NCT05346094

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
938

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress79%
Jan 2022Jun 2027

First Submitted

Initial submission to the registry

August 2, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

5 years

First QC Date

August 2, 2021

Last Update Submit

January 3, 2023

Conditions

Keywords

reference valuesmorphologyfunctiontissue characterizationmyocardial deformationcardiocascular magnetic resonance imaging

Outcome Measures

Primary Outcomes (2)

  • 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

  • Normal values of novel cardiovascular magnetic resonance parameters

    Create a database for normal values of novel cardiovascular magnetic resonance parameters

    5 years

Interventions

No intervention

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (8)

  • 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.

  • 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.

  • 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.

  • 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 Magnetic Resonance (EuroCMR) registry--multi national results from 57 centers in 15 countries. J Cardiovasc Magn Reson. 2013 Jan 18;15(1):9. doi: 10.1186/1532-429X-15-9.

  • 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 CMR registry: description and validation of standardized criteria. J Cardiovasc Magn Reson. 2013 Jun 20;15(1):55. doi: 10.1186/1532-429X-15-55.

  • 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 experience with 17,767 patients from the EuroCMR Registry. JACC Cardiovasc Imaging. 2011 Nov;4(11):1171-6. doi: 10.1016/j.jcmg.2011.06.019.

  • 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, Schelbert EB, Valeti US, Cao JJ, Reichek N, Young AA, Fexon L, Pivovarov M, Ferrari VA, Simonetti OP. The global cardiovascular magnetic resonance registry (GCMR) of the society for cardiovascular magnetic resonance (SCMR): its goals, rationale, data infrastructure, and current developments. J Cardiovasc Magn Reson. 2017 Jan 20;19(1):23. doi: 10.1186/s12968-016-0321-7.

  • 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: 10.1007/s11547-020-01286-9. Epub 2020 Sep 22.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

Study Officials

  • Minjie Lu

    Chinese Academy of Medical Sciences, Fuwai Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Doctor

Study Record Dates

First Submitted

August 2, 2021

First Posted

April 26, 2022

Study Start

January 1, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

January 4, 2023

Record last verified: 2023-01

Locations