Clinical trial NCT05277779: EARLY Assessment of MYOcardial Tissue Characteristics in OBESITY (EARLY-MYO-OBESITY)
Official title: EARLY Assessment of MYOcardial Tissue Characteristics in OBESITY (EARLY-MYO-OBESITY)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obese
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Ningbo Hangzhou Bay Hospital
name: Shanghai Jiading Central Hospital
First posted: 2022-03-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult obese participants without cardiac symptoms or known cardiac disease

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.

Eligibility criteria: 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

Primary outcomes:
measure: investigate cardiac morphology and function by CMR
timeFrame: 24 hours within recruitment
measure: investigate cardiac tissue characteristics by CMR
timeFrame: 24 hours within recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: Renji Hospital, Shanghai
name: Meng Jiang
role: STUDY_DIRECTOR
References: