Coronary AngiographyNCT02846168
Plasma GLP1 and Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention
An observational study of Coronary Angiography and Glucagon-Like Peptide 1, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the predicting role of plasma GLP1 level on major adverse cardiovascular events (MACE) in patients with acute myocardial infarction who undergo percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Angiography, Glucagon-Like Peptide 1
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with AMI who were admitted to the Chinese PLA General Hospital for pPCI
Who may be able to join
- Patients were eligible if they were 18 years or older and presented within 12 h from the onset of symptoms and signs of acute myocardial infarction to the catheterization laboratory.
Who cannot join
- Taking drugs of GLP-1 analogue and DPP4 inhibitor
- Cancer patients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Li Jing-Wei
Beijing, Beijing Municipality, 100853
Jing-Wei Li, PhD, +8601055499309, jingwei6829@sina.com
About this study
Official title: The Association of Plasma Levels of GLP1 With Prognosis of Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention
The purpose of this study is to evaluate the predicting role of plasma GLP1 level on major adverse cardiovascular events (MACE) in patients with acute myocardial infarction who undergo percutaneous coronary intervention.
Read the detailed description
Acute myocardial infarction (AMI) is associated with high mortality and its prognosis differed among patients. Primary percutaneous coronary intervention (pPCI) is an effective method to treat AMI. To accurately predict adverse outcomes following pPCI in patients with AMI will help doctors develop precise therapeutic strategy in advance. At present how to predict adverse events before pPCI is still controversial. In our previous studies, the investigators found that glucagon like peptide -1 (GLP-1) can improve cardiac function in patients with AMI after PCI, other studies have reported that plasma GLP-1 levels is negatively correlated with CK-MB in patients with AMI, but the relationship between plasma GLP1 and prognosis of AMI patients after PCI has not been reported, the investigators hypothesized that plasma levels of GLP1 is associated with major adverse cardiovascular events (MACE) after pPCI. The investigators planned to evaluate the predicting role of plasma GLP1 level on major adverse cardiovascular events (MACE) in patients with acute myocardial infarction who undergo percutaneous coronary intervention.
- Conditions
- Coronary Angiography, Glucagon-Like Peptide 1
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiovascular events (MACE) after 6 months
Measured: at 6 months
Secondary outcomes (1)
left ventricular ejection fractions
measured by transthoracic echocardiography at 3 months .
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary AngiographyStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
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
- Investigators
- Yun Dai Chen, M.D, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846168
- Sponsor's protocol ID
- GLP1-AMI
- Status last verified
- Jul 2016
- First submitted
- 12 Apr 2016
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Chen WR, Hu SY, Chen YD, Zhang Y, Qian G, Wang J, Yang JJ, Wang ZF, Tian F, Ning QX. Effects of liraglutide on left ventricular function in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. Am Heart J. 2015 Nov;170(5):845-54. doi: 10.1016/j.ahj.2015.07.014. Epub 2015 Jul 26.
PubMed 26542491Chen WR, Shen XQ, Zhang Y, Chen YD, Hu SY, Qian G, Wang J, Yang JJ, Wang ZF, Tian F. Effects of liraglutide on left ventricular function in patients with non-ST-segment elevation myocardial infarction. Endocrine. 2016 Jun;52(3):516-26. doi: 10.1007/s12020-015-0798-0. Epub 2015 Nov 16.
PubMed 26573925Chen WR, Tian F, Chen YD, Wang J, Yang JJ, Wang ZF, Da Wang J, Ning QX. Effects of liraglutide on no-reflow in patients with acute ST-segment elevation myocardial infarction. Int J Cardiol. 2016 Apr 1;208:109-14. doi: 10.1016/j.ijcard.2015.12.009. Epub 2015 Dec 15.
PubMed 26849684
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Plasma Levels of GLP1 With Prognosis of Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT02846168
- Acronym / sponsor ID
- GLP1-AMI
- Conditions
- Coronary Angiography, Glucagon-Like Peptide 1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 27 Jul 2016 (estimated)
- 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.
The purpose of this study is to evaluate the predicting role of plasma GLP1 level on major adverse cardiovascular events (MACE) in patients with acute myocardial infarction who undergo percutaneous coronary intervention.
Detailed description
Acute myocardial infarction (AMI) is associated with high mortality and its prognosis differed among patients. Primary percutaneous coronary intervention (pPCI) is an effective method to treat AMI. To accurately predict adverse outcomes following pPCI in patients with AMI will help doctors develop precise therapeutic strategy in advance. At present how to predict adverse events before pPCI is still controversial. In our previous studies, the investigators found that glucagon like peptide -1 (GLP-1) can improve cardiac function in patients with AMI after PCI, other studies have reported that plasma GLP-1 levels is negatively correlated with CK-MB in patients with AMI, but the relationship between plasma GLP1 and prognosis of AMI patients after PCI has not been reported, the investigators hypothesized that plasma levels of GLP1 is associated with major adverse cardiovascular events (MACE) after pPCI. The investigators planned to evaluate the predicting role of plasma GLP1 level on major adverse cardiovascular events (MACE) in patients with acute myocardial infarction who undergo percutaneous coronary intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with AMI who were admitted to the Chinese PLA General Hospital for pPCI
Key inclusion criteria (1 listed)
- Patients were eligible if they were 18 years or older and presented within 12 h from the onset of symptoms and signs of acute myocardial infarction to the catheterization laboratory.
Key exclusion criteria (2 listed)
- Taking drugs of GLP-1 analogue and DPP4 inhibitor
- Cancer patients
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
major adverse cardiovascular events (MACE) after 6 months
Time frame: at 6 months
1 secondary outcome
left ventricular ejection fractions
Time frame: at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
- Background: PubMed 26542491Chen WR, Hu SY, Chen YD, Zhang Y, Qian G, Wang J, Yang JJ, Wang ZF, Tian F, Ning QX. Effects of liraglutide on left ventricular function in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. Am Heart J. 2015 Nov;170(5):845-54. doi: 10.1016/j.ahj.2015.07.014. Epub 2015 Jul 26.
- Background: PubMed 26573925Chen WR, Shen XQ, Zhang Y, Chen YD, Hu SY, Qian G, Wang J, Yang JJ, Wang ZF, Tian F. Effects of liraglutide on left ventricular function in patients with non-ST-segment elevation myocardial infarction. Endocrine. 2016 Jun;52(3):516-26. doi: 10.1007/s12020-015-0798-0. Epub 2015 Nov 16.
- Background: PubMed 26849684Chen WR, Tian F, Chen YD, Wang J, Yang JJ, Wang ZF, Da Wang J, Ning QX. Effects of liraglutide on no-reflow in patients with acute ST-segment elevation myocardial infarction. Int J Cardiol. 2016 Apr 1;208:109-14. doi: 10.1016/j.ijcard.2015.12.009. Epub 2015 Dec 15.
- Individual participant dataSharing planned: Undecided
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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.
Yun Dai Chen, M.D principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Angiography and Glucagon-Like Peptide 1, run by Chinese PLA General Hospital at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing-Wei Li, PhD (+8610-55499309, jingwei6829@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiovascular events (MACE) after 6 months (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02846168, which also lists 3 linked publications.
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 27 Jul 2016.