Healthy ParticipantsNCT05346094
Cardiac Normal Values Assessed by Magnetic Resonance Imaging
An observational study of Healthy Participants and Reference Values, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages Up to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Reference Values
- How many people
- 938 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy subjects without cardiovascular disease, cardiovascular related symptoms and risk factors judged by combining clinical manifestations, non-invasive imaging and laboratory examination
Who may be able to join
- Subjects without cardiovascular disease, cardiovascular related symptoms and risk factors judged by combining clinical manifestations, non-invasive imaging and laboratory examination
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality, 100037
Minjie Lu, PhD, +86 10 88398175, coolkan@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Participants, Reference Values
- Being tested
- No intervention
- Keywords
- reference values, morphology, function, tissue characterization, myocardial deformation, cardiocascular magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal values of left and right structures and cardiac function
Create a database for normal values of left and right structures and cardiac function
Measured: 5 years
Normal values of novel cardiovascular magnetic resonance parameters
Create a database for normal values of novel cardiovascular magnetic resonance parameters
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 938 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minjie Lu, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Minjie Lu, Study chair, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346094
- Sponsor's protocol ID
- CMR_Normal
- Status last verified
- Jan 2023
- First submitted
- 2 Aug 2021
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28942735von 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.
PubMed 26800662Zhou 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.
PubMed 32394180Bruder 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.
PubMed 23331632Klinke 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.
PubMed 23787094Bruder 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.
PubMed 22093267Global 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.
PubMed 28187739Esposito 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.
PubMed 32964326
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Investigation of Cardiac Normal Values of Morphology, Function and Tissue Characteristics by Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT05346094
- Acronym / sponsor ID
- CMR_Normal
- Conditions
- Healthy Participants, Reference Values
- Keywords
- reference values, morphology, function, tissue characterization, myocardial deformation, cardiocascular magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 938 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy subjects without cardiovascular disease, cardiovascular related symptoms and risk factors judged by combining clinical manifestations, non-invasive imaging and laboratory examination
Key inclusion criteria (1 listed)
- Subjects without cardiovascular disease, cardiovascular related symptoms and risk factors judged by combining clinical manifestations, non-invasive imaging and laboratory examination
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
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
Normal values of novel cardiovascular magnetic resonance parameters
Time frame: 5 years
Create a database for normal values of novel cardiovascular magnetic resonance parameters
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Results publication: PubMed 28942735von 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.
- Results publication: PubMed 26800662von 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.
- Results publication: PubMed 32394180Zhou 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.
- Results publication: PubMed 23331632Bruder 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.
- Results publication: PubMed 23787094Klinke 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.
- Results publication: PubMed 22093267Bruder 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.
- Results publication: PubMed 28187739Global 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.
- Results publication: PubMed 32964326Esposito 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Minjie Lu study chair
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Participants and Reference Values, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minjie Lu (13681042022, coolkan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal values of left and right structures and cardiac function (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05346094, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.