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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05277779
Enrollment
120
Registered
2022-03-14
Start date
2019-01-01
Completion date
2022-12-30
Last updated
2023-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese

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.

Interventions

DIAGNOSTIC_TESTcardiac magnetic resonance(CMR)

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

Sponsors

Ningbo Hangzhou Bay Hospital
CollaboratorUNKNOWN
Shanghai Jiading Central Hospital
CollaboratorUNKNOWN
RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
investigate cardiac morphology and function by CMR24 hours within recruitmentcardiac morphology and function were assessed by CMR steady-state free precession sequences
investigate cardiac tissue characteristics by CMR24 hours within recruitmentmyocardial edema and fibrosis were assessed by CMR T2 mapping and ECV

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026