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

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.

Study Overview

• Status: Completed
• Conditions: Obese
• Intervention / Treatment: Diagnostic test: cardiac magnetic resonance(CMR)

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Renji hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult obese participants without cardiac symptoms or known cardiac disease

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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 )	Diagnostic test: cardiac magnetic resonance(CMR); 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	Diagnostic test: cardiac magnetic resonance(CMR); CMR was performed to assess myocardial tissue characteristics in the study population

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: Ningbo Hangzhou Bay Hospital; Shanghai Jiading Central Hospital
• Investigators: Study Director: Meng Jiang, Renji Hospital, Shanghai

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: ACFO2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No