Optimized Cardioprotection Therapy in Obese Subjects With AMI

Sponsor

Xijing Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04570514

Collaborator

(none)

120

Enrollment

Location

Anticipated Duration (Months)

40.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction Myocardial Reperfusion Injury Obesity Adiposis; Heart	Procedure: 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 Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Effects and Mechanism of Adipokines Cardiac Protection in Obese Patients With Acute Myocardial Infarction (AMI) Who Have Undergone Percutaneous Coronary Intervention (PCI).

Anticipated Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Oct 1, 2020

Anticipated Study Completion Date :

Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Obesity Patients with Obesity. BMI>=25	Procedure: PCI percutaneous coronary intervention (PCI)
Non-Obesity Patients without Obesity. BMI<25	Procedure: PCI percutaneous coronary intervention (PCI)

Arm

Intervention/Treatment

Obesity

Patients with Obesity. BMI>=25

Procedure: PCI

percutaneous coronary intervention (PCI)

Non-Obesity

Patients without Obesity. BMI<25

Procedure: PCI

percutaneous coronary intervention (PCI)

Outcome Measures

Primary Outcome Measures

Number of patient death during the follow up period [1 year]

Secondary Outcome Measures

Left ventricular ejection fraction [1 year]
Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT) [1 year]
Infarct size 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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