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

Shanghai Jiao Tong University

Status: Completed

Conditions: Obese

Treatments: Diagnostic Test: cardiac magnetic resonance(CMR)

Study type: Observational

Funder types: Other

Identifiers

NCT05277779

ACFO2021

Details and patient eligibility

About

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.

Full description

1. Transthoracic echocardiography was performed to analyze the LV morphology and function.
2. 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

120 participants in 3 patient groups

control

Description:

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

Treatment:

Diagnostic Test: cardiac magnetic resonance(CMR)

metabolically healthy obese

Description:

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 )

Treatment:

Diagnostic Test: cardiac magnetic resonance(CMR)

metabolically unhealthy obese

Description:

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

Treatment:

Diagnostic Test: cardiac magnetic resonance(CMR)