Optimized Cardioprotection Therapy in Obese Subjects With CAD

• Conditions: Obesity; Adiposis; Heart; Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
• Interventions: Procedure: PCI

• Registration Number: NCT04570527
• 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 coronary artery disease (CAD).

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 coronary artery disease (CAD). Reperfusion therapy such as percutaneous coronary intervention (PCI) should be administered to all eligible patients with CAD symptom. 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 coronary artery disease (CAD).

Study Timeline

• Study Start: 2019-01-01
• 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
• Primary Completion: 2021-10-01
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

coronary artery disease according to the WHO definition With or without percutaneous coronary intervention

Exclusion Criteria

previous Coronary artery bypass grafting (CABG) 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	BMI\>=25
Non-Obesity	PCI	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
Left ventricular ejection fraction	1 year
Number of target vessel revascularization	1 year
six-min walk distance (6MWD)	1 year
Angina class according to the canadian cardiovascular society (CCS) classification	1 year
Scores on the Seattle angina questionnaire	1 year

Trial Locations

Locations (1)

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