Optimized Cardioprotection Therapy in Obese Subjects With AMI

September 25, 2020 updated by: sunddong, Xijing Hospital

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of AMI were enrolled in this study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patient death during the follow up period
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Left ventricular ejection fraction
Time Frame: 1 year
1 year
Number of target vessel revascularization
Time Frame: 1 year
1 year
Angina class according to the canadian cardiovascular society (CCS) classification
Time Frame: 1 year
1 year
Scores on the Seattle angina questionnaire
Time Frame: 1 year
1 year
six-min walk distance (6MWD)
Time Frame: 1 year
1 year
Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT)
Time Frame: 1 year
1 year
Infarct size as evaluated by Single-photon emission computed tomography (SPECT)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Principal Investigator: Dongdong Sun, M.D.,Ph.D, Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2020

Primary Completion (ANTICIPATED)

October 1, 2020

Study Completion (ANTICIPATED)

December 30, 2020

Study Registration Dates

First Submitted

September 25, 2020

First Submitted That Met QC Criteria

September 25, 2020

First Posted (ACTUAL)

September 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2020

Last Update Submitted That Met QC Criteria

September 25, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OB-AMI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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