Coronary AngiographyNCT03129594
Plasma Glucagon-like Peptide-1 Levels and Acute Myocardial Infarction
An observational study of Coronary Angiography and Glucagon-like Peptide-1, run by Chinese PLA General Hospital.
Trial summary
GLP-1(9-36) amide and (9-37), which was previously thought to be the inactive metabolite of GLP-1, also exerts cardioprotective effects. Direct administration of GLP-1(9-36) during reperfusion reduced ischaemic damage in isolated hearts and increased cGMP release, vasodilatation and coronary flow in AMI mouse model… 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
- What is being tested?
- plasma glucagon-like peptide-1 levels
- How many people
- 709 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to 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 18 years and older
- All sexes
- Adult, Older adult
Study population: A single center study on PCI-treated myocardial infarction patients
Who may be able to join
- consecutive patients of acute AMI come to our department,absent of cardiogenic shock, and survival for at least 24 h after PCI treatment.
Who cannot join
- patients with cancer, and patients who were taking a DPP4 inhibitor or a glucagon-like peptide-1 (GLP-1) analogue
About this study
Official title: Prognostic Value of Plasma Glucagon-like Peptide-1 Levels in Acute Myocardial Infarction
GLP-1(9-36) amide and (9-37), which was previously thought to be the inactive metabolite of GLP-1, also exerts cardioprotective effects. Direct administration of GLP-1(9-36) during reperfusion reduced ischaemic damage in isolated hearts and increased cGMP release, vasodilatation and coronary flow in AMI mouse model, one may speculate that total GLP-1 level may associate with adverse cardiovascular events in AMI patients, the hypothesis is therefore tested in this study.
- Conditions
- Coronary Angiography, Glucagon-like Peptide-1
- Being tested
- plasma glucagon-like peptide-1 levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasma glucagon-like peptide-1 levelsDiagnostic test
The plasma GLP-1 levels was determined by enzymatic assays.
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Measured: The median follow-up was 29 months
cardiovascular mortality
Measured: The median follow-up was 29 months
Secondary outcomes (5)
non-cardiovascular mortality
Measured: The median follow-up was 29 months
Myocardial infarction
Measured: The median follow-up was 29 months
heart failure readmission
readmission to any hospital due to diagnosed heart failure
Measured: The median follow-up was 29 months
Stroke
defined using the World Health Organization criteria
Measured: The median follow-up was 29 months
repeated revascularization
defined as repeated PCI or bypass grafting of not only infarct related artery
Measured: The median follow-up was 29 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study startFeb 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Enrolment
- 709 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
- NCT03129594
- Sponsor's protocol ID
- GLP1AMI
- Status last verified
- Oct 2017
- First submitted
- 23 Apr 2017
- Last updated
- 4 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Plasma Glucagon-like Peptide-1 Levels in Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03129594
- Acronym / sponsor ID
- GLP1AMI
- Conditions
- Coronary Angiography, Glucagon-like Peptide-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 709 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 26 Apr 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.
GLP-1(9-36) amide and (9-37), which was previously thought to be the inactive metabolite of GLP-1, also exerts cardioprotective effects. Direct administration of GLP-1(9-36) during reperfusion reduced ischaemic damage in isolated hearts and increased cGMP release, vasodilatation and coronary flow in AMI mouse model, one may speculate that total GLP-1 level may associate with adverse cardiovascular events in AMI patients, the hypothesis is therefore tested in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A single center study on PCI-treated myocardial infarction patients
Key inclusion criteria (1 listed)
- consecutive patients of acute AMI come to our department,absent of cardiogenic shock, and survival for at least 24 h after PCI treatment.
Key exclusion criteria (1 listed)
- patients with cancer, and patients who were taking a DPP4 inhibitor or a glucagon-like peptide-1 (GLP-1) analogue
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plasma glucagon-like peptide-1 levelsThe plasma GLP-1 levels was determined by enzymatic assays. | Diagnostic test | – |
Primary outcome
all-cause mortality
Time frame: The median follow-up was 29 months
cardiovascular mortality
Time frame: The median follow-up was 29 months
5 secondary outcomes
non-cardiovascular mortality
Time frame: The median follow-up was 29 months
Myocardial infarction
Time frame: The median follow-up was 29 months
heart failure readmission
Time frame: The median follow-up was 29 months
Stroke
Time frame: The median follow-up was 29 months
repeated revascularization
Time frame: The median follow-up was 29 months
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 4 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 Coronary Angiography 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 4 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?
all-cause mortality (time frame: The median follow-up was 29 months). The study lists 2 primary outcomes in all. 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 4 Oct 2017.