ObeseNCT05277779
EARLY Assessment of MYOcardial Tissue Characteristics in OBESITY (EARLY-MYO-OBESITY)
An observational study of Obese, run by RenJi Hospital at 1 site in China.
Trial summary
EARLY-MYO-OBESITY-CMR is a prospective, three-center, cardiac imaging study to investigate cardiac morphology, function, and tissue phenotypes in a cohort of non-diabetic obese adults, and compare with metabolically healthy non-obese controls. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese
- What is being tested?
- cardiac magnetic resonance(CMR)
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult obese participants without cardiac symptoms or known cardiac disease
Who may be able to join
- age 18-75 years without cardiac symptoms or known cardiac diseas;
- body mass index ≥25 kg/m2
Who cannot join
- coronary artery disease (coronary artery stenosis >50% on angiography or coronary computed tomography, documented myocardial infarction, or a history of coronary artery bypass graft surgery or percutaneous coronary intervention)
- non-ischemic cardiovascular disease, such as idiopathic cardiomyopathy, valvular disease, congenital heart disease, or pulmonary heart diseas
- a left ventricular (LV) ejection fraction of<50% on echocardiography or a history of heart failure
- arrhythmia or the presence of bundle branch block on electrocardiography
- pacemaker or defibrillator implantation
- renal dysfunction with an estimated glomerular filtration rate of <60 mL/min/1.73 m2
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- contraindications to cardiac magnetic resonance (CMR) imaging
- malignancy or life expectancy of less than 2 year
- inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
EARLY-MYO-OBESITY-CMR is a prospective, three-center, cardiac imaging study to investigate cardiac morphology, function, and tissue phenotypes in a cohort of non-diabetic obese adults, and compare with metabolically healthy non-obese controls.
Read the detailed description
- Transthoracic echocardiography was performed to analyze the LV morphology and function.
- CMR was performed within 24 hours of the echocardiographic examination to assess the cardiac morphology , cardiac function, and myocardial tissue characteristics. Standard cine images were acquired to quantify LV function and volume. T1 mapping-derived ECV values were used to detect subtle diffuse fibrosis , and late gadolinium-enhanced (LGE) imaging was used to identify focal fibrosis. Native T2 values were obtained to quantify myocardial edema . Global longitudinal peak systolic strain (GLS) and e' SR were assessed by tissue tracking analysis to detect subclinical systolic and diastolic dysfunction.
- Conditions
- Obese
- Being tested
- cardiac magnetic resonance(CMR)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac magnetic resonance(CMR)Diagnostic test
CMR was performed to assess myocardial tissue characteristics in the study population
| Study group | Role | What they receive |
|---|---|---|
| control | non-obese （BMI<25kg/m2）controls without known endocrine diseases, cardiac disease, or other comorbidities, and with unremarkable imaging results. Receives: Diagnostic Test: cardiac magnetic resonance(CMR) | |
| metabolically healthy obese | obese individuals having no more than one of the metabolic syndrome components (with exception of increased waist circumference) and without impaired glucose tolerance (defined as a 2-hour post loading glucose level of 7.7-11.1mmol/L ) Receives: Diagnostic Test: cardiac magnetic resonance(CMR) | |
| metabolically unhealthy obese | obese individuals with more than one metabolic syndrome components or impaired glucose tolerance Receives: Diagnostic Test: cardiac magnetic resonance(CMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
investigate cardiac morphology and function by CMR
cardiac morphology and function were assessed by CMR steady-state free precession sequences
Measured: 24 hours within recruitment
investigate cardiac tissue characteristics by CMR
myocardial edema and fibrosis were assessed by CMR T2 mapping and ECV
Measured: 24 hours within recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Jan 2019
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo Hangzhou Bay Hospital, Shanghai Jiading Central Hospital
- Responsible party
- Sponsor
- Investigators
- Meng Jiang, Study director, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277779
- Sponsor's protocol ID
- ACFO2021
- Status last verified
- Feb 2022
- First submitted
- 3 Mar 2022
- Last updated
- 1 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao H, Huang R, Jiang M, Wang W, Chai Y, Liu Q, Zhang W, Han Y, Yan F, Lu Q, Tao Z, Wu Q, Yue J, Ma J, Pu J. Myocardial Tissue-Level Characteristics of Adults With Metabolically Healthy Obesity. JACC Cardiovasc Imaging. 2023 Jul;16(7):889-901. doi: 10.1016/j.jcmg.2023.01.022. Epub 2023 Apr 12.
PubMed 37052557
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EARLY Assessment of MYOcardial Tissue Characteristics in OBESITY (EARLY-MYO-OBESITY)
- ClinicalTrials.gov ID
- NCT05277779
- Acronym / sponsor ID
- ACFO2021
- Conditions
- Obese
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Ningbo Hangzhou Bay Hospital, Shanghai Jiading Central Hospital
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 14 Mar 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.
EARLY-MYO-OBESITY-CMR is a prospective, three-center, cardiac imaging study to investigate cardiac morphology, function, and tissue phenotypes in a cohort of non-diabetic obese adults, and compare with metabolically healthy non-obese controls.
Detailed description
- Transthoracic echocardiography was performed to analyze the LV morphology and function.
- CMR was performed within 24 hours of the echocardiographic examination to assess the cardiac morphology , cardiac function, and myocardial tissue characteristics. Standard cine images were acquired to quantify LV function and volume. T1 mapping-derived ECV values were used to detect subtle diffuse fibrosis , and late gadolinium-enhanced (LGE) imaging was used to identify focal fibrosis. Native T2 values were obtained to quantify myocardial edema . Global longitudinal peak systolic strain (GLS) and e' SR were assessed by tissue tracking analysis to detect subclinical systolic and diastolic dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | – | Diagnostic Test: cardiac magnetic resonance(CMR)non-obese （BMI<25kg/m2）controls without known endocrine diseases, cardiac disease, or other comorbidities, and with unremarkable imaging results. |
| metabolically healthy obese | – | Diagnostic Test: cardiac magnetic resonance(CMR)obese individuals having no more than one of the metabolic syndrome components (with exception of increased waist circumference) and without impaired glucose tolerance (defined as a 2-hour post loading glucose level of 7.7-11.1mmol/L ) |
| metabolically unhealthy obese | – | Diagnostic Test: cardiac magnetic resonance(CMR)obese individuals with more than one metabolic syndrome components or impaired glucose tolerance |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult obese participants without cardiac symptoms or known cardiac disease
Key inclusion criteria (2 listed)
- age 18-75 years without cardiac symptoms or known cardiac diseas;
- body mass index ≥25 kg/m2
Key exclusion criteria (9 listed)
- coronary artery disease (coronary artery stenosis >50% on angiography or coronary computed tomography, documented myocardial infarction, or a history of coronary artery bypass graft surgery or percutaneous coronary intervention)
- non-ischemic cardiovascular disease, such as idiopathic cardiomyopathy, valvular disease, congenital heart disease, or pulmonary heart diseas
- a left ventricular (LV) ejection fraction of<50% on echocardiography or a history of heart failure
- arrhythmia or the presence of bundle branch block on electrocardiography
- pacemaker or defibrillator implantation
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 |
|---|---|---|
| cardiac magnetic resonance(CMR)CMR was performed to assess myocardial tissue characteristics in the study population | Diagnostic test | control, metabolically healthy obese, metabolically unhealthy obese |
Primary outcome
investigate cardiac morphology and function by CMR
Time frame: 24 hours within recruitment
cardiac morphology and function were assessed by CMR steady-state free precession sequences
investigate cardiac tissue characteristics by CMR
Time frame: 24 hours within recruitment
myocardial edema and fibrosis were assessed by CMR T2 mapping and ECV
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Derived from this study: PubMed 37052557Zhao H, Huang R, Jiang M, Wang W, Chai Y, Liu Q, Zhang W, Han Y, Yan F, Lu Q, Tao Z, Wu Q, Yue J, Ma J, Pu J. Myocardial Tissue-Level Characteristics of Adults With Metabolically Healthy Obesity. JACC Cardiovasc Imaging. 2023 Jul;16(7):889-901. doi: 10.1016/j.jcmg.2023.01.022. Epub 2023 Apr 12.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Meng Jiang study director
RenJi 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 Obese, run by RenJi 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 1 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
investigate cardiac morphology and function by CMR (time frame: 24 hours within recruitment). 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 NCT05277779, which also lists 1 linked publication.
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 1 Jun 2023.