EARLY Assessment of MYOcardial Tissue Characteristics in OBESITY (EARLY-MYO-OBESITY)

Study Overview
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Brief Summary
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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
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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.

Official Title
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EARLY Assessment of MYOcardial Tissue Characteristics in OBESITY (EARLY-MYO-OBESITY)

Conditions
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Obese

Intervention / Treatment
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* Diagnostic Test: cardiac magnetic resonance(CMR)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: age 18-75 years without cardiac symptoms or known cardiac diseas; body mass index ≥25 kg/m2 Exclusion criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control<br>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)<br>* CMR was performed to assess myocardial tissue characteristics in the study population<br>|
| metabolically healthy obese<br>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)<br>* CMR was performed to assess myocardial tissue characteristics in the study population<br>|
| metabolically unhealthy obese<br>obese individuals with more than one metabolic syndrome components or impaired glucose tolerance | Diagnostic Test: cardiac magnetic resonance(CMR)<br>* CMR was performed to assess myocardial tissue characteristics in the study population<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |