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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-12-30

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.

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Detailed Description

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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.

Conditions

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Obese

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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control

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

cardiac magnetic resonance(CMR)

Intervention Type DIAGNOSTIC_TEST

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

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 )

cardiac magnetic resonance(CMR)

Intervention Type DIAGNOSTIC_TEST

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

metabolically unhealthy obese

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

cardiac magnetic resonance(CMR)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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cardiac magnetic resonance(CMR)

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

Intervention Type DIAGNOSTIC_TEST

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes