NCT05277779

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2019

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

June 1, 2023

Status Verified

February 1, 2022

Enrollment Period

4 years

First QC Date

March 3, 2022

Last Update Submit

May 30, 2023

Conditions

Obese

Outcome Measures

Primary Outcomes (2)

  • investigate cardiac morphology and function by CMR

    cardiac morphology and function were assessed by CMR steady-state free precession sequences

    24 hours within recruitment

  • investigate cardiac tissue characteristics by CMR

    myocardial edema and fibrosis were assessed by CMR T2 mapping and ECV

    24 hours within recruitment

Study Arms (3)

control

non-obese （BMI\<25kg/m2）controls without known endocrine diseases, cardiac disease, or other comorbidities, and with unremarkable imaging results.

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 )

Diagnostic Test: cardiac magnetic resonance(CMR)

metabolically unhealthy obese

obese individuals with more than one metabolic syndrome components or impaired glucose tolerance

Diagnostic Test: cardiac magnetic resonance(CMR)

Interventions

cardiac magnetic resonance(CMR)DIAGNOSTIC_TEST

CMR was performed to assess myocardial tissue characteristics in the study population

controlmetabolically healthy obesemetabolically unhealthy obese

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult obese participants without cardiac symptoms or known cardiac disease

You may qualify if:

  • age 18-75 years without cardiac symptoms or known cardiac diseas;
  • body mass index ≥25 kg/m2

You may not qualify if:

  • 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
  • contraindications to cardiac magnetic resonance (CMR) imaging
  • malignancy or life expectancy of less than 2 year
  • inability to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (1)

  • 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.

    PMID: 37052557DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Meng Jiang

    RenJi Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2022

First Posted

March 14, 2022

Study Start

January 1, 2019

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

June 1, 2023

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)