STEMI - ST Elevation Myocardial InfarctionNCT03314844
Plasma Glucagon-like Peptide-1 Levels and In-hospital Complications in ST-segment Elevation Myocardial Infarction
An observational study of STEMI - ST Elevation Myocardial Infarction and Glucagon-like Peptide-1, run by Chinese PLA General Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction, Glucagon-like Peptide-1, Bleeding
- How many people
- 564 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2013to 1 Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- a diagnosis of STEMI and needed PCI
Who cannot join
- patients with cancer patients who used DPP4 inhibitor patients who used GLP1 analogue
About this study
Official title: 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.
- Conditions
- STEMI - ST Elevation Myocardial Infarction, Glucagon-like Peptide-1, Bleeding, Complications
- Medical subject headings
- ST Elevation Myocardial Infarction, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
in-hospital complications
defined as acute heart failure, atrial fibrillation, chest pain or re-acute myocardial infarction, complete atrioventricular block, cerebrovascular disease, ventricular fibrillation or ventricular tachycardia
Measured: Time Frame: up to 2 week after PCI (until discharge)
Secondary outcomes (2)
in-hospital major adverse cardiac or cerebrovascular events
the composite of death, nonfatal MI, or stroke
Measured: Time Frame: up to 2 week after PCI (until discharge)]
in-hospital major bleeding
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
Measured: Time Frame: up to 2 week after PCI (until discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start1 Feb 2013
- Primary completion1 Feb 2015
- Study completion1 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 564 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Jing Wei, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314844
- Sponsor's protocol ID
- GLP1-IHC
- Status last verified
- Oct 2017
- First submitted
- 16 Oct 2017
- Last updated
- 20 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Glucagon-like Peptide-1 Levels Predict In-hospital Complications in ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03314844
- Acronym / sponsor ID
- GLP1-IHC
- Conditions
- STEMI - ST Elevation Myocardial Infarction, Glucagon-like Peptide-1, Bleeding, Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 1 Feb 2015 (actual)
- Study completion
- 1 Feb 2015 (actual)
- First posted
- 19 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- a diagnosis of STEMI and needed PCI
Key exclusion criteria (1 listed)
- patients with cancer patients who used DPP4 inhibitor patients who used GLP1 analogue
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
in-hospital major adverse cardiac or cerebrovascular events
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI - ST Elevation Myocardial Infarction and Glucagon-like Peptide-1, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-hospital complications (time frame: Time Frame: up to 2 week after PCI (until discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.