EARLY Assessment of MYOcardial Tissue Characteristics in OBESITY (EARLY-MYO-OBESITY-II)
Study Details
Study Description
Brief Summary
EARLY-MYO-OBESITY-II is a prospective, single-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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| control non-obese （BMI<25kg/m2）controls without known endocrine diseases, cardiac disease, or other comorbidities, and with unremarkable imaging results. |
Diagnostic Test: cardiac magnetic resonance(CMR)
CMR was performed to assess myocardial tissue characteristics in the study population
|
| metabolically healthy obese 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 ) |
Diagnostic Test: cardiac magnetic resonance(CMR)
CMR was performed to assess myocardial tissue characteristics in the study population
|
| metabolically unhealthy obese obese individuals with more than one metabolic syndrome components or impaired glucose tolerance |
Diagnostic Test: cardiac magnetic resonance(CMR)
CMR was performed to assess myocardial tissue characteristics in the study population
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
- all patients were 18 to 75 years old without any cardiac symptoms.
-
- body mass index (BMI) ≥ 25kg/m2.
Exclusion Criteria:
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- diagnosis of diabetic mellitus according to the American Diabetes Association criteria, or current treatment for diabetic mellitus; 2) coronary disease (coronary artery stenosis >50% on coronary computed tomography or document myocardial infarction), or coronary artery stenosis >50% on angiography in Framingham risk score
10% or segmental wall motion abnormalities on echocardiography; 3) LVEF <50% on echocardiography or history of HF; 4) severe valvular stenosis or regurgitation; 4) arrhythmia or the presence of bundle branch block on electrocardiogram; 5) pacemaker or defibrillator implantation; 6) renal dysfunction with an estimated glomerular filtration rate <60 ml/min/1.73 m2 or other contraindications to CMR; 7) no signed consent, tumor, or life expectancy less than 2 years.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Renji Hospital | Shanghai | Shanghai | China | 200127 |
Sponsors and Collaborators
- RenJi Hospital
Investigators
- Study Director: Meng Jiang, Renji Hospital, Shanghai
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ACFO2021