Optimized Cardioprotection Therapy in Obese Subjects With AMI

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04570514
• Other study ID #: OB-AMI
• Status: Not yet recruiting
• Start date: October 1, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: September 2020
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 30, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Adiposis; Heart
• Infarction
• Myocardial Infarction
• Myocardial Reperfusion Injury
• Obesity
• Reperfusion Injury

Intervention

Procedure:
• PCI
percutaneous coronary intervention (PCI)

Locations

Country	Name	City	State
China	Xijing hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patient death during the follow up period		1 year
Secondary	Left ventricular ejection fraction		1 year
Secondary	Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT)		1 year
Secondary	Infarct size as evaluated by Single-photon emission computed tomography (SPECT)		1 year
Secondary	Number of target vessel revascularization		1 year
Secondary	Angina class according to the canadian cardiovascular society (CCS) classification		1 year
Secondary	Scores on the Seattle angina questionnaire		1 year
Secondary	six-min walk distance (6MWD)		1 year