Menger J, Arai AE, Bingham SE, Chen Y, Choi YL, Cury RC, Ferreira VM, Flamm SD, Steel K, Bandettini WP, Martin ET, Nallamshetty L, Neubauer S, Raman SV, — View Citation

Klinke V, Muzzarelli S, Lauriers N, Locca D, Vincenti G, Monney P, Lu C, Nothnagel D, Pilz G, Lombardi M, van Rossum AC, Wagner A, Bruder O, Mahrholdt H, Schwitter J. Quality assessment of cardiovascular magnetic resonance in the setting of the European C — View Citation

von Knobelsdorff-Brenkenhoff F, Pilz G, Schulz-Menger J. Representation of cardiovascular magnetic resonance in the AHA / ACC guidelines. J Cardiovasc Magn Reson. 2017 Sep 25;19(1):70. doi: 10.1186/s12968-017-0385-z. — View Citation

von Knobelsdorff-Brenkenhoff F, Schulz-Menger J. Role of cardiovascular magnetic resonance in the guidelines of the European Society of Cardiology. J Cardiovasc Magn Reson. 2016 Jan 22;18:6. doi: 10.1186/s12968-016-0225-6. — View Citation

Zhou D, Xu J, Zhao S, Lu M. CMR publications from China of the last more than 30 years. Int J Cardiovasc Imaging. 2020 Sep;36(9):1737-1747. doi: 10.1007/s10554-020-01873-x. Epub 2020 May 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normal values of left and right structures and cardiac function	Create a database for normal values of left and right structures and cardiac function	5 years
Primary	Normal values of novel cardiovascular magnetic resonance parameters	Create a database for normal values of novel cardiovascular magnetic resonance parameters	5 years