Optimized Cardioprotection Therapy in Obese Subjects With CAD

Obesity Clinical Trial

Official title:

Effects and Mechanism of Adipokines Cardiac Protection in Obese Patients With Coronary Artery Disease (CAD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04570527
• Other study ID #: OB-CAD
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2020
• Source: Xijing Hospital
• Contact: Dongdong Sun, MD, PhD
• Phone: 86 29 84775183
• Email: wintersun3[@]gmail.com
• 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 coronary artery disease (CAD).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Adiposis; Heart
• Coronary Artery Disease
• Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
• Coronary Disease
• Heart Diseases
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• Obesity

Intervention

Procedure:
• PCI
percutaneous coronary intervention

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	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