- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03314844
Plasma Glucagon-like Peptide-1 Levels and In-hospital Complications in ST-segment Elevation Myocardial Infarction
October 19, 2017 updated by: Li Jing Wei, Chinese PLA General Hospital
Plasma Glucagon-like Peptide-1 Levels Predict In-hospital Complications in ST-segment Elevation Myocardial Infarction
Glucagon-like peptide-1 (GLP-1), produced mainly in enteroendocrine cells, participates in energy homeostasis and glucose metabolism by regulating islet hormone secretion, gastrointestinal motility, and food intake, making GLP-1 agonist a treatment for diabetes and obesity.
Pre-clinical and clinical studies have demonstrated that GLP-1 also has cardio-protection effects.
GLP-1 agonists is able to improve markers of cardiac function, reduce myocardial infarct size and post-myocardial infarction remodeling in experimental myocardial infarction.
And GLP-1 infusion improved left ventricular function and increases myocardial salvage in patients with acute myocardial infarction (AMI).
The investigators' previous study found that GLP-1 analogues attenuated ischemia-reperfusion induced apoptosis of stem- and myocardial microvascular endothelial cells, and liraglutide (a GLP-1 analog) usage during hospital stay can prevent no-reflow and improve heart function in AMI.
Therefore, the investigators carried out a cohort study to evaluate the association between plasma GLP-1 and in-hospital complications in patients with ST-segment elevation myocardial infarction.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
564
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
PLA general hospital (PLAGH) is a large national tertiary-care center in the Beijing, China.
The investigators enrolled all patients consecutively hospitalized in PLAGH, with a diagnosis of STEMI and needed PCI
Description
Inclusion Criteria:
- a diagnosis of STEMI and needed PCI
Exclusion Criteria:
- patients with cancer patients who used DPP4 inhibitor patients who used GLP1 analogue
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
in-hospital complications
Time Frame: Time Frame: up to 2 week after PCI (until discharge)
|
defined as acute heart failure, atrial fibrillation, chest pain or re-acute myocardial infarction, complete atrioventricular block, cerebrovascular disease, ventricular fibrillation or ventricular tachycardia
|
Time Frame: up to 2 week after PCI (until discharge)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
in-hospital major adverse cardiac or cerebrovascular events
Time Frame: Time Frame: up to 2 week after PCI (until discharge)]
|
the composite of death, nonfatal MI, or stroke
|
Time Frame: up to 2 week after PCI (until discharge)]
|
|
in-hospital major bleeding
Time Frame: Time Frame: up to 2 week after PCI (until discharge)
|
defined as absolute hemoglobin drop (baseline to nadir)≥4g/dl, intracranial hemorrhage, retroperitoneal hemorrhage, use of red blood cell transfusion in patients with a baseline hemoglobin ≥9.0 g/dl, and use of red blood cell transfusion among patients with a baseline hemoglobin <9.0 g/dl and a witnessed bleeding event
|
Time Frame: up to 2 week after PCI (until discharge)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
February 1, 2013
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
October 16, 2017
First Submitted That Met QC Criteria
October 16, 2017
First Posted (Actual)
October 19, 2017
Study Record Updates
Last Update Posted (Actual)
October 20, 2017
Last Update Submitted That Met QC Criteria
October 19, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLP1-IHC
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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