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

Obese Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05277779
• Other study ID #: ACFO2021
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2022
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obese
• Obesity

Intervention

Diagnostic Test:
• cardiac magnetic resonance(CMR)
CMR was performed to assess myocardial tissue characteristics in the study population

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
RenJi Hospital	Ningbo Hangzhou Bay Hospital, Shanghai Jiading Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	investigate cardiac morphology and function by CMR	cardiac morphology and function were assessed by CMR steady-state free precession sequences	24 hours within recruitment
Primary	investigate cardiac tissue characteristics by CMR	myocardial edema and fibrosis were assessed by CMR T2 mapping and ECV	24 hours within recruitment