Optimized Cardioprotection Therapy in Obese Subjects With AMI

• Conditions: Acute Myocardial Infarction; Myocardial Reperfusion Injury; Obesity; Adiposis; Heart
• Interventions: Procedure: PCI

• Registration Number: NCT04570514
• Lead Sponsor: Xijing Hospital

Brief Summary

The purpose of this study is to investigate the efficacy and mechanism of Adipokines Cardiac Protection in Obese Patients With acute myocardial infarction (AMI) Who Have Undergone Percutaneous Coronary Intervention (PCI).

Detailed Description

Adipokines (or adipocytokines) can be defined as a group of more than 600 bioactive molecules made from adipose tissue that acts as paracrine and endocrine hormones. Adipokines are involved in maintaining varieties of processes such as, appetite and satiety, energy expenditure activity, endothelial function, blood pressure, hemostasis, adipogenesis, insulin sensitivity, energy metabolism in insulin-sensitive tissues, fat distribution and insulin secretion in pancreatic β-cells. Adipokines may contribute to reduce scar formation and improve cardiac function in acute myocardial infarction (AMI). Reperfusion therapy such as percutaneous coronary intervention (PCI) should be administered to all eligible patients with AMI symptom onset within the prior 12 hours. However, our previous work showed that obese patients may benefit more from PCI. Thus, the aim of the present study was to investigate the efficacy and mechanism of adipokines cardiac protection for obese and non-obese patients with acute myocardial infarction (AMI) who have undergone PCI.

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-25
• Study First Submitted QC: 2020-09-25
• Last Update Submitted: 2020-09-25
• Study First Posted: 2020-09-30
• Last Update Posted: 2020-09-30
• Study Start: 2020-10-01
• Primary Completion: 2020-10-01
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

age between 20 and 70 years old STEMI and NSTMI according to the WHO definition PCI <12 hours from the onset of symptoms

Exclusion Criteria

previous myocardial infarction (MI) cardiomyopathy atrial fibrillation or flutter previous heart surgery severe valvular heart disease disease of the hematopoietic system NYHA functional class IV heart failure at baseline severe renal, lung and liver disease cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obesity	PCI	Patients with Obesity. BMI\>=25
Non-Obesity	PCI	Patients without Obesity. BMI\<25

Primary Outcome Measures

Name	Time	Method
Number of patient death during the follow up period	1 year

Secondary Outcome Measures

Name	Time	Method
Infarct size as evaluated by Single-photon emission computed tomography (SPECT)	1 year
Left ventricular ejection fraction	1 year
Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT)	1 year
Number of target vessel revascularization	1 year
Angina class according to the canadian cardiovascular society (CCS) classification	1 year
Scores on the Seattle angina questionnaire	1 year
six-min walk distance (6MWD)	1 year

Trial Locations

Locations (1)

Xijing hospital; 🇨🇳 Xi'an, Shaanxi, China