Clinical trial NCT04570514: Optimized Cardioprotection Therapy in Obese Subjects With AMI
Official title: Effects and Mechanism of Adipokines Cardiac Protection in Obese Patients With Acute Myocardial Infarction (AMI) Who Have Undergone Percutaneous Coronary Intervention (PCI).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myocardial Infarction
Myocardial Reperfusion Injury
Obesity
Adiposis; Heart
Keywords: Adiposis
Obesity
Acute Myocardial Infarction
Percutaneous Coronary Intervention
Left Ventricular Function
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of AMI were enrolled in this study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patient death during the follow up period
timeFrame: 1 year
Secondary outcomes:
measure: Left ventricular ejection fraction
timeFrame: 1 year
measure: Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT)
timeFrame: 1 year
measure: Infarct size as evaluated by Single-photon emission computed tomography (SPECT)
timeFrame: 1 year
measure: Number of target vessel revascularization
timeFrame: 1 year
measure: Angina class according to the canadian cardiovascular society (CCS) classification
timeFrame: 1 year
measure: Scores on the Seattle angina questionnaire
timeFrame: 1 year
measure: six-min walk distance (6MWD)
timeFrame: 1 year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Dongdong Sun, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: