## Protocol Section
### Identification Module
**NCT ID:** NCT05277779

**Brief Title:** EARLY Assessment of MYOcardial Tissue Characteristics in OBESITY (EARLY-MYO-OBESITY)

**Official Title:** EARLY Assessment of MYOcardial Tissue Characteristics in OBESITY (EARLY-MYO-OBESITY)

#### Organization Study ID Info
**ID:** ACFO2021
#### Organization
**Class:** OTHER
**Full Name:** RenJi Hospital
### Status Module
#### Completion Date
**Date:** 2022-12-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-06-01

**Type:** ACTUAL

**Last Update Submit Date:** 2023-05-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-12-30

**Type:** ACTUAL

#### Start Date
**Date:** 2019-01-01

**Type:** ACTUAL

**Status Verified Date:** 2022-02

#### Study First Post Date
**Date:** 2022-03-14
**Type:** ACTUAL
**Study First Submit Date:** 2022-03-03
**Study First Submit QC Date:** 2022-03-03
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Ningbo Hangzhou Bay Hospital

**Class:** UNKNOWN

**Name:** Shanghai Jiading Central Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** RenJi Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Obese

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 120

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** non-obese （BMI\<25kg/m2）controls without known endocrine diseases, cardiac disease, or other comorbidities, and with unremarkable imaging results.

**Intervention Names:**

- Diagnostic Test: cardiac magnetic resonance(CMR)

**Label:** control

#### Arm Group 2

**Description:** 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 )

**Intervention Names:**

- Diagnostic Test: cardiac magnetic resonance(CMR)

**Label:** metabolically healthy obese

#### Arm Group 3

**Description:** obese individuals with more than one metabolic syndrome components or impaired glucose tolerance

**Intervention Names:**

- Diagnostic Test: cardiac magnetic resonance(CMR)

**Label:** metabolically unhealthy obese

### Interventions

#### Intervention 1

**Arm Group Labels:**

- control

- metabolically healthy obese

- metabolically unhealthy obese

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

**Name:** cardiac magnetic resonance(CMR)

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

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

**Measure:** investigate cardiac morphology and function by CMR

**Time Frame:** 24 hours within recruitment

**Description:** myocardial edema and fibrosis were assessed by CMR T2 mapping and ECV

**Measure:** investigate cardiac tissue characteristics by CMR

**Time Frame:** 24 hours within recruitment

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adult obese participants without cardiac symptoms or known cardiac disease

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Shanghai

**Country:** China

**Facility:** Renji Hospital

**State:** Shanghai

**Zip:** 200127

#### Overall Officials

**Official 1:**

**Affiliation:** Renji Hospital, Shanghai

**Name:** Meng Jiang

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000050177

- Term: Overweight

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: HIGH

- As Found: Obesity

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009765

- Term: Obesity

### Misc Info Module

- Version Holder: 2024-05-24
