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

Completed

• Conditions: Obese
• Interventions: Diagnostic Test: cardiac magnetic resonance(CMR)

• Registration Number: NCT05277779
• Lead Sponsor: RenJi Hospital

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.

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 Timeline

• Study Start: 2019-01-01
• Status Verified: 2022-02
• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-14
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
metabolically unhealthy obese	cardiac magnetic resonance(CMR)	obese individuals with more than one metabolic syndrome components or impaired glucose tolerance
control	cardiac magnetic resonance(CMR)	non-obese （BMI\<25kg/m2）controls without known endocrine diseases, cardiac disease, or other comorbidities, and with unremarkable imaging results.
metabolically healthy obese	cardiac magnetic resonance(CMR)	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 )

Primary Outcome Measures

Name	Time	Method
investigate cardiac morphology and function by CMR	24 hours within recruitment	cardiac morphology and function were assessed by CMR steady-state free precession sequences
investigate cardiac tissue characteristics by CMR	24 hours within recruitment	myocardial edema and fibrosis were assessed by CMR T2 mapping and ECV

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China