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Completed

NCT Number: NCT05277779

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

About this study

  • Transthoracic echocardiography was performed to analyze the LV morphology and function.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiac magnetic resonance(CMR)

Diagnostic Test

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

Primary outcomes

  1. investigate cardiac morphology and function by CMR

    Time frame: 24 hours within recruitment

    cardiac morphology and function were assessed by CMR steady-state free precession sequences

  2. investigate cardiac tissue characteristics by CMR

    Time frame: 24 hours within recruitment

    myocardial edema and fibrosis were assessed by CMR T2 mapping and ECV

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

  • Ningbo Hangzhou Bay Hospital
  • Shanghai Jiading Central Hospital

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 14, 2022
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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